Category: Health

Release – Mpox Clade 1 in the U.S. Highlights the Need for Vaccine Supply Diversification

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

    GeoVax Advances GEO-MVA to Strengthen U.S. and Global Readiness

    ATLANTA, GA, February 19, 2025 – The confirmation of a fourth case of Clade 1 Mpox in New York underscores the urgent need for a stronger and more diversified vaccine supply chain. GeoVax Labs, Inc. (Nasdaq: GOVX), a leader in developing vaccines and immunotherapies for infectious diseases and cancer, is calling for immediate action to expand vaccine production and ensure timely distribution.

    The spread of Clade 1 Mpox, a highly virulent and transmissible strain with a fatality rate ranging from 3% – 10%, is raising alarms across the public health community. While the virus has been a persistent threat in Africa, its increasing presence in Europe and the United States signals a critical moment in the fight against the disease. Over the last 4 months, confirmed cases of Clade 1 Mpox have been reported in California, Georgia, New Hampshire, and New York. However, the nation remains heavily dependent on a single non-U.S. vaccine manufacturer of the preferred Mpox vaccine, based on Modified Vaccinia Ankara (MVA), leaving the U.S. and global markets vulnerable to supply chain disruptions, limited accessibility, and potential vaccine shortages at a time when demand is surging.

    Current Supply Chain Inadequate for Global Mpox Response

    The current reliance on a single supplier for the preferred Mpox vaccine presents numerous challenges, particularly as the outbreak grows:

    • Supply chain instability – Depending on a single foreign manufacturer introduces geopolitical and logistical risks that could delay vaccine availability during critical outbreaks.
    • Insufficient production capacity – African health agencies have requested 20 million doses in 2025 to curb the spread of the virus, yet only 2–5 million doses are expected to be available.
    • High costs and limited access – At as much as $270 per dose in the U.S., the preferred product for vaccination against Mpox can be prohibitively expensive for many, creating a barrier to widespread vaccination efforts.
    • Inability to respond swiftly to emerging strains – Current stockpiles, which were depleted during the 2022 outbreak, are likely inadequate to combat the increasing spread of Clade 1, leaving public health officials struggling to contain the outbreak.

    GeoVax’s GEO-MVA: A Critical Additional-Source Solution

    In response to these pressing concerns, GeoVax is advancing development of GEO-MVA, an alternative MVA based vaccine in the fight against Mpox. GeoVax is also further addressing vaccine availability with plans to transition manufacturing of GEO-MVA, once authorized, to an advanced MVA manufacturing platform with the potential to offer significant advantages over the currently utilized Chicken Embryo Fibroblast (CEF) manufacturing platform, a complicated manufacturing process highly dependent on the availability of Specific Pathogen Free (SPF) chicken eggs. GEO-MVA’s innovative MVA production process, once implemented, should enable:

    • Scalability for global demand – Rapid, high-volume manufacturing to meet urgent vaccination needs.
    • Flexibility to utilize existing vaccine manufacturing facilities vs need to construct new ones.
    • Lower cost and increased accessibility – The advanced technology behind GeoVax’s MVA manufacturing platform should help reduce production costs, making vaccination programs more affordable worldwide.
    • Eliminate the need for SPF eggs whose availability can be negatively impacted by supply disruptions such as those related to avian flu outbreaks.
    • Strengthening U.S. biosecurity – Unlike the current MVA vaccine, which is produced overseas, GEO-MVA can be manufactured within the U.S., reducing reliance on foreign supply chains.
    • Enhanced pandemic preparedness – A diversified vaccine supply ensures greater resilience in response to future outbreaks, preventing disruptions in availability.

    GeoVax has established strategic partnerships with OXB (France) and ProBioGen (Berlin) to support production scale up, while also actively engaging with U.S. and international health agencies to potentially expedite regulatory approvals and secure funding to bring GEO-MVA to market and eventually transition production to the next generation MVA manufacturing process. GeoVax recently completed cGMP (current Good Manufacturing Practice) manufacturing of the GEO-MVA drug substance and is currently in the process of fill-finish, with anticipated availability of clinical vialed material by mid-year.

    A Call to Action: Strengthening the Global Response

    With the growing threat of Clade 1 Mpox, it is imperative to diversify vaccine manufacturing capabilities and ensure the U.S. and global health agencies have access to multiple suppliers. GeoVax urges policymakers and regulators to take decisive action:

    • Increase federal funding and policy support to expedite the availability of GEO-MVA as an alternative Mpox vaccine.
    • Expedite regulatory approvals to bring GEO-MVA to market as quickly as possible.
    • Enhance collaboration with global health organizations to ensure equitable vaccine distribution, particularly in underserved regions.

    “We cannot afford to wait for another pandemic-level crisis before addressing vaccine shortages and supply chain vulnerabilities,” said David Dodd, Chairman & CEO of GeoVax. “The emergence of Clade 1 Mpox in the U.S. is a clear warning sign. Immediate action is needed to strengthen vaccine supply and access.  GEO-MVA, along with our efforts towards establishing our next generation MVA manufacturing platform, represents critical solutions to ensure we are better prepared for future outbreaks.”

    About GeoVax

    GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines for many of the world’s most threatening infectious diseases and therapies for solid tumor cancers. The company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine for which GeoVax was recently awarded a BARDA-funded contract to sponsor a 10,000-participant Phase 2b clinical trial to evaluate the efficacy of GEO-CM04S1 versus an approved COVID-19 vaccine. In addition, GEO-CM04S1 is currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. A Phase 2 clinical trial in first recurrent head and neck cancer, evaluating Gedeptin® combined with an immune checkpoint inhibitor is planned. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. The Company has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.

    Forward-Looking Statements

    This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

    Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. 

    Company Contact:                                                                              

    info@geovax.com                     

    678-384-7220                            

    Investor Relations Contact:

    austin.murtagh@precisionaq.com

    212-698-8696

    Media Contact:

    sr@roberts-communications.com

    202-779-0929

    Release – MAIA Biotechnology Announces Private Placement of $2,715,000

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on MAIA

    February 18, 2025 3:44pm EST Download as PDF

    CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that it has entered into definitive agreements for the purchase and sale of an aggregate of 1,810,000 shares of common stock at a purchase price of $1.50 per share, in a private placement to accredited investors and certain Company directors. Each share of common stock is being offered together with a warrant to purchase one share of common stock at an exercise price of $1.87 per share, which price represents the greater of the book or market value of the stock on the date the definitive agreements were executed (subject to customary adjustments as set forth in the warrants). The warrants are exercisable commencing one year following issuance and have a term of six years from the initial issuance date. The securities being sold to the Company director participating in the offering are being issued pursuant to the Company’s 2021 Equity Incentive Plan. The private placement is expected to close on or about February 20, 2025, subject to the satisfaction of customary closing conditions.

    The gross proceeds from the offering are expected to be $2,715,000, prior to offering expenses payable by the Company. The Company intends to use the net proceeds received from the private placement to fund the starting cost for Part C of the Phase II trial THIO -101 and for working capital.

    The securities described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    About MAIA Biotechnology, Inc.

    MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.

    Forward Looking Statements

    MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates; (viii) the completion of the offering and (ix) the satisfaction of customary closing conditions related to the offering, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.

    Investor Relations Contact
    +1 (872) 270-3518
    ir@maiabiotech.com

    Source: MAIA Biotechnology, Inc.

    Released February 18, 2025

    Release – GeoVax Pledges Continued Support for Vaccine Innovation, Transparency, and Public Health

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on GOVX

    GeoVax’s Vaccine Development Programs Align with Anticipated HHS Focus on Vaccine Safety, Diversification and Domestic Biosecurity

    ATLANTA, GA, February 18, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a leader in vaccine and immunotherapy development, congratulates Robert F. Kennedy, Jr. on his confirmation as Secretary of the U.S. Department of Health and Human Services (HHS). RFK Jr.’s appointment provides a significant opportunity for healthcare innovation, transparency, and public trust, reinforcing national priorities such as vaccine safety, diversified vaccine platforms, and strengthened domestic manufacturing. GeoVax stands ready to support these initiatives by delivering next-generation vaccines and advanced vaccine manufacturing technology that enhance biosecurity, public health resilience, and vaccine confidence.

    GeoVax’s Commitment to a Robust, Transparent and Secure Vaccine Future

    GeoVax’s mission aligns closely with the new administration’s policy priorities, particularly in reducing reliance on foreign pharmaceutical supply chains, increasing vaccine safety and durability, and ensuring access for underserved populations. The Company’s proprietary Modified Vaccinia Ankara (MVA) platform offers a promising alternative to other vaccine technologies such as mRNA, providing broad-spectrum, durable immunity across multiple infectious diseases via a recognized safe vaccine platform.

    Key initiatives supporting the goals for vaccine safety and transparency include:

    • Diversified Vaccine Development – GeoVax’s GEO-CM04S1, a next-generation COVID-19 vaccine, and GEO-MVA, a dual-purpose Mpox and smallpox vaccine, align with the advocacy for alternative vaccine platforms beyond mRNA. These vaccines are designed to offer long-term immunity with a well-documented safety profile.
    • Transparency as a Pillar of Public Trust – As David Dodd, Chairman and CEO of GeoVax, has emphasized, restoring trust in vaccines requires clear communication, open regulatory processes, and full transparency regarding safety, efficacy, and potential risks. GeoVax supports the call for greater industry accountability and public engagement, ensuring that vaccine development aligns with the highest standards of ethical science.
    • Strengthening U.S. Biosecurity – GeoVax’s anticipated domestic vaccine manufacturing capabilities reinforce the bipartisan legislative commitment to reducing dependence on foreign pharmaceutical supply chains, thereby enhancing national pandemic preparedness.
    • Ethical Vaccine Development & Public Confidence – GeoVax embraces open regulatory processes, rigorous safety standards, and public access to data, ensuring confidence in its vaccines. These principles align with the call for increased scrutiny and transparency in vaccine development and approval.
    • Equitable Access & Global Preparedness – With cost-effective, scalable technology that does not require ultra-cold storage, GeoVax’s vaccines are well-suited for domestic and global distribution, ensuring broad access to critical immunizations, particularly for immunocompromised and underserved communities.

    David Dodd: “Transparency is the Key to Restoring Vaccine Trust”

    Reflecting on the challenges of vaccine hesitancy, David Dodd has been a vocal advocate for transparency in vaccine development and regulatory processes. In a recent op-ed, he emphasized: “Trust in vaccines has become a critical battleground for public health. Addressing public concerns openly and honestly is the only way to bridge the growing divide between science and skepticism. Transparency is a necessity, not an option. GeoVax remains committed to clear communication, scientific integrity, and ensuring that public confidence in vaccines is based on facts, not fear.” (https://www.genengnews.com/topics/translational-medicine/a-call-to-action-building-vaccine-trust-through-transparency/)

    This perspective directly supports the stated goals of strengthening public trust, reducing regulatory opacity, and ensuring vaccine safety through independent oversight. GeoVax’s proactive approach to transparent vaccine development is a model for responsible biotech leadership.

    A New Era for U.S. Healthcare and Pandemic Preparedness

    RFK Jr.’s confirmation as HHS Secretary provides a renewed opportunity in support of vaccine diversification, transparency, and strategic biomanufacturing initiatives. GeoVax’s innovative vaccine pipeline supports these goals, positioning the Company as a vital partner in safeguarding national and global public health.

    GeoVax’s vaccine development strategy builds upon successful national initiatives, such as Operation Warp Speed and Project NextGen, by prioritizing pandemic preparedness and biosecurity resilience. Through continued engagement with federal agencies and global health organizations, the Company seeks to accelerate vaccine development, expand domestic manufacturing, and enhance pandemic response efforts.

    David Dodd, Chairman and CEO of GeoVax, stated: “Secretary Kennedy’s confirmation presents an opportunity to redefine public health with greater emphasis on safety, accessibility, and innovation. GeoVax proudly supports the commitment to reducing dependence on foreign pharmaceutical supply chains, diversifying vaccine technology, and restoring trust in public health solutions. We stand ready to collaborate with HHS and other healthcare stakeholders to advance a safer, more resilient healthcare future.”

    About GeoVax

    GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines for many of the world’s most threatening infectious diseases and therapies for solid tumor cancers. The company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine for which GeoVax was recently awarded a BARDA-funded contract to sponsor a 10,000-participant Phase 2b clinical trial to evaluate the efficacy of GEO-CM04S1 versus an approved COVID-19 vaccine. In addition, GEO-CM04S1 is currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. A Phase 2 clinical trial in first recurrent head and neck cancer, evaluating Gedeptin® combined with an immune checkpoint inhibitor is planned. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. The Company has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.

    Forward-Looking Statements

    This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

    Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. 

    Company Contact: Investor Relations Contact: Media Contact:
    info@geovax.com                             austin.murtagh@precisionaq.com                         sr@roberts-communications.com 
    678-384-7220 212-698-8696 202-779-0929

    Release – Nutriband and Kindeva formalize exclusive product development partnership and long-term commitment based on shared development costs in exchange for milestone payments

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on NTRB

    Nutriband is partnering with Kindeva Drug Delivery to develop Aversa™ Fentanyl which combines Nutriband’s Aversa™ abuse-deterrent technology with Kindeva’s FDA-approved fentanyl patch.

    ORLANDO, Fla., Feb. 13, 2025 (GLOBE NEWSWIRE) — Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW), a company engaged in the development of prescription transdermal pharmaceutical products, today announced that it has signed an addendum to the Commercial Development and Clinical Supply Agreement for its lead product, Aversa™ Fentanyl, that it has in place with its partner, Kindeva Drug Delivery, a leading global contract development and manufacturing organization (CDMO) focused on drug-device combination products.

    Nutriband and Kindeva have revised their agreement to formalize their exclusive product development partnership and long-term commitment based on shared development costs in exchange for milestone payments.

    Nutriband’s AVERSA™ abuse-deterrent technology can be utilized to incorporate aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential including opioids and stimulants.

    Nutriband’s abuse-deterrent transdermal technology consists of a proprietary aversive agent coating that employs taste aversion to deter the oral abuse of and accidental exposure to transdermal opioid and stimulant patch products.

    The AVERSA™ abuse deterrent technology is protected by a broad international intellectual property portfolio with patents issued in 46 countries including the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia.

    AVERSA Fentanyl has the potential to be the world’s first abuse-deterrent opioid patch designed to deter the abuse and misuse and reduce the risk of accidental exposure of transdermal fentanyl patches. AVERSA Fentanyl has the potential to reach peak annual US sales of $80 million to $200 million.1

    1 Health Advances Aversa Fentanyl market analysis report 2022

    About AVERSA™ Abuse-Deterrent Transdermal Technology

    Nutriband’s AVERSA™ abuse-deterrent transdermal technology incorporates aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential. The AVERSA™ abuse-deterrent technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse, such as fentanyl, while making sure that these drugs remain accessible to those patients who really need them. The technology is covered by a broad intellectual property portfolio with patents granted in the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia.

    About Nutriband Inc.

    We are primarily engaged in the development of a portfolio of transdermal pharmaceutical products. Our lead product under development is an abuse-deterrent fentanyl patch incorporating our AVERSA™ abuse-deterrent technology. AVERSA™ technology can be incorporated into any transdermal patch to prevent the abuse, misuse, diversion, and accidental exposure of drugs with abuse potential.

    The Company’s website is www.nutriband.com. Any material contained in or derived from the Company’s websites or any other website is not part of this press release.

    Forward-Looking Statements

    Certain statements contained in this press release, including, without limitation, statements containing the words “believes,” “anticipates,” “expects” and words of similar import, constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve both known and unknown risks and uncertainties. The Company’s actual results may differ materially from those anticipated in its forward-looking statements as a result of a number of factors, including those including the Company’s ability to develop its proposed abuse-deterrent fentanyl transdermal system and other proposed products, its ability to obtain patent protection for its abuse technology, its ability to obtain the necessary financing to develop products and conduct the necessary clinical testing, its ability to obtain Federal Food and Drug Administration approval to market any product it may develop in the United States and to obtain any other regulatory approval necessary to market any product in other countries, including countries in Europe, its ability to market any product it may develop, its ability to create, sustain, manage or forecast its growth; its ability to attract and retain key personnel; changes in the Company’s business strategy or development plans; competition; business disruptions; adverse publicity and international, national and local general economic and market conditions and risks generally associated with an undercapitalized developing company, as well as the risks contained under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s Form S-1, Form 10-K for the year ended January 31, 2024, filed May 1, 2024, the Forms 10-Q’s filed subsequent to the Form 10-K in 2024, and the Company’s other filings with the Securities and Exchange Commission. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statements to reflect any event or circumstance that may arise after the date hereof.

    AbbVie and Xilio Therapeutics Collaborate to Develop Tumor-Activated Immunotherapies

    Posted on by slightbourne@noblecapitalmarkets.com
    Key Points:
    – AbbVie and Xilio Therapeutics announce a partnership to develop innovative tumor-activated immunotherapies, including masked T-cell engagers.
    – Xilio will receive $52 million upfront and is eligible for up to $2.1 billion in milestone payments and royalties.
    – The collaboration aims to enhance the effectiveness of immunotherapy while minimizing systemic side effects.

    AbbVie and Xilio Therapeutics have entered a strategic collaboration to advance next-generation tumor-activated immunotherapies, a move that could significantly impact the oncology space. The partnership will focus on developing masked T-cell engagers (TCEs), a cutting-edge approach designed to precisely target tumors while reducing the systemic toxicity often associated with immunotherapies.

    Under the terms of the agreement, Xilio will receive an upfront payment of $52 million, with the potential to earn up to $2.1 billion in milestone payments and royalties if the collaboration yields successful drug candidates. This deal highlights the growing interest in tumor-selective therapies as biopharmaceutical companies seek to refine cancer treatments for better efficacy and safety.

    Immunotherapy has revolutionized cancer treatment over the past decade, with checkpoint inhibitors and CAR-T therapies offering promising results. However, many of these treatments come with serious side effects, such as cytokine release syndrome and immune-related toxicities, which can limit their widespread use. Tumor-activated therapies, like those being developed through the AbbVie-Xilio collaboration, aim to overcome these challenges by ensuring immune system activation occurs predominantly at the tumor site rather than throughout the body.

    This strategy aligns with a broader industry trend where major pharmaceutical companies are investing heavily in precision oncology. Companies such as Bristol Myers Squibb, Merck, and Roche are also exploring targeted immune therapies, with some already advancing their own masked TCE platforms.

    AbbVie’s decision to partner with Xilio follows similar collaborations between biotech startups and large pharmaceutical firms. Smaller biotech companies often bring innovative drug discovery capabilities, while established players like AbbVie provide the resources and expertise needed to navigate clinical development and regulatory approval.

    The move also positions AbbVie competitively in the immuno-oncology space, where it faces increasing competition from global drugmakers. The company has been expanding its oncology pipeline following the success of Imbruvica and Venclexta, and this partnership could strengthen its position in the next generation of cancer therapeutics.

    Meanwhile, Xilio Therapeutics, a biotech firm specializing in tumor-selective treatments, stands to gain significant financial backing and research support through this agreement. Its proprietary technology platform, which develops highly potent, tumor-activated biologics, has the potential to redefine immunotherapy approaches for solid tumors.

    With oncology continuing to be one of the most lucrative and rapidly evolving fields in biotech, tumor-activated immunotherapies are poised to become a major focus of drug development. The potential to minimize toxicity while enhancing efficacy makes these therapies particularly appealing for both patients and healthcare providers.

    If successful, the AbbVie-Xilio collaboration could lead to groundbreaking advancements in cancer treatment, opening doors for future partnerships and expanding the role of tumor-targeted biologics in oncology.

    Take a moment to take a look at Noble Capital Markets Senior Research Analyst Robert LeBoyer’s life sciences and biotechnology coverage list.

    Release – Nutriband Receives Notice Of Allowance For New U.S. Patent Covering Its Transdermal Abuse Deterrent Technology Aversa™

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on NTRB

    The AVERSA™ transdermal abuse deterrent technology is protected by a broad international intellectual property portfolio with patents already issued in 46 countries including the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia

    February 07, 2025 08:45 ET 

    ORLANDO, Fla., Feb. 07, 2025 (GLOBE NEWSWIRE) — Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW), a company engaged in the development of prescription transdermal pharmaceutical products, today announced that it received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) on February 3, 2025 for patent application 18/369,241, “Abuse and Misuse Deterrent Transdermal Systems” which covers its Aversa™ abuse deterrent technology. The receipt of a Notice of Allowance means that the USPTO is expected to issue a U.S. patent for this application after administrative processes have been completed.

    The expected issuance of this patent further expands Nutriband’s intellectual property protection in the United States for its portfolio of abuse deterrent transdermal products based on its proprietary Aversa™ abuse deterrent technology. This technology can be incorporated into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential. Nutriband’s lead product under development is Aversa™ Fentanyl, an abuse deterrent fentanyl transdermal system, with the potential to become the first and only abuse deterrent pain patch on the market.

    Nutriband’s AVERSA™ abuse-deterrent technology can be utilized to incorporate aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential including opioids and stimulants. The technology consists of a proprietary aversive agent coating that employs taste aversion to deter the oral abuse of and accidental exposure to transdermal opioid and stimulant patch products.

    The AVERSA™ abuse deterrent technology is protected by a broad international intellectual property portfolio with patents issued in 46 countries including the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia.

    AVERSA Fentanyl has the potential to be the world’s first abuse-deterrent opioid patch designed to deter the abuse and misuse and reduce the risk of accidental exposure of transdermal fentanyl patches. AVERSA Fentanyl has the potential to reach peak annual US sales of $80 million to $200 million.1

    ____________________________________________

    1 Health Advances Aversa Fentanyl market analysis report 2022

    About AVERSA™ Abuse-Deterrent Transdermal Technology

    Nutriband’s AVERSA™ abuse-deterrent transdermal technology incorporates aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential. The AVERSA™ abuse-deterrent technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse, such as fentanyl, while making sure that these drugs remain accessible to those patients who really need them. The technology is covered by a broad intellectual property portfolio with patents granted in the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia.

    About Nutriband Inc.

    We are primarily engaged in the development of a portfolio of transdermal pharmaceutical products. Our lead product under development is an abuse-deterrent fentanyl patch incorporating our AVERSA™ abuse-deterrent technology. AVERSA™ technology can be incorporated into any transdermal patch to prevent the abuse, misuse, diversion, and accidental exposure of drugs with abuse potential.

    The Company’s website is www.nutriband.com. Any material contained in or derived from the Company’s websites or any other website is not part of this press release.

    Forward-Looking Statements

    Certain statements contained in this press release, including, without limitation, statements containing the words “believes,” “anticipates,” “expects” and words of similar import, constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve both known and unknown risks and uncertainties. The Company’s actual results may differ materially from those anticipated in its forward-looking statements as a result of a number of factors, including those including the Company’s ability to develop its proposed abuse-deterrent fentanyl transdermal system and other proposed products, its ability to obtain patent protection for its abuse technology, its ability to obtain the necessary financing to develop products and conduct the necessary clinical testing, its ability to obtain Federal Food and Drug Administration approval to market any product it may develop in the United States and to obtain any other regulatory approval necessary to market any product in other countries, including countries in Europe, its ability to market any product it may develop, its ability to create, sustain, manage or forecast its growth; its ability to attract and retain key personnel; changes in the Company’s business strategy or development plans; competition; business disruptions; adverse publicity and international, national and local general economic and market conditions and risks generally associated with an undercapitalized developing company, as well as the risks contained under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s Form S-1, Form 10-K for the year ended January 31, 2024, filed May 1, 2024, the Forms 10-Q’s filed subsequent to the Form 10-K in 2024, and the Company’s other filings with the Securities and Exchange Commission. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statements to reflect any event or circumstance that may arise after the date hereof.

    Contact Information:

    Nutriband Inc.
    Phone: 407-377-6695
    Email: Support@nutriband.com

    SOURCE: Nutriband Inc.

    Release – Eledon Pharmaceuticals Announces Use of Tegoprubart as Key Component of Immunosuppression Regimen in its Second Transplant of a Genetically Modified Pig Kidney into a Human

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on ELDN

    February 7, 2025

    PDF Version

    Patient treated in procedure, conducted at Mass General Transplant Center and in collaboration with partner eGenesis, was recently released from hospital

    Investigational therapy tegoprubart targets CD40 ligand (CD40L) with potential to improve both safety and efficacy compared to standard of care immunosuppression regimens

    IRVINE, Calif., Feb. 07, 2025 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today announced that tegoprubart, the company’s investigational anti-CD40L antibody, was used as a key component of the immunosuppression therapy regimen in a patient who recently received a transplanted kidney from a genetically modified pig. The procedure was performed on January 25, 2025, by surgeons at Massachusetts General Hospital (MGH) in collaboration with our partner eGenesis. In December 2024, MGH received Food and Drug Administration (FDA) approval to proceed with this transplant and plans to perform two additional xenotransplants this year, further advancing the field of xenotransplantation. Following the successful transplant, the patient was discharged from the hospital and is now off dialysis for the first time in over two years.

    “This second kidney xenotransplant conducted at MGH represents another important milestone in the effort to consider new strategies in transplantation and immunosuppression to address the global organ shortage crisis. We are grateful to the patient, the team at MGH, and our partner eGenesis for supporting tegoprubart’s central role in these landmark procedures,” said David-Alexandre C. Gros, M.D., Eledon Chief Executive Officer. “Blocking the CD40 Ligand is a critical component of the immunosuppression regimen for effective translation of organ transplant from nonhuman primates into humans. Our anti-CD40L antibody tegoprubart represents a novel approach to immunosuppression therapy with the potential to improve safety and efficacy and enable patients to live longer with their transplanted organs.”

    Similar to the first-ever kidney xenotransplant, also conducted at MGH in March 2024, tegoprubart is being administered to the current patient investigationally as part of a regimen designed to prevent the body from rejecting the transplanted pig organ. Tegoprubart is designed to block CD40L and has been shown to inhibit multiple costimulatory receptors including CD40 and CD11, key components of how immune cells communicate with one another. Based on extensive prior research, tegoprubart has been observed to be generally safe and well-tolerated in multiple potential indications, including for the prevention of rejection following kidney allotransplantation.

    “I would like to thank Eledon for their work supporting this historic xenotransplant. Immunosuppression presents one of the greatest challenges for transplantation in both human and non-human organs. The need for advancements in immunosuppressive medications is critical for advancing our field and improving the quality of life for transplant patients everywhere,” said Dr. Leonardo Riella, MD, PhD, Medical Director for Kidney Transplantation at Massachusetts General Hospital.

    Tegoprubart was also used as a cornerstone component of the chronic immunosuppression regimen administered following the second-ever transplant of a genetically modified heart from a pig to a human, performed at the University of Maryland Medical Center in September 2023. Currently, tegoprubart is being evaluated in three global clinical studies for the prevention of organ rejection in patients receiving kidney transplants and in a separate investigator sponsored trial for the prevention of islet transplant rejection in patients with type 1 diabetes (T1D). Eledon recently announced initial data from this investigator-initiated islet transplant trial, conducted by the research team at the University of Chicago Medicine Transplant Institute, that demonstrated potentially the first human cases of insulin independence achieved using an anti-CD40L monoclonal antibody therapy without the use of tacrolimus, the current standard of care for prevention of transplant rejection.

    The Company plans to report updated interim clinical trial from its ongoing Phase 1b and long-term safety and efficacy extension studies in kidney transplant this summer, topline results from its Phase 2 BESTOW kidney transplant trial in the fourth quarter of 2025, and longer-term follow up results from the investigator-led islet transplant clinical trial at UChicago Medicine Transplant Institute later this year.

    About Eledon Pharmaceuticals and tegoprubart

    Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.

    Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter

    Forward-Looking Statements

    This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about planned clinical trials, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sites, as well as patient enrollment; risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials; and risks associated with the impact of the ongoing coronavirus pandemic. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Investor Contact:

    Stephen Jasper
    Gilmartin Group
    (858) 525 2047
    stephen@gilmartinir.com 

    Media Contact:

    Jenna Urban
    CG Life
    (212) 253 8881
    jurban@cglife.com 

    Source: Eledon Pharmaceuticals

    Release – Tonix Pharmaceuticals Recently Announced Preliminary Full Year 2024 Operating Results and Year-End Cash

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on TNXP

    February 07, 2025 8:30am EST Download as PDF

    Company had $98.8 million in cash as of December 31, 2024; existing cash expected to fund planned operations into the first quarter of 2026

    Company is debt-free after repaying mortgage on facilities

    TNX-102 SL fibromyalgia FDA PDUFA goal date is August 15, 2025

    $10.1 million in net sales from migraine products in 2024

    CHATHAM, N.J., Feb. 07, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, recently announced selected preliminary operating results for the year ended December 31, 2024, and certain preliminary financial condition information as of December 31, 2024.

    Preliminary Full Year 2024 Financial Results1

    • The Company had approximately $98.8 million in cash and cash equivalents as of December 31, 2024.
    • Net cash used in operating activities was approximately $60.9 million, compared to $102.0 million for the prior year.
    • Capital expenditures was approximately $0.1 million, compared to $29.1 million for the prior year.
    • Net operating loss was approximately $126.6 million, which includes non-cash impairment charges of approximately $59.0 million, compared to net operating loss of $116.7 million for the prior year.
    • The Company announced that net revenue from the sale of its marketed products was approximately $10.1 million, compared to $7.8 million for the prior year.
    • On February 3, 2025, the Company repaid a mortgage (Loan and Guaranty Agreement) with JGB Capital and related parties that was secured by two facilities and the Company is now debt-free.

    The Company expects that its cash resources at December 31, 2024, and the gross proceeds of approximately $30.4 million raised from sales under its at-the-market facility in the first quarter of 2025, will be sufficient to fund its planned operations into the first quarter of 2026.

    The cash runway is expected to fund the company beyond the August 15, 2025 Prescription Drug User Fee Act (PDUFA) goal date assigned by the U.S. Food and Drug Administration (FDA) for a decision on marketing authorization for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg for the management of fibromyalgia. 

    1 The above information is preliminary financial information for the year ended December 31, 2024 and subject to completion. The unaudited, estimated results for the year ended December 31, 2024 are preliminary and were prepared by the Company’s management, based upon its estimates, a number of assumptions and currently available information, and are subject to revision based upon, among other things, quarter and year-end closing procedures and/or adjustments, the completion of the Company’s consolidated financial statements and other operational procedures. This preliminary financial information is the responsibility of management and has been prepared in good faith on a consistent basis with prior periods. However, the Company has not completed its financial closing procedures for the year ended December 31, 2024, and its actual results could be materially different from this preliminary financial information, which preliminary information should not be regarded as a representation by the Company or its management as to its actual results for the year ended December 31, 2024. In addition, EisnerAmper LLP, the Company’s independent registered public accounting firm, has not audited, reviewed, compiled, or performed any procedures with respect to this preliminary financial information and does not express an opinion or any other form of assurance with respect to this preliminary financial information. During the course of the preparation of the Company’s financial statements and related notes as of and for the year ended December 31, 2024, the Company may identify items that would require it to make material adjustments to this preliminary financial information. As a result, prospective investors should exercise caution in relying on this information and should not draw any inferences from this information. This preliminary financial information should not be viewed as a substitute for full financial statements prepared in accordance with United States generally accepted accounting principles and reviewed by the Company’s auditors.

    Tonix Pharmaceuticals Holding Corp.*

    Tonix is a fully-integrated biopharmaceutical company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to advance TNX-102 SL, a product candidate for the management of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing authorization. The FDA has also granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation, and its development is supported by a grant from the National Institute on Drug Abuse. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in infectious disease, including a vaccine for mpox, TNX-801. Tonix recently announced a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years to develop TNX-4200, small molecule broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.

    * Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.

    Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.

    This press release and further information about Tonix can be found at www.tonixpharma.com.

    Forward Looking Statements

    Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

    Investor Contact

    Jessica Morris
    Tonix Pharmaceuticals
    investor.relations@tonixpharma.com
    (862) 799-8599

    Peter Vozzo
    ICR Healthcare
    peter.vozzo@icrhealthcare.com
    (443) 213-0505

    Media Contact

    Ray Jordan
    Putnam Insights
    ray@putnaminsights.com
    (949) 245-5432

    Indication and Usage

    Zembrace® SymTouch® (sumatriptan succinate) injection (Zembrace) and Tosymra® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.

    Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age.

    Important Safety Information

    Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:

    • discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
    • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
    • pain or discomfort in your arms, back, neck, jaw or stomach
    • shortness of breath with or without chest discomfort
    • breaking out in a cold sweat
    • nausea or vomiting
    • feeling lightheaded

    Zembrace and Tosymra are not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem.

    Do not use Zembrace or Tosymra if you have:

    • history of heart problems
    • narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
    • uncontrolled high blood pressure
    • hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
    • had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
    • severe liver problems
    • taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure.
    • are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
    • an allergy to sumatriptan or any of the components of Zembrace or Tosymra

    Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.

    Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.

    Zembrace and Tosymra may cause serious side effects including:

    • changes in color or sensation in your fingers and toes
    • sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
    • cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
    • increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
    • medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
    • serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
    • hives (itchy bumps); swelling of your tongue, mouth, or throat
    • seizures even in people who have never had seizures before

    The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrace only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only).

    Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider.

    This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633.

    You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

    Primary Logo

    Source: Tonix Pharmaceuticals Holding Corp.

    Released February 7, 2025

    Release – Cadrenal Therapeutics Announces Chief Medical Officer Transition to Advance Clinical Development of Tecarfarin

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on CVKD

    • James J. Ferguson, MD, FACC, FAHA, joins as Chief Medical Officer
    • Extensive experience provides strong support for advancing specialized cardiovascular assets, including leading the late-stage clinical development of tecarfarin and other business development opportunities

    PONTE VEDRA, Fla. – Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a late-stage biopharmaceutical company focused on the development of specialized cardiovascular therapies, with the late-stage asset tecarfarin, a new Vitamin K antagonist, today announced a leadership transition appointing James J. Ferguson, MD, FACC, FAHA, as its new Chief Medical Officer, effective immediately. Dr. Ferguson is a distinguished medical expert with over 25 years of leadership in the cardiovascular field and deep expertise in clinical development. Dr. Ferguson will lead the late-stage clinical development of tecarfarin to include the pivotal trial in LVAD patients and other indications in rare cardiovascular conditions requiring life-long anticoagulation therapy as well as other business development opportunities to build the Company’s pipeline.

    Dr. Ferguson replaces Douglas W. Losordo, MD. Cadrenal thanks Dr. Douglas Losordo for his contributions to advancing the development of our tecarfarin program.

    “We welcome Dr. Ferguson to our team and are confident that he will play a critical role in driving the late-stage clinical development of tecarfarin and the prioritization of indications. Dr. Ferguson brings expertise and strong relationships with cardiovascular clinical and scientific thought leadership, which will be instrumental as we prepare for late-stage clinical development of our tecarfarin program,” said Quang X. Pham, Chief Executive Officer, Cadrenal Therapeutics, Inc.

    Dr. Ferguson joins Cadrenal after serving as Chief Medical Officer at Matinas BioPharma. Previously, Dr. Ferguson was Head of U.S. Cardiovascular Medical Affairs at Amgen and held several senior positions at AstraZeneca, including Vice President of US Cardiovascular Medical and Scientific External Relations, Therapeutic Area Vice President of Cardiovascular Global Medical Affairs, and US Development brand leader for BRILINTA.

    “I’m truly honored to be joining Cadrenal at this exciting and transformative time. I look forward to advancing the late-stage clinical development of tecarfarin and bringing forward the first innovation in vitamin K-targeted anticoagulation in 70 years. This product could have a truly meaningful impact for patients in whom there continues to be major unmet medical needs with standard warfarin therapy,” said Dr. Ferguson.

    About Cadrenal Therapeutics, Inc.

    Cadrenal Therapeutics, Inc. is a late-stage biopharmaceutical company focused on developing specialized therapeutics for rare cardiovascular conditions. The Company is developing tecarfarin, a vitamin K antagonist (VKA) designed to be a better and safer anticoagulant than warfarin for individuals with implanted cardiac devices. Cadrenal strives to improve outcomes and reduce major adverse events for these patients. Although warfarin is widely used off-label for several rare cardiovascular diseases, extensive clinical and real-world data have shown it to have significant serious side effects. With its innovation, Cadrenal aims to meet the unmet needs of this patient population by relieving them and their healthcare providers of some of warfarin’s greatest clinical challenges.

    Cadrenal is pursuing a product in a pipeline approach with tecarfarin. Tecarfarin received Orphan Drug designation (ODD) for advanced heart failure patients with implanted left ventricular assist devices (LVADs). In 2025, the Company plans to initiate a pivotal Phase 3 trial evaluating tecarfarin versus warfarin for LVAD patients. The Company also received ODD and fast-track status for tecarfarin in end-stage kidney disease and atrial fibrillation (ESKD+AFib).

    Cadrenal is opportunistically pursuing business development initiatives with a longer-term focus to build a pipeline of specialized cardiovascular therapies. For more information, visit www.cadrenal.com and connect with us on LinkedIn.

    Safe Harbor

    Any statements contained in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include statements regarding the contributions to be made by Dr. Ferguson including leading the late-stage clinical development of tecarfarin to include the pivotal trial in LVAD patients and other indications in rare cardiovascular conditions requiring life-long anticoagulation therapy as well as other business development opportunities to build the Company’s pipeline, as well as advancing other indications in rare cardiovascular conditions requiring chronic anticoagulation; playing a critical role in driving the late-stage clinical development of tecarfarin and the prioritization of indications; Dr. Ferguson’s expertise and strong relationships with cardiovascular clinical and scientific thought leadership being instrumental as the Company prepares for the for late-stage clinical development of our tecarfarin programs; advancing the late-stage clinical development of tecarfarin and bringing forward the first innovation in vitamin K-targeted anticoagulation in 70 years; the product having a truly meaningful impact for patients in whom there continues to be major unmet medical needs with standard warfarin therapy; the Company striving to improve outcomes and reduce major adverse events for patients; the Company aiming to meet the unmet needs of the patient population by relieving them and their healthcare providers of some of warfarin’s greatest clinical challenges; and the Company initiating in 2025 a pivotal Phase 3 trial evaluating tecarfarin versus warfarin for LVAD patients. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to derive benefits from the contributions expected to be made by Dr. Ferguson; the ability to initiate the pivotal Phase 3 clinical trial for tecarfarin in LVAD patients in 2025 and provide improved outcomes; the ability to enter into collaborations with development partners; the ability of tecarfarin to provide a safer alternative to LVAD patients and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, and the Company’s subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.

    Lisa DeScenza

    LaVoieHealthScience

    (978) 395-5970

    ldescenza@lavoiehealthscience.com

    Release – Tonix Pharmaceuticals Announces Positive Topline Results from Phase 1 Trial for TNX-1500, a Next Generation anti-CD40L mAb Candidate for Prevention of Kidney Transplant Rejection and Treatment of Autoimmune Diseases

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on TNXP

    February 06, 2025 8:00am EST Download as PDF

    Results from the Phase 1 single ascending dose study support proceeding to develop a Phase 2 trial for the prevention of kidney transplant rejection

    TNX-1500 blocked the primary and secondary antibody responses to a test antigen at the 10 mg/kg and 30 mg/kg i.v. doses

    TNX-1500 showed mean half-life of 34-38 days for the 10 mg/kg and 30 mg/kg doses supporting monthly dosing for future efficacy trials

    TNX-1500 was generally well-tolerated with a favorable safety profile

    Anti-CD40L has multiple potential indications in addition to solid organ and bone marrow transplantation including autoimmune diseases: potential pipeline in a product

    CHATHAM, N.J., Feb. 06, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced positive topline results from its Phase 1, single ascending dose trial of TNX-1500 (Fc-modified humanized anti-CD40L monoclonal antibody, or mAb)* in healthy participants. The objectives of the Phase 1 trial were to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous TNX-1500, as well as to support dosing in a planned Phase 2 trial in kidney transplant recipients.

    “There remains a significant need for new agents with improved activity and safety to prevent transplant rejection and treat autoimmune diseases,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “First generation anti-CD40L mAb therapy, particularly ruplizumab (a.k.a., humanized 5c8 or BG9588) showed activity in modulating autoimmunity and rejection in allo- and xeno-transplantation but was limited by an increased risk of thrombosis.1-3 Tonix created TNX-1500, a next generation anti-CD40L mAb, by reengineering the Fc region of ruplizumab, to preserve activity with improved safety. The results of the Phase 1 study indicate that TNX-1500 has met these design objectives. We believe the results of this study and our prior animal studies4,5 indicate that TNX-1500 is potentially best-in-class among next-generation anti-CD40L mAbs in development.”

    Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals said, “Topline results from the TNX-1500 Phase 1 study showed TNX-1500 at the 10 mg/kg and 30 mg/kg doses blocked both the primary and secondary antibody responses to a test antigen. The pharmacokinetic data support monthly dosing at doses of 10 mg/kg or above. Based on these findings, we are eager to advance this promising candidate into a Phase 2 efficacy study. We believe TNX-1500 has the potential to prevent organ transplant rejection and improve graft survival with reduced long-term toxicity burden relative to current immunosuppressive regimens.”

    Methods and Topline Results

    • Dosing: TNX-1500 solution was infused i.v. over a period of one hour to achieve doses of 3 mg/kg, 10 mg/kg, and 30 mg/kg. Participants were observed in the clinic for one day and followed with periodic clinic visits to Day 120.
    • Keyhole Limpet Hemocyanin (KLH) Challenge: To evaluate the immune modulation potency of TNX-1500, participants received an antigen challenge with KLH (Immucothel®) administered subcutaneously (SC) on Day 2 and Day 29 of the study.
    • Disposition: A total of 26 participants were enrolled in three Cohorts (3 mg/kg, 10 mg/kg, and 30 mg/kg). A total of 24 participants completed the study and two discontinued early (one placebo participant was lost to follow-up and one on TNX-1500 withdrew consent).
    • Tolerability: TNX-1500 was generally well-tolerated with a favorable safety and tolerability profile. The only treatment-emergent adverse event (TEAE) occurring in ≥ 3 participants among all TNX-1500 groups was aphthous ulcer, occurring in one participant each in the 3 mg/kg, 10 mg/kg, and 30 mg/kg groups; all were rated as mild, possibly related, and resolved in 2-10 days. There were no TEAEs assessed as related to KLH administration. No TEAEs led to study discontinuation and there were no serious adverse events. There were no thromboembolic events, which were prespecified as TEAEs of special interest.
    • Pharmacodynamics: TNX-1500 at 10 mg/kg and 30 mg/kg blocked both the primary and secondary anti-KLH Ab responses, evidenced by the mean Ab level at all sampled timepoints (through Day 120) being below the lower limit of quantitation (400 µg/L).  TNX-1500 at 3 mg/kg blocked the primary response to KLH Day 2 challenge and reduced the peak secondary response to KLH Day 29 challenge by approximately two thirds (69%) relative to the peak response to placebo.
    • Pharmacokinetics: The mean (SD) half-life of TNX-1500 was: 3 mg/kg, 19.6 (9.29) days; 10 mg/kg, 37.8 (5.46) days; and 30 mg/kg, 33.7 (4.83) days.

    Tonix plans to discuss these results with the U.S. Food and Drug Administration (FDA) in an End-of-Phase 1 meeting. Pending alignment with the FDA, a Phase 2 study of TNX-1500 in kidney transplant recipients will be pursued.

    About TNX-1500

    TNX-1500 (Fc-modified humanized anti-CD40L mAb) is a humanized monoclonal antibody that binds and functionally inhibits the CD40-ligand (CD40L), also known as CD154. TNX-1500 is being developed for the prevention of allograft and xenograft rejection, for the prevention of graft-versus-host disease (GvHD) after hematopoietic stem cell transplantation (HCT) and for the treatment of autoimmune diseases. Two published articles in the American Journal of Transplantation demonstrate TNX-1500 prevents rejection, prolongs survival and preserves graft function as a single agent or in combination with other drugs in non-human primate renal and heart allografts. 4,5

    *TNX-1500 is an investigational new biologic and is not approved for any indication

    Citations

    1. Lederman S, et al, J Exp Med. 1992;175(4):1091-101. doi: 10.1084/jem.175.4.1091. PMID: 1348081; PMCID: PMC2119166.
    2. Boumpas DT, et. al. Arthritis Rheum. 2003;48(3):719-27. doi: 10.1002/art.10856. PMID: 12632425.
    3. Pierson RN 3rd, et al. Transplantation. 1999;68(11):1800-5. doi: 10.1097/00007890-199912150-00026. PMID: 10609959.
    4. Lassiter G, et al. Am J Transplant. 2023;23(8):1171-1181. doi: 10.1016/j.ajt.2023.03.022.
    5. Miura S, et al. Am J Transplant. 2023;23(8):1182-1193. doi: 10.1016/j.ajt.2023.03.025.

    Tonix Pharmaceuticals Holding Corp.*

    Tonix is a fully-integrated biopharmaceutical company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to advance TNX-102 SL, a product candidate for the management of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing authorization. The FDA has also granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation, and its development is supported by a grant from the U.S. National Institute on Drug Abuse. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in infectious disease, including a vaccine for mpox, TNX-801. Tonix recently announced a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years to develop TNX-4200, small molecule broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.

    * Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.

    Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.

    This press release and further information about Tonix can be found at www.tonixpharma.com.

    Forward Looking Statements

    Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

    Investor Contact

    Jessica Morris
    Tonix Pharmaceuticals
    investor.relations@tonixpharma.com
    (862) 904-8182

    Peter Vozzo
    ICR Healthcare
    peter.vozzo@icrhealthcare.com
    (443) 213-0505

    Media Contact

    Ray Jordan
    Putnam Insights
    ray@putnaminsights.com
    (949) 245-5432

    Indication and Usage

    Zembrace® SymTouch® (sumatriptan succinate) injection (Zembrace) and Tosymra® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.

    Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age.

    Important Safety Information

    Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:

    • discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
    • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
    • pain or discomfort in your arms, back, neck, jaw or stomach
    • shortness of breath with or without chest discomfort
    • breaking out in a cold sweat
    • nausea or vomiting
    • feeling lightheaded

    Zembrace and Tosymra are not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem.

    Do not use Zembrace or Tosymra if you have:

    • history of heart problems
    • narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
    • uncontrolled high blood pressure
    • hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
    • had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
    • severe liver problems
    • taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure.
    • are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
    • an allergy to sumatriptan or any of the components of Zembrace or Tosymra

    Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.

    Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.

    Zembrace and Tosymra may cause serious side effects including:

    • changes in color or sensation in your fingers and toes
    • sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
    • cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
    • increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
    • medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
    • serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
    • hives (itchy bumps); swelling of your tongue, mouth, or throat
    • seizures even in people who have never had seizures before

    The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrance only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only).

    Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider.

    This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633.

    You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

    Primary Logo

    Source: Tonix Pharmaceuticals Holding Corp.

    Released February 6, 2025

    Release – GeoVax Anticipates Significant 2025 Progress with Catalyst-Rich Milestones Across Key Programs

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on GOVX

    Strategic Progress Across COVID-19, Mpox, Oncology Therapies and AI Integration Positions GeoVax for Strong Momentum

    Atlanta, GA – February 5, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today outlined its 2025 strategic milestones and business outlook. Building on a history of delivering on key commitments, GeoVax enters 2025 with a robust pipeline, a catalyst-rich milestone schedule, and an unwavering commitment to addressing unmet medical needs on a global scale.

    An Important Year Ahead for GEO-CM04S1, a Next-Generation COVID-19 Vaccine

    GEO-CM04S1 continues to demonstrate potential for both immunocompromised patients and as a booster vaccine for those previously inoculated with mRNA vaccines. In 2025, the Company anticipates completion of the evaluation trial among Chronic Lymphocytic Leukemia (CLL) patients, a patient population recognized to currently have minimal COVID-19 vaccine options. Interim data reported in Q4 2024 suggest GEO-CM04S1 may offer superior immune responses to CLL patients compared to an mRNA vaccine.

    GeoVax also expects to report final results from its healthy adults booster trial, offering valuable data on the vaccine’s safety and immunogenicity profile. Another pivotal milestone for GEO-CM04S1 in 2025 is the anticipated initiation of patient enrollment in the BARDA-funded Project NextGen Phase 2b trial, which will evaluate GEO-CM04S1 compared to an authorized mRNA vaccine within a 10,000-patient study. As both a booster and a primary vaccine for immune-compromised patient populations, GEO-CM04S1 remains central to GeoVax’s mission to address the ongoing and evolving challenges of COVID-19.

    As part of its strategy, GeoVax will continue to explore and establish strategic partnerships and collaborations to accelerate the development, commercialization, and global accessibility of GEO-CM04S1.

    GEO-MVA: Addressing Biosecurity and Global Health Gaps

    GEO-MVA, a vaccine designed to combat Mpox and Smallpox, has emerged as a critical solution amid rising global biosecurity concerns. In 2025, the Company plans to initiate clinical evaluations for GEO-MVA while continuing discussions with various stakeholders regarding the opportunity to utilize GEO-MVA among underserved populations in regions including Africa. With ongoing geopolitical and logistical challenges limiting vaccine availability, GEO-MVA’s ability to offer multi-disease protection, minimal refrigeration needs, and scalability through implementation of an advanced MVA manufacturing process, GEO-MVA represents a potential transformative resource for both national biosecurity strategies and global health initiatives.

    GeoVax recognizes that addressing these critical global challenges requires collaborative efforts. In 2025, the Company will actively pursue strategic partnerships with governments, NGOs, and private-sector stakeholders to maximize the impact and reach of its GEO-MVA platform.

    Gedeptin: Unlocking Potential in Solid Tumor Cancer Therapy

    GeoVax’s oncology program, centered around Gedeptin®, continues to progress in addressing unmet medical needs in solid tumor therapies. Following encouraging results from Phase 1 and Phase 1/2 trials, Gedeptin is advancing into a Phase 2 clinical trial in 2025, where it will be evaluated in combination with an immune checkpoint inhibitor, targeting first recurrent head and neck cancer. This trial aims to validate the potential synergy between Gedeptin’s targeted gene-directed enzyme prodrug therapy and the powerful immune responses activated by checkpoint inhibitors.

    As an FDA-designated Orphan Drug for anatomically accessible oral and pharyngeal cancers, Gedeptin is strategically positioned to address not only head and neck cancers but also other solid tumor indications, such as triple-negative breast cancer, soft tissue sarcoma and melanoma. GeoVax’s clinical roadmap for Gedeptin represents a significant market opportunity, with the potential to reshape how these cancers are treated worldwide.

    GeoVax remains open to collaborations with oncology leaders, academic research institutions, and industry partners to further enhance the clinical impact and commercial success of Gedeptin.

    Next-Generation Manufacturing: Pioneering Scalable Vaccine Production

    To amplify the value of its clinical programs, GeoVax is also focused on advancing MVA vaccine manufacturing through validation of continuous cell line manufacturing processes, ensuring consistent, high-quality vaccine production capabilities. These advancements address long-standing challenges in vaccine scalability and cost-effectiveness, positioning GeoVax as a leader in MVA-based vaccine manufacturing solutions, potentially implementing a proprietary MVA manufacturing process supporting more flexible, localized MVA manufacturing at lower production cost, specifically enabling vaccine self-sufficiency manufacturing in low-middle income regions such as Africa.

    GeoVax recognizes that strong manufacturing partnerships are vital to bringing these innovations to market efficiently and cost-effectively. The Company plans to collaborate with manufacturing partners worldwide to scale up production capabilities and meet the growing global demand for MVA-based vaccines.

    AI Integration: Optimizing Processes and Driving Innovation

    In alignment with its 2025 objectives, GeoVax has expanded the integration of Artificial Intelligence (AI) across its vaccine development and cancer immunotherapy activities. Leveraging AI is anticipated to accelerate vaccine development, optimize cancer therapies, streamline clinical trials, and enhance manufacturing processes, potentially in the following manners:

    • Vaccine and Therapy Innovation: Predicting pathogen mutations and optimizing GEO-CM04S1 and Gedeptin® design, ensuring effectiveness in variant-proof vaccines and cancer therapies.
    • Clinical Trial Optimization: Refining patient selection, accelerating recruitment, and enhancing diversity for trials targeting high-risk and underserved populations.
    • Streamlined Manufacturing: Enhancing scalability and logistics, enabling efficient production and distribution, particularly in underserved regions.

    Addressing a $55+ Billion Pipeline Market Opportunity

    GeoVax’s pipeline addresses significant unmet and underserved medical needs worldwide in both infectious disease vaccines and oncology, representing a collective potential global market opportunity in excess of $55 billion. Each program—GEO-CM04S1, GEO-MVA, and Gedeptin—addresses significant gaps in existing treatment and prevention strategies, backed by emerging clinical data and a focus towards achieving the necessary regulatory milestones in support of product registration.

    David Dodd, Chairman & CEO of GeoVax, commented: “2024 was a transformative year for GeoVax, and our focus and commitment in 2025 is unwavering, focused on critically needed unmet medical needs. Our pipeline, enriched with value-driven milestones, positions us well for successful growth and development.  Collaborations and partnerships remain core to our strategy, ensuring our innovations reach those who need them most. With GEO-CM04S1, GEO-MVA, Gedeptin, our MVA manufacturing advancements, and leveraging AI to optimize our processes and drive innovation, we are prepared to make meaningful contributions to global health, delivering value to our fellow shareholders, various stakeholders and, providing compelling career development opportunities to our staff colleagues.”

    For further details on GeoVax’s pipeline and strategic initiatives, please visit www.geovax.com.

    About GeoVax

    GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines for many of the world’s most threatening infectious diseases and therapies for solid tumor cancers. The company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine for which GeoVax was recently awarded a BARDA-funded contract to sponsor a 10,000-participant Phase 2b clinical trial to evaluate the efficacy of GEO-CM04S1 versus an approved COVID-19 vaccine. In addition, GEO-CM04S1 is currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. A Phase 2 clinical trial in first recurrent head and neck cancer, evaluating Gedeptin® combined with an immune checkpoint inhibitor is planned to initiate during the first half of 2025. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. The Company has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.

    Forward-Looking Statements

    This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

    Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. 

    Company Contact: Investor Relations Contact:                      Media Contact:
    info@geovax.com                     austin.murtagh@precisionaq.com sr@roberts-communications.com 
    678-384-7220 212-698-8696 202-779-0929

    Release – PDS Biotech Reaffirms Guidance for First Quarter Initiation of VERSATILE-003 Phase 3 Clinical Trial in HPV16-Positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on PDSB

    FDA-cleared amended trial design; First site initiation expected Q1 2025

    PRINCETON, N.J., Feb. 05, 2025 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, today reaffirmed the Company’s guidance of initiating its VERSATILE-003 Phase 3 clinical trial of Versamune® HPV plus pembrolizumab for first-line treatment of recurrent and/or metastatic (R/M) HPV16-positive head and neck squamous cell cancer (HNSCC) in the first quarter of this year.

    PDS Biotech submitted its updated clinical protocol on November 15, 2024, amending the Investigational New Drug (IND) application. The window for comments from the U.S. Food and Drug Administration (FDA) has passed, and the Company is on track to initiate site activation in the first quarter of 2025. The Company has received Fast Track designation from the FDA for the combination of Versamune® HPV and pembrolizumab in R/M HNSCC. (See VERSATILE-002 Phase 2 clinical results here.)

    “The integral elements for trial initiation are ready, including alignment with the FDA,” said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. “We look forward to initiating VERSATILE-003 this quarter and advancing the combination of Versamune® HPV plus pembrolizumab to potentially provide improved outcomes for patients with HPV16-positive R/M HNSCC.”

    HPV16-positive patients represent a large, fast-growing subgroup in need of targeted therapies to treat the underlying cause of the cancer. A recently validated companion diagnostic to confirm HPV16-positive HNSCC will be utilized during the patient screening process of the VERSATILE-003 trial.

    “HPV16-positive HNSCC is poised to become the dominant type of HNSCC in the US and EU,” said Kirk Shepard, M.D., PDS Biotech’s Chief Medical Officer. “Confirming HPV16 status with a potentially commercializable test is essential to effectively identifying the patients suitable to receive Versamune HPV. This will be the first investigational use of this type of companion diagnostic in a Phase 3 clinical trial in HNSCC.”

    For more information on VERSATILE-003, visit ClinicalTrials.gov (Identifier: NCT06790966).

    About PDS Biotechnology
    PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers. The Company plans to initiate a pivotal clinical trial to advance its lead program in advanced HPV16-positive head and neck squamous cell cancers. PDS Biotech’s lead investigational T-cell stimulating immunotherapy Versamune® HPV is being developed in combination with a standard-of-care immune checkpoint inhibitor, and also in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate (ADC), and a standard-of-care immune checkpoint inhibitor.

    For more information, please visit www.pdsbiotech.com

    Forward Looking Statements
    This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for Versamune® HPV, PDS01ADC and other Versamune® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning Versamune® HPV, PDS01ADC and other Versamune® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the Company’s ability to continue as a going concern; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.  

    Versamune® is a registered trademark of PDS Biotechnology Corporation.

    Investor Contact:
    Mike Moyer
    LifeSci Advisors
    Phone +1 (617) 308-4306
    Email: mmoyer@lifesciadvisors.com

    Media Contact:
    Janine McCargo
    6 Degrees
    Phone +1 (646) 528-4034
    Email: jmccargo@6degreespr.com

    Teladoc Health to Acquire Catapult Health, Expanding Preventive and At-Home Care Offerings

    Posted on by cpatches
    Key Points:
    – Teladoc Health is acquiring Catapult Health for $65 million to enhance its preventive care and at-home diagnostic testing capabilities, further strengthening its integrated healthcare solutions.
    – Catapult Health’s VirtualCheckup program will enable Teladoc to expand its chronic condition management services and seamlessly connect high-risk patients to virtual care programs.
    – This acquisition comes as Teladoc seeks to regain momentum following its 2020 Livongo acquisition, which initially valued the combined company at $37 billion but has since declined to a market cap under $2 billion.

    Teladoc Health has announced a definitive agreement to acquire Catapult Health, a move aimed at strengthening its preventive care and chronic condition management capabilities while expanding its at-home diagnostic testing offerings. This acquisition aligns with Teladoc’s strategy to enhance virtual care accessibility and effectiveness for its over 93 million members.

    Catapult Health is recognized for its innovative approach to at-home wellness and diagnostic testing, which integrates virtual clinical support and high-touch patient engagement. Teladoc plans to leverage these capabilities to further enrich its industry-leading suite of integrated healthcare solutions.

    “This acquisition will help advance our strategy in meaningful ways — from giving more members access to convenient and impactful wellness and preventive care, to unlocking greater value for our customers,” said Chuck Divita, Chief Executive Officer of Teladoc Health. “Catapult Health brings an experienced team and a strong culture of innovation, and we are thrilled to welcome them to Teladoc Health.”

    Strategic Objectives and Synergies

    Teladoc Health’s integrated care strategy is built on four key pillars:

    • Expanding Membership and Service Utilization – Enhancing the accessibility and engagement of healthcare services for existing and new members.
    • Leveraging Clinical Expertise and Product Breadth – Strengthening healthcare outcomes by integrating a broader range of clinical solutions.
    • Growing International Presence – Extending Teladoc’s reach beyond domestic markets to serve a global population.
    • Advancing Mental Health Solutions – Building upon its existing leadership in virtual mental health services.

    Catapult Health’s flagship VirtualCheckup program exemplifies its innovation in preventive care. The at-home wellness exam provides members with a simple diagnostic kit, allowing them to collect blood samples, measure blood pressure, and submit other key health data. Following this, a virtual consultation with a licensed healthcare professional ensures timely assessment and guidance.

    For members identified with high-risk factors or chronic conditions, Catapult’s clinicians can seamlessly enroll them into Teladoc’s condition management programs, including diabetes, hypertension, pre-diabetes, and weight management. Additionally, members can be referred to Teladoc’s virtual mental health specialists and primary care providers for continued support.

    Transaction Details

    The acquisition is structured as an all-cash transaction valued at $65 million, with up to $5 million in contingent earnout consideration. Catapult Health reported $30 million in trailing 12-month revenue as of Q3 2024. Upon closing, Catapult will be integrated into Teladoc’s Integrated Care segment. The deal is expected to close in Q1 2025.

    Impact and Market Expansion

    Catapult Health currently serves over 3 million people through its partnerships with hundreds of employer clients. The company is recognized for its strong customer satisfaction, clinical outcomes, and cost-saving benefits, including an estimated $1,400 average savings per participant over a three-year period due to early disease detection and health risk identification.

    Teladoc’s Market Challenges and Context

    This acquisition comes after a tumultuous period for Teladoc. Following its acquisition of Livongo in 2020, the combined companies had an enterprise value of $37 billion. However, Teladoc’s stock has struggled since then, with a current market capitalization just under $2 billion. The acquisition of Catapult Health represents a strategic effort to regain momentum and strengthen its position in the evolving telehealth market.