Tag: Biotechnology

Release – Eledon Pharmaceuticals Appoints Kidney Transplant Specialist Dr. Allan Douglas Kirk to Board of Directors

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Research News and Market Data on ELDN

IRVINE, Calif., Oct. 02, 2023 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced the appointment of Allan Douglas Kirk, M.D., Ph.D., to its Board of Directors. Dr. Kirk is internationally recognized for his work in organ transplantation, with a specialized focus on kidney transplants and transplant immunology. He is currently Chairman of the Department of Surgery and Surgeon-in-Chief at Duke University School of Medicine. He is also the David C. Sabiston, Jr. Professor of Surgery, a Professor of Integrative Immunobiology, and a Professor of Pediatrics at Duke.

“We are pleased to have Dr. Kirk join our Board of Directors at a pivotal time at the company following initiation of our Phase 2 BESTOW trial evaluating tegoprubart for the prevention of organ rejection in patients receiving a kidney transplant,” said David-Alexandre C. Gros, M.D., Eledon Chief Executive Officer. “Dr. Kirk’s renowned expertise in the field of organ transplantation, including kidney transplantation, will be incredibly valuable as we advance tegoprubart in clinical development on our mission to fulfill an urgent unmet need for the thousands of patients in need of an organ transplant. I look forward to working closely together.”

“Organ transplantation remains an area of significant unmet need – a need that is often overlooked or underrecognized – and my decades of research have been driven by my desire to improve immunosuppression regimens for transplant patients. Transplant recipients deserve new treatment options with better efficacy and fewer side-effects to help protect their transplanted organs,” said Dr. Kirk. “I am proud to join the Eledon team on their mission to bring patients a novel treatment option that has the potential to transform immunosuppression and improve the lives of patients.”

Dr. Kirk served as the inaugural Chief of the Transplantation Branch for the National Institute of Diabetes and Digestive and Kidney Diseases and has been a principal investigator for multiple clinical trials, including the first-in-human experience with novel immunosuppressive agents. Dr. Kirk has helped pioneer the use of co-stimulation pathway blockade to prevent organ rejection in transplant patients. He has a special interest in immune management of transplant recipients, including therapies that influence T cell co-stimulation pathways and adjuvant therapies that facilitate co-stimulation blockade to prevent the rejection of transplanted organs without undue suppression of protective immunity. His research is directed toward understanding transplant rejection and translating this understanding into improved therapies for transplant recipients. He has co-authored hundreds of peer-reviewed journal publications.

Dr. Kirk is a member of the Duke Transplant Center and is a core faculty member of the Duke Innovation & Entrepreneurship program. He also previously served as Editor-in-Chief for the American Journal of Transplantation. Dr. Kirk earned an M.D. from Duke University School of Medicine, a Ph.D. from Duke University and a B.S. from Old Dominion University.

About Eledon Pharmaceuticals and tegoprubart (formerly AT-1501)

Eledon Pharmaceuticals is a clinical stage biotechnology company with immunology expertise that is developing therapies to protect and prevent rejection of transplanted organs, as well as to treat amyotrophic lateral sclerosis (ALS). The Company’s lead compound in development is tegoprubart, an anti-CD40L antibody with high affinity for CD40 Ligand (also called “CD154”), a well-validated biological target with broad therapeutic potential. 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 planned clinical trials and the Company’s other future expectations, plans and prospects, 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 sides, 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
[email protected]

Media Contact:

Jenna Urban
Berry & Company Public Relations
(212) 253 8881
[email protected]

Source: Eledon Pharmaceuticals

Cocrystal Pharma (COCP) – CDI-988 Begins Phase 1a/b Clinical Trial

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Monday, October 02, 2023

Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

CDI-988 Begins Clinical Studies. Cocrystal announced that CDI-988 has begun Phase 1a/b studies, meeting our expected timeframe. CDI-988 is a 3CL protease inhibitor that interferes with an enzyme early in the viral lifecycle, stopping a virus from reproducing. This early action contrasts with other approaches that seek to kill the virus after it reaches the bloodstream. The study objective is to establish safety, dosing, and pharmacokinetics for design of a Phase 2 study.

Phase 1a/b Study Will Test Ascending Dose Cohorts. The study will have a Phase 1a single ascending-dose stage (SAD) in which patients receive a single administration of CDI-988. As safety is established for each dose, subsequent groups receive higher doses. The Phase 1b stage will have multiple administrations of CDI-988 at ascending doses (MAD). Since CDI-988 is an orally administered vaccine, pharmacokinetic data will include the effect of food drug adsorption. The results of the study will be used to design Phase 2 studies in both norovirus, a frequent cause of acute gastroenteritis, and COVID-19.


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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Baudax Bio (BXRX) – Orphan Drug Designation Granted By FDA for TI-168

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Friday, September 29, 2023

Baudax Bio is a pharmaceutical company focused on innovative products for acute care settings. ANJESO is the first and only 24-hour, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain. In addition to ANJESO, Baudax Bio has a pipeline of other innovative pharmaceutical assets including two novel neuromuscular blocking agents (NMBs) and a proprietary chemical reversal agent specific to these NMBs. For more information, please visit www.baudaxbio.com.

Gregory Aurand, Senior Vice President, Equity Research Analyst, Healthcare Services & Medical Devices, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Treatment of Hemophilia A with inhibitors.  As announced yesterday, the FDA granted Orphan Drug Designation to the Company’s novel treatment. TI-168 is the IND-cleared Treg therapy to address Factor VIII (FVIII) inhibitors in Hemophilia A patients.  Baudax Bio expects to initiate Phase 1/2a trial enrollment early 2024.

Important FDA acknowledgement.  The FDA has authority to grant orphan drug status for new treatments in rare diseases affecting fewer than 200,000 patients in the United States.  The designation qualifies sponsoring companies with qualified clinical trial tax credits, exemption from user fees, potential seven years of market exclusivity after approval, and other benefits. It is estimated that 105,000-165,000 Hemophilia A patients are affected with autoantibody inhibitors in the U.S.


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Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Release – Baudax Bio Announces Orphan Drug Designation Granted by U.S. FDA for TI-168 for the Treatment of Hemophilia A with Inhibitors

Posted on by [email protected]

Research News and Market Data on BXRX

September 28, 2023 8:00am EDT

MALVERN, Pa., Sept. 28, 2023 (GLOBE NEWSWIRE) — Baudax Bio, Inc. (the “Company” or “Baudax Bio”) (NASDAQ: BXRX), a biotechnology company focused on developing T cell receptor (“TCR”) therapies utilizing human regulatory T cells (“Tregs”), as well as a portfolio of clinical stage Neuromuscular Blocking Agents (“NMBs”) and an associated reversal agent, today announced that U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its lead clinical candidate TI-168 for the treatment of Hemophilia A with inhibitors. TI-168 is the Company’s next-generation, FVIII specific Treg therapy designed to reliably and effectively address Hemophilia A patients with FVIII inhibitors.

“We are very pleased with the FDA’s decision to grant orphan drug designation to TI-168, which we believe highlights the urgent need for innovation and new therapeutic options for Hemophilia A patients,” said Gerri Henwood, President and Chief Executive Officer of Baudax Bio. “We believe this is an important therapeutic area, with established preclinical proof of concept in TI-168 through successes observed in Hemophilia A with inhibitors in animal models. With an Investigational New Drug (IND) application already FDA-cleared, we believe we can activate the Phase 1/2a Clinical Trial of TI-168 for Treatment of hemophilia A with inhibitors with a modest initial budget, and advance this therapy to further clinical investigation in early 2024.”

The FDA’s Office of Orphan Products Development grants orphan status to drugs being developed to treat, diagnose, or prevent a rare disease or condition affecting fewer than 200,000 people in the United States. Orphan Drug Designation is designed to provide drug developers with various benefits to support the development of novel drugs, including the potential for market exclusivity for seven years upon FDA approval, eligibility for tax credits for qualified clinical trials, waiver of application fees, reduced annual product fees, clinical protocol assistance and potential qualification for expedited development programs.

About Baudax Bio

Baudax Bio is a biotech company focused on innovative products for certain auto-immune conditions, of which many but not all, are orphan drug conditions as well as acute care and related settings. The combined company will further the development of Treg therapy specific to HA (pipeline candidate TI-168). TI-168 is a next-generation, FVIII specific Treg therapy designed to reliably and effectively address Hemophilia A patients with FVIII inhibitor. By combining the patented Treg culture method and TeraImmune designed FVIII-specific TCR, the Company has successfully demonstrated the therapeutic concept of FVIII TCR-Treg therapy in controlling of FVIII ADA in a hemophilic animal model. The lead program TI-168 has shown encouraging pre-clinical data and the FDA has cleared an IND to commence a Phase 1/2a clinical trial for the treatment of Hemophilia A with inhibitors.

In addition, over time, the combined company will advance the development of TeraImmune’s innovative immune-cell therapies, leveraging a dual Treg manufacturing platform consisting of both natural regulatory Tregs isolated from patients and induced Tregs converted from a patient’s T-effector (“Teff”) cells. This Treg platform technology is designed for conditions that suppress unwanted immune reactions and includes the allogenic, or off-the-shelf, Tregs obtained from Umbilical Cord Blood for the treatment of skin diseases such as Atopic Dermatitis. For more information, please visit www.baudaxbio.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements reflect Baudax Bio’s expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words “anticipate,” “believe,” “estimate,” “may,” “upcoming,” “plan,” “target,” “goal,” “intend,” and “expect,” and similar expressions, as they relate to Baudax Bio, are intended to identify such forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on Baudax Bio’s current beliefs, expectations and assumptions regarding the future of its business, future plans and strategies, clinical results and other future conditions. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to those set forth under the caption “Risk Factors” in Baudax Bio’s most recent Annual Report on Form 10-K filed with the SEC and its subsequent filings with the SEC. Any forward looking statement speaks only as of the date on which it was made. Neither Baudax Bio, nor any of its affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing Baudax Bio’s views as of any date subsequent to the date hereof.

Investor Relations Contact:

Mike Moyer
LifeSci Advisors
[email protected]

Source: Baudax Bio

Released September 28, 2023

Eledon Pharmaceuticals (ELDN) – Initiating Coverage With An Outperform Rating and $10 Price Target

Posted on by [email protected]


Wednesday, September 27, 2023

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

We Are Initiating Coverage Of EledonPharmaceuticals. Eledon is developing tegoprubart, an anti-CD40L antibody to modulate the immune response. Phase 1b and Phase 2 clinical trials in progress for prevention of kidney transplant rejection. The clinical trial program is designed to show superiority to the immunosuppressive drugs that are currently the standard of care after organ transplants.

Tegoprubart Blocks CD40/CD40L. Tegoprubart blocks the step in the immune response where the CD40 ligand (CD40L, also known as CD154) on T cells interacts with the CD40 receptor on either B cells or antigen-presenting cells. This binding connects the innate and adaptive immune systems and leads to a full immune response. Tegoprubart binds to the CD40L to block this step, inhibiting both B cell maturation and T-cell proliferation that leads to cellular immune responses.


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Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Alfasigma Makes Big Bet on Liver Disease With $1.25 Billion Intercept Buyout

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Italian pharma Alfasigma is expanding its gastroenterology portfolio in a major way with the proposed $1.25 billion acquisition of Intercept Pharmaceuticals. The all-cash deal provides Alfasigma with Intercept’s leading drug Ocaliva and a strengthened pipeline in progressive liver diseases.

Alfasigma will pay $19 per share to acquire Intercept, representing an 82% premium over Intercept’s share price before the deal announcement. The purchase price reflects a big bet on Ocaliva’s growth prospects and Intercept’s broader capabilities in rare liver conditions.

Ocaliva is the key asset Alfasigma gains from the deal. It’s the only FDA approved second-line treatment for primary biliary cholangitis (PBC), a progressive autoimmune disorder that damages the bile ducts in the liver. Ocaliva hit $152 million in sales over the first half of 2023 alone, underscoring its rapid growth trajectory.

Beyond Ocaliva, Alfasigma also adds Intercept’s emerging pipeline of novel therapies for PBC and other liver diseases. The crown jewel is a promising fixed-dose combination regimen that could transform the PBC treatment paradigm.

Take a look at Noble Capital Markets Senior Life Sciences Analyst Robert LeBoyer’s coverage universe.

The deal dramatically expands Alfasigma’s presence in the high-value U.S. pharma market. Previously focused primarily on the Italian market, the Intercept acquisition gives Alfasigma an anchor asset and commercial team in the U.S.

Strategically, the move aligns with Alfasigma’s vision to build up its gastroenterology and hepatology business. CEO Francesco Balestrieri highlighted Intercept’s compelling strategic fit with Alfasigma’s focus in these therapeutic areas.

Expect Alfasigma to invest heavily to maximize Ocaliva’s potential. The company sees major commercial expansion opportunities to extend Ocaliva’s reach across PBC patient populations. Alfasigma also gains Intercept’s seasoned specialty sales force to drive prescription growth.

With Intercept operating as a wholly-owned subsidiary once the buyout closes, Alfasigma is well-positioned to become a global force in progressive liver diseases. The deal enhances Alfasigma’s standing as an emerging player in the U.S. pharma market.

Look for Alfasigma to continue seeking acquisition targets to accelerate its growth. The company has the financial firepower to pursue additional deals that build up its portfolio. If the Intercept acquisition is any indication, Alfasigma has appetite for bold, transformative M&A.

The proposed buyout still requires regulatory and shareholder approval. But with a massive 82% premium offered, Intercept shareholders are likely to approve the $19 per share deal price. Expect Alfasigma to move rapidly to complete the acquisition by the end of 2023.

Soleno Therapeutics Stock Skyrockets 505% on Hunger Pill Promise

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Shares of Soleno Therapeutics (SLNO) catapulted an astonishing 505% higher last week after positive late-stage clinical results for the company’s experimental obesity and hunger control pill. The massive stock surge demonstrates investor enthusiasm around Soleno’s DCCR pill as a potential new medicine for Prader-Willi syndrome (PWS).

DCCR aims to treat hyperphagia, or abnormally increased hunger and food drive, in patients with PWS. The rare genetic disorder can lead to excessive eating, obesity, and other complications. Soleno’s pill showed promising ability to control hunger signals in PWS patients during a 4-month placebo-controlled withdrawal study.

The trial enrolled 77 PWS patients who had been taking DCCR for 2-4 years. Half the participants continued their DCCR regimen, while the other half were switched to placebo. After just one month, the placebo group showed a rapid return of hyperphagia symptoms. On a 9-point clinical scale, their hunger scores increased by a significant 5 points on average.

In contrast, PWS patients who remained on DCCR maintained stable, controlled hunger levels throughout the 4-month trial. The results provide strong evidence that DCCR specifically curbs abnormal hunger drive in PWS, rather than just having a placebo effect.

Beyond hunger control, PWS patients taking placebo also showed worsening in overall PWS symptoms and severity. No new safety issues emerged during the 4 months on placebo, indicating the hunger control benefits of DCCR remained after stopping treatment.

Armed with the successful phase 3 results, Soleno now plans to submit a New Drug Application for DCCR to the FDA in mid-2024. The company is seeking an initial approval in PWS, which would make DCCR the first ever pharmacotherapy for hyperphagia associated with the condition.

The FDA previously designated DCCR an Orphan Drug for treating PWS. This status provides incentives to develop medicines for rare diseases, since PWS affects only about 15,000-16,000 individuals in the U.S. The new trial results could support approval based on the FDA’s prior guidance.

If greenlighted, analysts project DCCR peak sales could reach $500 million – $1 billion annually. The pill would provide a novel, non-surgical therapeutic option to manage hyperphagia and obesity in PWS. DCCR’s unique clinical benefits could command premium pricing above $100,000 per patient annually.

Soleno still has work ahead to realize commercialization, including securing FDA approval and payer coverage. But the company now has a de-risked late stage asset and clear regulatory path forward. The 505% share price spike last week reflects renewed investor confidence in DCCR’s commercial potential.

Despite the rally, Soleno still trades 70% below its 2018 highs. The stock has suffered from past clinical setbacks that stoked skepticism around DCCR. But with a successful phase 3 trial now completed, the tide may be turning.

Soleno could seek to expand DCCR’s use into additional patient populations with uncontrolled hunger and obesity issues beyond PWS. The pill works by modulating metabolic pathways that drive hyperphagia symptoms.

While gains may moderate going forward, last week’s huge rally kicks off a new chapter for Soleno stock. Look for the company to shift focus from pivotal trial execution to commercial planning. Investors cheered the pivotal data, signaling confidence in DCCR’s prospects. Soleno still has work left to turn its hunger-controlling pill into an FDA-approved medicine, but the 505% surge shows just how much upside investors anticipate.

Release – Tonix Pharmaceuticals Announces Initiation of Enrollment in the MGH Phase 2 ‘POWER’ Study of TNX-1900 (Intranasal Potentiated Oxytocin) for the Treatment of Pediatric Obesity

Release – GeoVax Secures Multi-Product License for ProBioGen’s AGE1.CR.pIX® Suspension Cell Line to Bolster MVA-Based Vaccine Development

Posted on by [email protected]

Research News and Market Data on GOVX

ATLANTA, GA and BERLIN, Germany, September 26, 2023 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing vaccines and immunotherapies against infectious diseases and cancers, and ProBioGen announce the signing of a landmark commercial license agreement for ProBioGen’s groundbreaking AGE1.CR.pIX® suspension cell line. The agreement will empower GeoVax to enhance the manufacturing capabilities of its entire Modified Vaccinia Ankara (MVA) based vaccine portfolio.

ProBioGen’s AGE1.CR.pIX suspension cell line is an innovative and proven platform that enables high-yield and scalable production, ensuring efficient industrial manufacturing processes. This translates to cost-effectiveness and increased productivity for vaccine developers. The AGE1.CR.pIX cell line’s versatility allows it to support a wide range of viruses and vaccine types, enhancing its suitability for various vaccines in development and as a replacement for traditional production systems. Additionally, AGE1.CR.pIX’s robust growth and genetic stability ensure consistent and reliable production, leading to the delivery of safe and effective vaccines. MVA grows particularly well on this cell line, making it even more advantageous for vaccine development. By leveraging this modern production technology, GeoVax aims to accelerate the manufacturing of its entire vaccine pipeline. This multi-product license represents a strong commitment to improving global access to life-saving vaccines.

“We are thrilled to enter into this licensing agreement with ProBioGen”, said David Dodd, Chairman & CEO of GeoVax. “The AGE1.CR.pIX suspension Cell Line is a game-changer for our vaccine production, allowing us to streamline our manufacturing processes while maintaining the highest quality standards. Development of a high-yield, high-capacity process to produce MVA-based vaccines and immunotherapies is nothing short of transformational, and by advancing our MVA manufacturing to a modern, interchangeable process, we are on course to expand MVA applications from stockpile-based solutions for niche medical markets to respond to world needs on a timely basis, whenever and wherever they arise. This partnership with ProBioGen aligns perfectly with GeoVax’s mission of developing safe and effective vaccines to protect public health.”

“ProBioGen is equally excited about the collaboration, recognizing the potential impact of their technology on global health. GeoVax, as one of the key MVA companies, will strengthen its innovative vaccines with the benefit of a straightforward manufacturing solution”, said Dr. Volker Sandig, CSO of ProBioGen. “We believe this partnership will significantly contribute to GeoVax’s ability to accelerate vaccine production and distribution, ultimately benefiting communities worldwide.”

Financial terms of the commercial license to use the AGE1.CR.pIX, including potential clinical milestones and future royalties were not disclosed.

About ProBioGen

ProBioGen is a premiere, Berlin-based specialist for developing and manufacturing biopharmaceutical active ingredients, viral vectors and vaccines with applying proprietary technologies to improve product quality and features. Combining both state-of-the-art development services, together with intelligent product-specific technologies yields biologics with optimized properties. Rapid and integrated cell line and process development, comprehensive analytical development and GMP-compliant manufacturing is performed by a highly skilled and experienced team. All services and technologies are embedded in a total quality management system to assure compliance with international ISO and GMP standards (EMA/FDA).

ProBioGen has been operational for almost 30 years. At three locations in Berlin, over 300 employees contribute to the creation of new therapies in medicine and groundbreaking innovations worldwide through their creative and meticulous work. ProBioGen’s growth strategy is driven by the expansion of the service value chain through organic growth and potential acquisition. Diversification is a complement driver, while the focus is strict on enabling the development of biopharmaceuticals for tomorrow.

ProBioGen’s AGE1.CR.pIX cell line is derived from primary cells of a duck embryo and was designed to comply with health authority guidelines and the concept of “defined risk”. It was developed as an alternative to the use of chicken eggs for large-scale vaccine production. The AGE1.CR.pIX cell line grows in true suspension and has been optimized for viral vaccine production and stability. It grows in a commercially available, chemically defined medium without animal components and is an excellent host for a variety of different virus strains.

For more information about ProBioGen, follow us on LinkedIn.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as 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, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades.

GeoVax 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.

ProBioGen Contact:         ProBioGen Press Contact:
Dr. Gabriele SchneiderLisa Petereit
Chief Business Officer Corporate Communications
[email protected] [email protected]
   
   
GeoVax Contact: GeoVax Press Contact:
[email protected]  Susan Roberts
678-384-7220 [email protected]
  202-779-0929

Regeneron Strengthens Gene Therapy Pipeline Through Acquisition of Decibel Therapeutics

Posted on by [email protected]

Regeneron Pharmaceuticals has expanded its gene therapy programs by acquiring Decibel Therapeutics, a biotech company focused on developing treatments for hearing loss. The $1.1 billion deal provides Regeneron with three promising gene therapy candidates that use adeno-associated virus (AAV) vectors to restore hearing.

The most advanced asset is DB-OTO, an AAV-based gene therapy designed to provide long-term hearing to individuals with profound congenital hearing loss caused by otoferlin gene mutations. DB-OTO is currently being evaluated in a Phase 1/2 clinical trial known as CHORD. The gene therapy aims to deliver a functional copy of the otoferlin gene to inner ear hair cells, potentially enabling hearing restoration.

The acquisition also includes two earlier-stage gene therapies, AAV.103 and AAV.104, targeting other genetic forms of hearing loss – GJB2 and STRC respectively. Both utilize a similar AAV gene delivery approach to DB-OTO.

According to Regeneron, the addition of Decibel’s pipeline and capabilities will strengthen its genetic medicines portfolio. Gene therapy has become a major focus for Regeneron beyond its foundational expertise in antibodies. The company is exploring gene silencing, gene editing and gene therapy technologies across a range of therapeutic areas.

Take a look at Ocugen Inc., a biotechnology company focused on discovering, developing and commercializing novel gene and cell therapies and vaccines.

Hearing loss represents a new area for Regeneron, building on an existing collaboration with Decibel. Integration of Decibel’s team and experience in inner ear biology and AAV gene therapy for hearing disorders will be invaluable as Regeneron advances the acquired programs.

Gene therapy aims to address disease at its genetic root cause by introducing functional genes into cells. The goal is to durably restore protein expression and correct the downstream impacts of gene mutations. Gene therapy has shown promise for treating rare monogenic disorders like certain forms of inherited hearing loss.

Both Regeneron and Decibel have utilized AAV vectors to deliver gene therapy payloads. AAV is considered one of the most effective vehicles for gene delivery and has an established safety profile. The viruses can be engineered to target specific cell types following injection into the body.

For DB-OTO, the AAV vector carries a functional copy of the otoferlin gene. Inner ear hair cells are the targets for gene transduction. Otoferlin protein is critical for hearing signal transduction, but mutations in the encoding gene cause profound congenital deafness. Gene therapy aims to restore otoferlin expression and regain hearing function.

Regeneron’s push into gene therapy aligns with its mission of tackling serious diseases with novel technologies. Gene-based treatments have potential for one-time curative therapies. The acquisition of Decibel’s pipeline further diversifies Regeneron’s genetic medicine capabilities as it aims to help patients worldwide.

Release – Eledon Pharmaceuticals Announces Use of Tegoprubart anti-CD40L Antibody in Second-ever Transplant of Genetically Modified Heart from a Pig to a Human

Posted on by [email protected]

Research News and Market Data on ELDN

Landmark cardiac xenotransplantation procedure conducted at University of Maryland Medical Center

Tegoprubart, administered investigationally to prevent organ rejection post-transplant, targets the CD40L pathway known to play an essential role in both innate and adaptive immune cell activation and function.

IRVINE, Calif., Sept. 25, 2023 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced that tegoprubart, the company’s investigational anti-CD40 antibody, was used as a cornerstone component of the chronic immunosuppressive regimen administered following the second-ever transplant of a genetically modified heart from a pig to a human. The procedure was completed on September 20th at University of Maryland Medical Center on a 58-year-old male suffering from heart failure.

“This is a momentous milestone for the transplant community and serves as a testament to the continued progress being made towards advancing novel treatment options for patients requiring an organ transplant,” said David-Alexandre C. Gros, M.D., Eledon Chief Executive Officer. “As the field of organ transplantation continues to make important scientific advances, Eledon is dedicated to delivering a novel immunosuppressive regimen with the potential to protect and prevent rejection of transplanted organs, and we are honored to play a role in this historic development.”

Following the successful transplantation, tegoprubart was administered to the patient as a novel, key component of a chronic immunosuppressive regimen designed to suppress the immune system and prevent the body from rejecting the implanted organ. In prior clinical research, tegoprubart has demonstrated a favorable safety and tolerability profile across multiple indications, including kidney transplantation, as well as clinical benefit in the prevention of rejection and the protection of organs after transplantation.

“The historic procedure we conducted on our courageous patient brings us to a pivotal moment in the history of organ transplantation. It is also a critical step in our ongoing mission to address the growing shortage of available organs,” said Muhammad M. Mohiuddin, MD, professor of surgery at University of Maryland School of Medicine (UMSOM) and scientific/program director of its Cardiac Xenotransplantation Program. “The ability to expand options in all areas including access to available organs and strategies to reduce the risk of rejection means that we are getting closer to realizing the full potential of transplantation for patients. I look forward to continued advancements so that we can hopefully make xenotransplantation an available organ source for patients in the years ahead.”

Eledon is advancing multiple research efforts related to the use of tegoprubart to reduce the risk of rejection in organ transplant. In collaboration with eGenesis, the company is currently advancing preclinical studies in which tegoprubart will be administered as part of an immunosuppression regimen to reduce the risk of rejection in nonhuman primate recipients in xenotransplant procedures. The company recently announced initiation of patient dosing in the phase 2 BESTOW clinical trial to further assess the use of tegoprubart in kidney transplantation and expects to present an updated readout from its ongoing phase 1b kidney transplantation study in November 2023. BESTOW is a head-to-head superiority study evaluating tegoprubart vs. standard of care in kidney transplantation, with a primary endpoint assessment of kidney graft function (eGFR) at 52 weeks.

The Risk of Organ Failure in Transplantation

In transplantation procedures, organ rejection is a major cause of graft failure which can be a life-threatening condition. To reduce the risk of organ damage and rejection, patients are typically treated with immunosuppressive therapies including calcineurin inhibitors (CNIs) such as tacrolimus. Strategies to better and more safely protect transplanted organs and thus increase how long they function represent a significant area of unmet need in organ transplantation.

About Eledon Pharmaceuticals and Tegoprubart (formerly AT-1501)

Eledon Pharmaceuticals is a clinical stage biotechnology company with immunology expertise that is developing therapies to protect and prevent rejection of transplanted organs, as well as to treat amyotrophic lateral sclerosis (ALS). The Company’s lead compound in development is tegoprubart, an anti-CD40L antibody with high affinity for CD40 Ligand (also called “CD154”), a well-validated biological target with broad therapeutic potential. 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 planned clinical trials and the Company’s other future expectations, plans and prospects, 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 sides, 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
[email protected]

Media Contact:

Jenna Urban
Berry & Company Public Relations
(212) 253 8881
[email protected]

Source: Eledon Pharmaceuticals

GeoVax Labs, Inc. (GOVX) – Positive Data From CM04S1 Phase 2 and Preclinical Trials

Posted on by [email protected]


Monday, September 25, 2023

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as 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, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades.

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

GEO-CM04S1Phase 2 Clinical and Preclinical Data Show Efficacy. GeoVax announced publication of initial Phase 2 data from the CM04S1 trial in immunocompromised patients that showed significant immune responses. A poster presentation at a medical meeting showed preclinical data on CM04S1 efficacy against multiple variant strains. We believe both publications support our expectations that CM04S1 can effectively stimulate both humoral and cellular immunity.

Initial Responses Seen In Immunocompromised Patients. GeoVax announced the publication of initial data from its Phase 2 trial for GEO-CM04S1 in immunocompromised patients with hematological malignancies in the journal Vaccines. The data showed both humoral and cellular immune responses in patients with reduced immune function that have difficulty responding to vaccination. The immune markers were superior or comparable to historical cohorts from healthy patients receiving the Pfizer mRNA vaccine.


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Biotech Company Abpro Poised for Growth Through Merger with SPAC

Posted on by [email protected]

Abpro, an emerging biotechnology company developing novel antibody therapies, has entered into a definitive agreement to go public via a merger with Atlantic Coastal Acquisition Corp. II, a special purpose acquisition company (SPAC). The deal values Abpro at $725 million and will provide capital to advance its drug pipeline.

Abpro specializes in leveraging its proprietary technology platform to create next-generation antibody treatments for cancer, eye diseases, and viral infections. The company aims to develop breakthrough immunotherapies to help patients facing life-threatening conditions.

Though Abpro is still in the preclinical phase, it has made significant progress with its pipeline of antibody therapies. Its lead candidates target HER2+ cancers, which include aggressive forms of breast, gastric, and colorectal cancer. Abpro is also pursuing antibodies for COVID-19 treatment and ophthalmic conditions like wet AMD and DME.

Last year, Abpro announced a partnership with South Korea’s Celltrion to further develop ABP 102, an antibody-based treatment for HER2+ cancers. Under the deal, Abpro received a direct equity investment from Celltrion along with eligibility for up to $1.75 billion in milestone payments.

Abpro leverages its DiversImmune platform to design diverse antibody libraries and identify optimal drug candidates. The technology enables more precise targeting compared to conventional antibodies.

Take a look at Noble Capital Markets Senior Biotechnology Research Analyst Robert LeBoyer’s coverage list.

The merger with Atlantic Coastal will provide capital for Abpro to advance its most promising therapies into clinical studies. Abpro also plans to use the funds for business development activities and expanding its pipeline.

Atlantic Coastal is a SPAC focused on finding and merging with high-potential healthcare companies. The transaction is expected to close in Q2 2024, at which point the combined company will trade publicly.

Commenting on the merger, Abpro CEO Ian Chan stated: “This milestone will accelerate getting our therapies to patients needing life-changing treatments.”

Abpro represents an attractive investment opportunity within biotech. Analysts project the global antibody technology market to reach $272 billion by 2030, driven by rising demand for targeted immunotherapies. With its next-generation platform and infusion of growth capital, Abpro is well-positioned to compete in this thriving sector.

The transaction comes amidst a wave of biotech SPAC deals, as pre-revenue companies aim to access public growth financing. With its proprietary technology and strategic partnership in place, Abpro seems poised to leverage this deal to evolve from an R&D startup into a fully integrated biopharma company.

Explore other SPAC Mergers via Spactrac reports from Noble Capital Markets

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Release – Ocugen, Inc. Announces Connie Collingsworth Joins Business Advisory Board

Posted on by [email protected]

Research News and Market Data on OCGN

September 21, 2023

MALVERN, Pa., Sept. 21, 2023 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that Connie Collingsworth, former Chief Operating Officer of the Bill and Melinda Gates Foundation, will join the Company’s Business Advisory Board (BAB). The BAB was established in June 2023 to assist in driving public/private partnerships with governments around the world; pursuing business collaborations, partnerships, and licensing opportunities; creating awareness of the Company’s differentiated capabilities; and promoting access to the Company’s therapies around the world.

“Connie brings value-added expertise in all aspects of strategic growth and organizational governance—across a variety of industries—that will offer unique insights to the BAB,” said Dr. Shankar Musunuri, Chairman, CEO and Co-founder of Ocugen. “Connie’s deep financial background at a global level will provide meaningful counsel to Ocugen as we pursue new business development opportunities to support and evolve our clinical programs.”

Ms. Collingsworth has been a primary advisor to Bill Gates, Melinda French Gates, and Warren Buffett regarding governance. During her tenure with the Bill and Melinda Gates Foundation, she designed and implemented the core operational infrastructure and created the intellectual property strategy known as “Global Access,” as well as advising on the creation of a $2.5 billion strategic investment fund.

“I am inspired by Ocugen’s commitment to not only developing novel therapies that address unmet medical needs for patients with serious conditions, but their passion to ensure access to all patients around the world,” said Ms. Collingsworth. “I look forward to sharing my diverse experiences as an executive and a board member so that patients can potentially benefit.”

Ms. Collingsworth joins Senator Pat Toomey, Ambassador Joseph W. Westphal, Ph.D., and Dennis Carey, Ph.D. on the BAB. These advisors will work alongside the Executive Leadership Team to offer guidance to enable the Company to fulfill its mission and achieve its short- and long-term strategy.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on Twitter and LinkedIn.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
Head of Corporate Communications
[email protected]

Source: Ocugen