Health Archives - Page 26 of 31

Axcella Therapeutics (AXLA) – Regulatory Pathway Clarified for AXA1125

Posted on February 17, 2023February 17, 2023 by cpereira@noblefcm.com

Friday, February 17, 2023

Axcella is a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using compositions of endogenous metabolic modulators (EMMs). The company’s product candidates are comprised of EMMs and derivatives that are engineered in distinct combinations and ratios to restore cellular homeostasis in multiple key biological pathways and improve cellular energetic efficiency. Axcella’s pipeline includes lead therapeutic candidates in Phase 2 development for the treatment of Long COVID and non-alcoholic steatohepatitis (NASH), and the reduction in risk of overt hepatic encephalopathy (OHE) recurrence. The company’s unique model allows for the evaluation of its EMM compositions through non-IND clinical studies or IND clinical trials. For more information, please visit www.axcellatx.com.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

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

Regulatory Pathway Clarified For AXA1125. Axcella announced acceptance of its IND for a Phase 2b/3 trial testing AXA1125 in Long COVID. As a newly recognized condition with no approved drugs, the requirements for clinical trials and regulatory approval were unknown. We view the announcement as significant milestone that establishes the regulatory pathway for AXA1125 in Long COVID. The proposed trial has been accepted for both US and UK regulatory approval, allowing Axcella to move the program forward.

Conference Call Reiterates Details For Long Covid Trial As anticipated, the FDA and MHRA will accept a single, placebo-controlled study for regulatory approval in the US and UK. The study will include endpoints to assess mental and physical functions that are common symptoms of Long COVID. The planned enrollment is about 300 patients, with a treatment period of 3 months.

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*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 – PDS Biotech Announces Preclinical Publication in Peer Reviewed Viruses Journal Showing Superior CD4 T Cell Induction by Infectimune™

Posted on February 16, 2023February 16, 2023 by aweinsoff@channelchek.com

Research News and Market Data on PDSB

Infectimune™ (R-DOTAP) nanoparticles significantly enhance cytokine-inducing, CD4 T cell responses compared to leading commercial adjuvants being used in approved vaccines

FLORHAM PARK, N.J., Feb. 16, 2023 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, announced that new research performed in the laboratory of preeminent CD4 T cell researcher, Andrea Sant, PhD at the University of Rochester Center for Vaccine Biology and Immunology, was published in the peer-reviewed journal, Viruses. The preclinical research studied Infectimune™, PDS Biotech’s novel investigational infectious disease immune activating platform, and demonstrated the technology’s potency in eliciting CD4 T cells. The studies focused on comparing Infectimune™ induced immune responses following primary vaccination against influenza with immune responses induced by leading vaccine adjuvants. This publication follows a recent article in Viruses highlighting the ability of Infectimune™ to generate a broad immune response against viruses, including SARS-CoV-2 and multiple strains of influenza.

The paper, titled, “R-DOTAP cationic lipid nanoparticles outperform squalene-based adjuvant systems in elicitation of CD4 T cells after recombinant influenza hemagglutinin vaccination,” reported findings from a preclinical study investigating the ability of Infectimune™ (R-DOTAP) to promote CD4 T cell responses to vaccination with recombinant influenza protein. Infectimune™ was compared to AddaVax™, which is analogous to commercial adjuvant MF59®, and AddaVax™ combined with CpG, a commercial adjuvant, using HA-B as the influenza vaccine antigen. Results from the study concluded that Infectimune™ dramatically enhanced CD4 T cell responses to recombinant HA-B proteins relative to AddaVax™ and AddaVax™ plus CpG. Further, the Infectimune™ elicited CD4 T cells displayed abundant Interferon (IFN)-gamma and Interleukin (IL)-2 production that are critical for protective immunity. CD4 T cells are documented to present multiple functions including CD8 T cell expansion and antibody responses as well as direct anti-viral effects and potentiation of antigen presenting function to enhance protection against viral infection.

“Influenza remains challenging due to low immune responses, especially in the elderly. Thus, there is a significant opportunity to develop a flu vaccine that induces broadly protective responses to influenza,” stated Dr. Gregory Conn, Chief Scientific Officer of PDS Biotech.

Dr. Sant, the senior author on the paper stated, “These results showing the potency of R-DOTAP to promote epitope-specific, cytokine-inducing CD4 T cells against a recombinant influenza antigen are exceptionally promising.”

The preclinical research published in Viruses demonstrates the ability of Infectimune™ to significantly boost CD4 T cell activity, suggesting that Infectimune™ based vaccines could provide durable protection against seasonal flu and potentially emerging pandemic flu.

The research was supported by grants from the NIAID Collaborative Influenza Vaccine Innovation Centers (CIVICs) program and funded in part by the National Institute of Allergy and Infectious Diseases.

About Infectimune™

Infectimune™ is a novel investigational immune activating platform that generates broad and robust antibody and T cell responses that provide durable protection against infectious disease. Infectimune™ based vaccines are given by intramuscular injection and generate robust and durable protection against infectious agents in preclinical studies. Infectimune™ based vaccines have demonstrated safety in preclinical studies and appear to provide more robust and longer-lasting protection against infectious disease.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune®, PDS0301, and Infectimune™ T cell-activating platforms. We believe our targeted Versamune® and PDS0301 based candidates have the potential to overcome the limitations of current immunotherapy approaches through the activation of the right type, quantity and potency of T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the ability to reduce tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV16-associated cancers in multiple Phase 2 clinical trials. Our Infectimune™ based vaccines have also demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T cell responses, including long-lasting memory T cell responses in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

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 PDS0101, PDS0203 and other Versamune® and Infectimune™ 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 PDS0101, PDS0203 and other Versamune® and Infectimune™ 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 our 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 success of the Company’s license agreements, including the potential for the clinical and nonclinical data available under the Company’s exclusive license agreement with Merck KGaA to aid in the development of the Versamune® platform; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. 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 risk factors included in the Company’s annual and periodic reports filed with the SEC. 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 and Infectimune™ is a trademark of PDS Biotechnology.
AddaVax™ is a trademark of InvivoGen.
MF59® is a registered trademark of Novartis AG.

Investor Contacts:
Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: drandolph@pdsbiotech.com

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: pdsb@cg.capital

Media Contacts:
Tiberend Strategic Advisors, Inc.
Dave Schemelia
Phone: +1 (609) 468-9325
dschemelia@tiberend.com

Bill Borden
Phone: +1 (732) 910-1620
bborden@tiberend.com

Release – Tonix Pharmaceuticals to Participate in Event Titled, “Long COVID: What Will it Take to Accelerate Therapeutic Progress?”

Posted on February 16, 2023February 16, 2023 by aweinsoff@channelchek.com

Research News and Market Data on TNXP

February 16, 2023 7:00am EST

Co-Hosted by the Biotechnology Innovation Organization (BIO) and Solve M.E., an Advocacy Group for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME)

CHATHAM, N.J., Feb. 16, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals, will present at a virtual event co-hosted by BIO and Solve M.E. titled, “Long COVID: What Will it Take to Accelerate Therapeutic Progress?”, which is being held February 21, 2023 from 1:00 – 4:30 p.m. ET. Dr. Lederman will present during the session “Clinical Studies and Emerging Therapeutic Approaches”, which begins at approximately 3:10 p.m. ET.

According to Solve M.E., the session will cover emerging research in Long COVID, as well as the existing body of data in other post-infection diseases like CFS/ME. The session will feature perspectives from a host of participants, including government, academic, and industry researchers, patient groups, funding sources, and policymakers.

Registration is open to the general public and is required in advance through the BIO website found here. The presentation will be available after the event, under the Presentations tab of the Tonix website at www.tonixpharma.com.

About Solve M.E.

Solve M.E. is a non-profit organization that serves as a catalyst for critical research into diagnostics, treatments, and cures for CFS/ME, Long COVID and other post-infection conditions.

About BIO

BIO is the world’s largest advocacy association representing member companies, state biotechnology groups, academic and research institutions, and related organizations across the United States and in 30+ countries.

About Long COVID or Post-Acute Sequelae of SARS-CoV-2 (PASC)

Although most people recover from COVID-19 within weeks of the acute illness, a substantial portion develop a chronic syndrome called Long COVID. These individuals experience a constellation of symptoms long past the time of recovery from acute COVID-19. Most Long COVID patients who have been studied appear to have cleared the SARS-CoV-2 virus from their systems. The symptoms of Long COVID can include fatigue, sleep disorders, pain, fevers, shortness of breath, cognitive impairment described as “brain fog” or memory disturbance, gastrointestinal symptoms, anxiety, and depression. Long COVID can persist for months and can range in severity from mild to incapacitating. Several cohort studies have reported that persistence of symptoms following SARS-CoV-2 infection occurs in more than 30% of patients.¹ While typically associated with moderate or severe COVID-19, Long COVID can occur after mild COVID-19 or even after asymptomatic SARS-CoV-2 infection. Patients with Long COVID are sometimes referred to as “long-haulers”. Long COVID is a chronic disabling condition that is expected to result in a significant global health and economic burden.² In response to the urgent need for therapies that address Long COVID, Congress awarded $1.15 billion to the National Institutes of Health to study Long COVID last December.³ While the vaccines available in the U.S. under Emergency Use Authorization have been shown to prevent acute COVID, their ability to prevent Long COVID is unknown. There is currently no approved drug for the treatment of Long COVID.

Tonix Pharmaceuticals Holding Corp.^*

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022 and interim data expected in the second quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix initiated a Phase 2 study in Long COVID in the third quarter of 2022. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the second quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), a small molecule in development for chronic migraine, is being studied in a potential pivotal Phase 2 study that initiated enrollment in the first quarter of 2023 and for which interim data is expected in the fourth quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily formulation of tianeptine being developed as a potential treatment for major depressive disorder (MDD) with a Phase 2 study expected to be initiated in the first quarter of 2023. Tonix’s rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second quarter of 2023. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox, TNX-801; a next-generation vaccine to prevent COVID-19, TNX-1850; a platform to make fully human monoclonal antibodies to treat COVID-19, TNX-3600; and humanized anti-SARS-CoV-2 monoclonal antibodies, TNX-3800; and a class of broad-spectrum small molecule oral antivirals, TNX-3900. TNX-801, Tonix’s vaccine in development to prevent smallpox and monkeypox, also serves as the live virus vaccine platform or recombinant pox vaccine (RPV) platform for other infectious diseases. A Phase 1 study of TNX-801 is expected to be initiated in the second half of 2023.

^*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

¹Nalbandian, Ani, et al. “Post-acute COVID-19 syndrome.” Nature Medicine (2021): 1-15.

²Briggs, Andrew, and Anna Vassall. “Count the cost of disability caused by COVID-19.” (2021): 502-505.

³The NIH provision of Title III Health and Human Services, Division M–Coronavirus Response and Relief Supplemental Appropriations Act, 2021, of H.R. 133, The Consolidated Appropriations Act of 2021. The bill was enacted into law on 27 December 2020, becoming Public Law 116-260.

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; delays and uncertainties caused by the global COVID-19 pandemic; 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, 2021, as filed with the Securities and Exchange Commission (the “SEC”) on March 14, 2022, 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.

Contacts

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

Olipriya Das, Ph.D. (media)
Russo Partners
Olipriya.Das@russopartnersllc.com
(646) 942-5588

Peter Vozzo (investors)
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Source: Tonix Pharmaceuticals Holding Corp.

Released February 16, 2023

Release – Ocugen To Host Conference Call on Tuesday, February 28 At 8:30 A.M. ET To Discuss Business Updates And Fourth Quarter And Full Year 2022 Financial Results

Posted on February 16, 2023February 16, 2023 by aweinsoff@channelchek.com

Research News and Market Data on OCGN

February 15, 2023

PDF Version

MALVERN, Pa., Feb. 15, 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 and vaccines, today announced that it will host a conference call and live webcast to discuss the Company’s fourth quarter and full year 2022 financial results and provide a business update at 8:30 a.m. ET on Tuesday, February 28, 2023.

Ocugen will issue a pre-market earnings announcement on the same day. Attendees are invited to participate on the call using the following details:

Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers
Conference ID: 8912239
Webcast: Available on the events section of the Ocugen investor site

A replay of the call and archived webcast will be available for approximately 45 days following the event on the Ocugen investor site.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies 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 Communications
IR@ocugen.com

Axcella Therapeutics (AXLA) – Phase 2b/3 Trial Receives Clearance To Move Forward

Posted on February 16, 2023February 16, 2023 by cpereira@noblefcm.com

Thursday, February 16, 2023

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

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

IND Cleared For Phase 2b/3. Axcella Health announced that its IND submission for a Phase 2b/3 trial for AXA1125 in Long COVID Fatigue has been cleared by the FDA. This trial has been designed as a registrational trial to support an NDA filing. In January 2023, Axcella announced the UK’s MHRA (Medicines and Health Regulatory Agency) gave guidance that that a single trial could serve as a registrational trial. Axcella now has clearance in both the US and UK that allows AXA1125 to move forward as planned.

Phase 2b/3 Trial Design. The placebo-controlled trial has a projected enrollment of 300 patients. Patients will be treated for 12 weeks, compared with 4 weeks in the Phase 2a trial. The primary endpoint will be the CFQ11, an accepted clinical tool for measuring fatigue. Secondary endpoints will include the PROMIS questionnaire to measure pain, fatigue, physical function, emotional distress, and ability to return to work.

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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).

ChitogenX Inc. (CHNXF) – Proof of Concept Confirmed in Meniscus Tear Repair Study

Posted on February 15, 2023February 15, 2023 by cpereira@noblefcm.com

Wednesday, February 15, 2023

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

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

Proof of concept confirmed. ChitogenX announced yesterday that in the meniscus tear repair study, the ORTHO-R biopolymer showed residency on the tissue more than 24 hours after surgery. In addition, PRP regenerative cells were recruited and aggregated at the surgery site. PRP alone disperses quickly, but the “sticky” PRP/chitosan biopolymer matrix showed extended tissue adherence.

Meniscus tear repair study in sheep. This pre-clinical study, composed of 22 sheep, tested the subjects’ menisci with sutures alone vs. platelet rich plasma (PRP) alone vs. PRP delivered by ORTHO-R biopolymer. This study represents the Company’s second proof of concept for their ORTHO-R drug/biologic in an orthopedic indication.

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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).

Release – Tonix Pharmaceuticals Announces Exclusive License of Potential Therapeutic or Preventative Fully Human and Murine Anti-SARS-CoV-2 Monoclonal Antibodies

Posted on February 13, 2023February 13, 2023 by aweinsoff@channelchek.com

Research News and Market Data on TNXP

February 13, 2023 7:00am EST

Immunocompromised Individuals, Including Organ Transplant Recipients, Are at Increased Risk of Severe COVID-19 and Poor Clinical Outcomes

SARS-CoV-2 has Mutated to Evade the Formerly EUA-Approved Monoclonal Antibody Therapies and Preventatives

CHATHAM, N.J., Feb. 13, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, today announced that it has exercised an option to obtain an exclusive license from Columbia University for the development of a portfolio of fully human (TNX-3600) and murine (TNX-4100) monoclonal antibodies (mAbs) for the treatment or prophylaxis of SARS-CoV-2 infection. SARS-CoV-2 is the cause of COVID-19. The licensed mAbs were developed as part of a research collaboration and option agreement between Tonix and Columbia University, originally announced in 2020.

“The licensing of these mAbs strengthens our expanding pipeline of next-generation therapeutics to treat and prevent COVID-19,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Immunocompromised individuals, including organ transplant recipients, are at increased risk of severe COVID-19 and poor clinical outcomes¹. We believe there is a need for second-generation mAb treatments and prophylactics^2,3 to protect this population.”

Although five mAb products containing seven distinct mAbs received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for either treatment or prophylaxis of COVID-19, none remain useful or available since January 26, 2023, when the FDA announced that the last remaining mAb, Evusheld®, is no longer authorized⁴. Previously, either the National Institutes of Health COVID Treatment Guidelines Panel or FDA had removed recommendations or approvals for the other mAbs^5,6.

Ilya Trakht, Ph.D., Associate Research Scientist at Columbia University Vagelos College of Physicians and Surgeons said, “We are excited to work with Tonix because of its commitment to developing therapeutics for COVID-19. Our antibody platform has proven robust and capable of rapidly making therapeutically relevant fully human mAbs to SARS-CoV-2. We have also generated murine mAbs, which represent a new approach. Murine mAbs have the potential for neutralizing a broader spectrum of SARS-CoV-2 variants and may be harder for SARS-CoV-2 to evade as we face a multitude of variants.”

To date, the formerly EUA-approved products were derived from the blood of COVID-convalescent patients or humanized mice^7-9. The fully human mAbs generated by Columbia University, TNX-3600, have been isolated using a proprietary system involving a human hybridoma fusion partner.

The Company believes that murine mAbs, such as TNX-4100, have the potential to generate high affinity antibodies that recognize different epitopes on the SARS-CoV-2 spike protein. This is because mice have a different repertoire of antibodies than humans and the technology for generating antibodies optimizes the selection of appropriate B cells by the timing of immunization, harvesting approach and screening platform.

Dr. Lederman added, “The potential therapeutic antibodies licensed from Columbia University leverage our expanding internal development and manufacturing capabilities for biologics. These fully human and murine mAbs and their humanized counterparts build on a base of knowledge from a distinct murine mAb platform in development, TNX-3800, from which we have licensed three humanized mAbs from Curia Global.”

About TNX-3600

TNX-3600 are fully human mAbs generated from SARS-CoV-2+ asymptomatic individuals or COVID-19 convalescent patients, on which Tonix is collaborating with Columbia University. Given the unpredictable trajectory of the SARS-CoV-2 virus and new variants, we seek to contribute to a broad set of mAbs that can be scaled up quickly and potentially combined with other mAbs for the treatment or prophylaxis of SARS-CoV-2 infection.

About TNX-4100

TNX-4100 are murine mAbs and their humanized counterparts generated from mice immunized with SARS-CoV-2 spike protein, on which Tonix is collaborating with Columbia University. Since mice have a different repertoire of antibodies than humans, murine mAbs have the potential for neutralizing a broader spectrum of SARS-CoV-2 variants than fully human mAbs.

Tonix Pharmaceuticals Holding Corp.^*

^*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

¹Haidar G, Mellors JW. Improving the Outcomes of Immunocompromised Patients With Coronavirus Disease 2019. Clin Infect Dis. 2021;73(6):e1397-e1401. Doi:10.1093/cid/ciab397

²Madison Muller, M. November 16, 2022 Bloomberg. “Doctors Are Running Out of Antibody Drugs to Treat Covid as Virus Mutates.” www.bloomberg.com/news/articles/2022-11-16/covid-s-mutations-leave-doctors-with-far-fewer-antibody-drugs-to-treat-virus?

³Callaway, E. Oct 28 2022. Nature (News). COVID ‘variant soup’ is making winter surges hard to predict: Descendants of Omicron are proliferating worldwide — and the same mutations are coming up again and again. www.nature.com/articles/d41586-022-03445-6

⁴https://www.fda.gov/drugs/drug-safety-and-availability/fda-announces-evusheld-not-currently-authorized-emergency-use-us – Accessed Feb 7, 2023

⁵https://www.covid19treatmentguidelines.nih.gov/therapies/anti-sars-cov-2-antibody-products/anti-sars-cov-2-monoclonal-antibodies/ – Accessed Nov 3, 2022

⁶“FDA Updates on Bebtelovimab” – “This information shows that bebtelovimab is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1.” – www.fda.gov/drugs/drug-safety-and-availability/fda-updates-bebtelovimab– Accessed Nov 4, 2022

⁷Hansen J et al. Science. 2020 Aug 21;369(6506):1010-1014. Doi: 10.1126/science.abd0827

⁸Asdaq, S.M.B. et al. A Patent Review on the Therapeutic Application of Monoclonal Antibodies in COVID-19. Int. J. Mol. Sci. 2021, 22, 11953. https://doi.org/10.3390/ijms222111953

⁹Vir isolated sotrovimab from the blood of a SARS-CoV-1 patient

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; delays and uncertainties caused by the global COVID-19 pandemic; 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, 2021, as filed with the Securities and Exchange Commission (the “SEC”) on March 14, 2022, 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.

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

Olipriya Das, Ph.D. (media)
Russo Partners
Olipriya.Das@russopartnersllc.com
(646) 942-5588

Peter Vozzo (investors)
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Source: Tonix Pharmaceuticals Holding Corp.

Released February 13, 2023

Release – Axcella Therapeutics to Participate in the SVB Securities’ 2023 Global Biopharma Conference

Posted on February 10, 2023February 10, 2023 by aweinsoff@channelchek.com

Research News and Market Data on AXLA

February 9, 2023 at 4:45 PM EST

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Feb. 9, 2023– Axcella Therapeutics (Nasdaq: AXLA), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using multi-targeted endogenous metabolic modulator (EMM) compositions, today announced that CEO Bill Hinshaw will present a company update at SVB Securities’ 2023 Global Biopharma Conference, taking place virtually February 14-16, 2023.

Details for Axcella’s participation are as follows:

Date:		Thursday, February 16, 2023
Time:		11:20 am Eastern Time
Webcast:		https://wsw.com/webcast/svb8/axla/1608786

The conference call webcast will be accessible in the Investors & News section on the company’s website at www.axcellatx.com. An archive of the webcast replay will be available on the Company’s website for up to 90 days.

Internet Posting of Information
Axcella uses the “Investors and News” section of its website, www.axcellatx.com, as a means of disclosing material nonpublic information, to communicate with investors and the public, and for complying with its disclosure obligations under Regulation FD. Such disclosures include, but may not be limited to, investor presentations and FAQs, Securities and Exchange Commission filings, press releases, and public conference calls and webcasts. The information that we post on our website could be deemed to be material information. As a result, we encourage investors, the media and others interested to review the information that we post there on a regular basis. The contents of our website shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.

About Axcella Therapeutics (Nasdaq: AXLA)
Axcella is a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using compositions of endogenous metabolic modulators (EMMs). The company’s product candidates are comprised of EMMs and derivatives that are engineered in distinct combinations and ratios to reset multiple biological pathways, improve cellular energetics, and restore homeostasis. Axcella’s pipeline includes lead therapeutic candidates for the treatment of Long COVID, NASH, and the reduction in risk of OHE recurrence. The company’s unique model allows for the evaluation of its EMM compositions through non-IND clinical studies or IND clinical trials. For more information, please visit www.axcellatx.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230209005760/en/

Company
ir@axcellatx.com

Source: Axcella Therapeutics

ChitogenX Inc. (CHNXF) – Offering Announced; Increasing Price Target

Posted on February 10, 2023February 10, 2023 by cpereira@noblefcm.com

Friday, February 10, 2023

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

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

Raising up to $6.1 million gross proceeds. Yesterday, ChitogenX announced a two-part equity placement. The first is a best efforts private placement for up to $4.35 million (currencies in Canadian $) gross proceeds, subject to a $3 million minimum, under a financing prospectus exemption in Part 5A of the Canadian National Instrument 45-106 – Prospectus Exemptions. Second is a non-brokered private placement of up to $1.75 million gross proceeds. The closing of the first offering is conditional upon the closing of the second private placement. The offerings are expected to close on or around February 28, 2023.

Offering terms. Each of the two offerings carry the same terms priced at $0.225 per unit. Each unit consists of one Class A share of common and one purchase warrant exercisable at $0.35 with a 5 year expiration. If the volume weighted daily average trading price exceeds $0.50 for 10 consecutive trading days, ChitogenX can accelerate the expiration date. ChitogenX expects to use the net proceeds to complete enrollment of the Rotator Cuff U.S. Phase I/II clinical trial program, and for working capital and general corporate purposes.

Get the Full Report

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

Release – Tonix Pharmaceuticals Announces Publication of Paper in Viruses Highlighting the Company’s Development of a Vaccine to Protect Against Monkeypox and Smallpox (TNX-801)

Posted on February 9, 2023February 9, 2023 by aweinsoff@channelchek.com

Research News and Market Data on TNXP

February 09, 2023 7:00am EST

Preclinical data demonstrate the efficacy of TNX‐801 vaccination against monkeypox virus challenge in an animal model

Phase 1 trial with TNX-801 for the prevention of monkeypox and smallpox is expected to start in the second half of 2023

CHATHAM, N.J, Feb. 09, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced the publication of a paper entitled, “Single Dose of Recombinant Chimeric Horsepox Virus (TNX‐801) Vaccination Protects Macaques from Lethal Monkeypox Challenge,” in the journal Viruses. The publication demonstrates that a single dose vaccination with TNX‐801 was effective at protecting non-human primates from infection with monkeypox virus. The article can be accessed online at https://www.mdpi.com/1999-4915/15/2/356.

“The global monkeypox outbreak that started in the spring of 2022 reinforced the importance of protecting the population using live virus vaccines,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Consequently, there is a need for an effective and safer, single dose, live replicating vaccine against monkeypox virus. Given the encouraging preclinical data to date, one potential approach is to use a live virus vaccine based on horsepox, such as TNX-801.”

David Evans, Ph.D., FCAHS, Professor and former Vice-Dean (Research) Faculty of Medicine and Dentistry at the University of Alberta and an investigator in the study and author of the publication, said, “It is often forgotten that vaccines don’t always produce sterilizing immunity and so it’s very exciting to be able to report that a horsepox-based vaccine works so well in such a challenging infection model.”

The publication describes data from animals in which eight out of eight vaccinated with TNX-801 were fully protected with sterilizing immunity from a challenge with intra-tracheal monkeypox (central African, or Congo Basin, clade). The vaccinations with TNX-801 were well tolerated as indicated by the lack of any overt clinical disease. These data show that the immunity generated by TNX‐801 was able to provide protection against a lethal challenge with monkeypox virus and is the first study to demonstrate the efficacy of TNX‐801 vaccination against monkeypox virus challenge in a non‐human primate model. Synthetic horsepox virus is the basis for the Company’s TNX-801 vaccine in development to protect against monkeypox and smallpox and for the Company’s Recombinant Pox Virus (RPV) platform to protect against other pathogens, including SARS-CoV-2.

About TNX-801 and TNX-1850

TNX-801 is a live virus vaccine based on horsepox^2,3. Tonix is developing TNX-801 for percutaneous administration as a vaccine to protect against monkeypox and smallpox. Tonix is also developing TNX-1850 (horsepox-based live virus vaccine) for the prevention of COVID-19. TNX-1850 is designed to express the spike protein from the BA.2 variant of SARS-CoV-2. Tonix has previously reported positive data from a SARS-CoV-2 challenge study in non-human primates in which animals were vaccinated with TNX-1800, a horsepox-based vaccine expressing spike protein from the Wuhan strain⁴. Tonix’s TNX-801 is based on the sequence of the 1976 natural isolate Mongolian horsepox clone MNR-763.² Molecular analysis of DNA sequences suggests that TNX-801 is closer than modern smallpox vaccines to the vaccine discovered and disseminated by Dr. Edward Jenner in 1798^5-7. For example, recent studies^8,9 have shown approximately 99.7% colinear identity between TNX-801 and the circa 1860 U.S. smallpox vaccine VK05.¹⁰ The small plaque size in culture of TNX-801 appears identical to the U.S. Centers for Disease Control publication of the natural isolate¹¹. Relative to vaccinia, horsepox has substantially decreased virulence in mice². Dr. Edward Jenner invented vaccination in 1798 and the procedure was called “vaccination” because ‘cow’ is ‘vacca’ in Latin and the inoculum material was initially obtained from lesions on the udders of cows affected by a mild disease known as cowpox. However, Dr. Jenner suspected that cowpox originated from horses⁷. Subsequently, Dr. Jenner and others immunized against smallpox using material directly obtained from horses. The use of vaccines from horses was sometimes called ‘equination’ from the Latin ‘equus’ which means ‘horse’¹². Equination and vaccination were practiced side-by-side in Europe^12,13.

About the Recombinant Pox Virus (RPV) Platform

Horsepox virus and vaccines based on its use as a vector are live replicating viruses that elicit strong immune responses. Live replicating orthopoxviruses, like vaccinia or horsepox, can be engineered to express foreign genes and have been exploited as platforms for vaccine development because they possess; (1) large packaging capacity for exogenous DNA inserts, (2) precise virus-specific control of exogenous gene insert expression, (3) lack of persistence or genomic integration in the host, (4) strong immunogenicity as a vaccine, (5) ability to rapidly generate vector/insert constructs, (6) manufacturable at scale, and (7) ability to provide direct antigen presentation. Horsepox-based vaccines are designed to be single dose, vial-sparing vaccines, that can be manufactured using conventional cell culture systems, with the potential for mass scale production and packaging in multi-dose vials. Tonix’s TNX-801 and RPV vaccine candidates are administered percutaneously using a two-pronged, or “bifurcated” needle. The major cutaneous reaction or “take” to vaccinia vaccine was described by Dr. Edward Jenner in 1796 and has been used since then as a biomarker for protective immunity to smallpox, including in the World Health Organization’s (WHO) accelerated smallpox eradication program that successfully eradicated smallpox in the 1960’s. The “take” is a measure of functional T cell immunity validated by the eradication of smallpox, a respiratory-transmitted disease caused by variola.

About Monkeypox and Smallpox

Monkeypox¹⁴ and smallpox¹⁵ are diseases in humans caused by the monkeypox and smallpox (or variola) viruses, respectively. Monkeypox and variola are closely related orthopox viruses. Vaccination against smallpox with live virus vaccines based on horsepox or vaccinia protects against monkeypox. After routine smallpox vaccination was stopped in about 1970, monkeypox has become a growing problem in Africa. Since May of 2022, approximately 30,000 cases have been identified in the United States.^16,17 There are two distinct clades of the monkeypox virus: the central African (Congo Basin) clade, and the west African clade which is associated with the recent outbreak. Historically, the Congo Basin clade has caused more severe disease than the west African clade. In recent times, the case fatality ratio for the virus is about 3–6%.¹⁸ In November, 2022, the WHO began using a new preferred term “mpox” as a synonym for monkeypox.¹⁹ Smallpox is considered eradicated, but there are concerns about malicious reintroduction.

Tonix Pharmaceuticals Holding Corp.¹

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022 and interim data expected in the second quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix initiated a Phase 2 study in Long COVID in the third quarter of 2022. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the second quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), a small molecule in development for chronic migraine, is being studied in a potential pivotal Phase 2 study that initiated enrollment in the first quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily formulation of tianeptine being developed as a potential treatment for major depressive disorder (MDD) with a Phase 2 study expected to be initiated in the first quarter of 2023. Tonix’s rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second quarter of 2023. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox, TNX-801, a next-generation vaccine to prevent COVID-19, TNX-1850, a platform to make fully human monoclonal antibodies to treat COVID-19, TNX-3600, and humanized anti-SARS-CoV-2 monoclonal antibodies, TNX-3800, recently licensed from Curia. TNX-801, Tonix’s vaccine in development to prevent smallpox and monkeypox, also serves as the live virus vaccine platform or recombinant pox vaccine (RPV) platform for other infectious diseases. A Phase 1 study of TNX-801 is expected to be initiated in the second half of 2023.

¹All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.
²Noyce RS, et al. (2018) PLoS One. 13(1):e0188453
³Tulman ER, et al. (2006) J Virol. 80(18):9244-58.PMID:16940536
⁴Tonix Press Release March 16, 202a https://ir.tonixpharma.com/news-events/press-releases/detail/1255/tonix-pharmaceuticals-reports-positive-covid-19-vaccine
⁵Schrick L et al. (2017) N Engl J Med. 377:1491.
⁶Qin et al. (2015) J. Virol. 89:1809.
⁷Jenner E. “An Inquiry Into the Causes and Effects of the Variolae Vaccinae: A Disease Discovered in Some of the Western Counties of England, Particularly Gloucestershire, and Known by the Name of the Cow Pox.” London: Sampson Low, 1798.
⁸Brinkmann A et al, Genome Biology (2020) 21:286 https://doi.org/10.1186/s13059-020-02202-0
⁹Duggan A et al. Genome Biology (2020) 21:175 https://doi.org/10.1186/s13059-020-02079-z
¹⁰Tonix press release. Dec 4, 2020 https://ir.tonixpharma.com/news-events/press-releases/detail/1236/vaccine-genome-researchers-report-99-7-colinear-identity
¹¹Trindale GS et al. (2016) Viruses (12). Pii: E328. PMID:27973399
¹²Esparza E, et al (2017) Vaccine. 35(52):7222-7230.
¹³Esparza J et al. (2020) Vaccine.; 38(30):4773-4779.
¹⁴www.cdc.gov/poxvirus/monkeypox/about.html
¹⁵www.cdc.gov/smallpox/research/
¹⁶Mandavilli, A. The New York Times. May 26, 2020. “Who is protected against monkeypox”
¹⁷ www.cdc.gov/poxvirus/monkeypox/response/2022/us-map.html – Accessed Feb 8, 2023
¹⁸ https://www.who.int/news-room/fact-sheets/detail/monkeypox#:~:text=There%20are%20two%20distinct%20genetic,thought%20to%20be%20more%20transmissible – Accessed Feb 8, 2023
¹⁹ https://www.who.int/news/item/28-11-2022-who-recommends-new-name-for-monkeypox-disease – Accessed Feb 8, 2023

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

Forward Looking Statements

Contacts

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

Olipriya Das, Ph.D. (media)
Russo Partners
Olipriya.Das@russopartnersllc.com
(646) 942-5588

Peter Vozzo (investors)
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Source: Tonix Pharmaceuticals Holding Corp.

Released February 9, 2023

Release – PDS Biotech Announces Publication of Preclinical Infectimune™ Based Vaccine Studies Demonstrating Effective Protection Against Viral Infection in Peer-Reviewed Journal, Viruses

Posted on February 8, 2023February 8, 2023 by aweinsoff@channelchek.com

Research News and Market Data on PDSB

Infectimune™ induced neutralizing antibody and robust T cell responses completely protecting animals against sickness after lethal challenge with live SARS-CoV-2 or influenza viruses

FLORHAM PARK, N.J., Feb. 08, 2023 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, announced that preclinical studies involving Infectimune™, PDS Biotech’s novel investigational immune activating platform, were published in the peer-reviewed journal, Viruses, demonstrating the technology’s ability to generate a broad immune response against viruses, including SARS-CoV-2 and multiple strains of influenza.

The paper, titled, “Recombinant Protein Vaccines Formulated with Enantio-Specific Cationic Lipid R-DOTAP Induce Protective Cellular and Antibody-Mediated Immune Responses in Mice,” highlighted results from preclinical studies. It was found that Infectimune™ (R-DOTAP) promoted strong T cell and antibody immune responses in both single- and multi-viral antigen (protein) containing vaccines. The vaccines induced antigen-specific and multi-cytokine-inducing CD8 and CD4 T cells associated with antigen-specific killing and immune memory, respectively.

Infectimune™ was tested in separate animal models of SARS-CoV-2 and influenza. Data suggest that Infectimune™ promotes robust neutralizing antibody and T cell responses to all three recombinant SARS‐CoV-2 spike protein variants tested in the studies. The investigational universal flu vaccine, containing two computationally optimized broadly reactive antigen (COBRA) influenza proteins, demonstrated induction of T cell and neutralizing antibodies against multiple strains of influenza. Robust T cell responses were also generated to influenza nucleoprotein, a protein contained in non-mutating regions of the virus. Importantly, these Infectimune™ induced neutralizing antibody and T cell responses completely protected animals from lethal challenges with live SARS-CoV-2 and influenza viruses. The Infectimune™ based vaccines also facilitated significant dose sparing of the viral protein antigens.

“We are encouraged by the data reported in Viruses which suggest that Infectimune™ is a promising platform for the effective delivery of recombinant protein antigens to the immune system and activation of the immune system for the development of next‐generation universal vaccines against respiratory viruses, including influenza and SARS-CoV-2,” stated Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech and one of the co-authors of the study. “PDS Biotech is advancing our Infectimune™ based programs, and these studies highlight the potential of Infectimune™ to induce memory T cell responses against viral antigens that can provide the immune system with long-term memory and sustained protection against infectious pathogens over an extended period of time.”

The research was funded in part by the National Institute of Allergy and Infectious Diseases, the University of Kentucky Flow Cytometry & Immune Monitoring and PDS Biotech.

About Infectimune™

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune^®, PDS0301, and Infectimune™ T cell-activating platforms. We believe our targeted Versamune^® and PDS0301 based candidates have the potential to overcome the limitations of current immunotherapy approaches through the activation of the right type, quantity and potency of T cells. To date, our lead Versamune^® clinical candidate, PDS0101, has demonstrated the ability to reduce tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV16-associated cancers in multiple Phase 2 clinical trials. Our Infectimune™ based vaccines have also demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T cell responses, including long-lasting memory T cell responses in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

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 PDS0101, PDS0203 and other Versamune^® and Infectimune™ 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 PDS0101, PDS0203 and other Versamune^® and Infectimune™ 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 our 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; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. 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 risk factors included in the Company’s annual and periodic reports filed with the SEC. 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 and Infectimune™ is a trademark of PDS Biotechnology.

Investor Contacts:
Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: drandolph@pdsbiotech.com

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: pdsb@cg.capital

Media Contacts:
Tiberend Strategic Advisors, Inc.
Dave Schemelia
Phone: +1 (609) 468-9325
dschemelia@tiberend.com

Bill Borden
Phone: +1 (732) 910-1620
bborden@tiberend.com

Release – Onconova Therapeutics Announces Additional Clinical Data Demonstrating Rigosertib’s Monotherapy Activity In Rdeb-Associated Squamous Cell Carcinoma

Posted on February 7, 2023February 7, 2023 by aweinsoff@channelchek.com

Research News and Market Data on ONTX

Two of two evaluable participants in an ongoing investigator-sponsored program of rigosertib in RDEB-associated squamous cell carcinoma (SCC) have achieved a complete response of all cancerous skin lesions

First evaluable participant has been in complete remission with no signs of metastatic disease for >18 months; the second patient has achieved a complete response in all squamous cell skin lesions following four cycles of treatment and remains on therapy with additional scans to follow to evaluate metastatic disease

Onconova plans to review initial data with regulators to gain insights on the optimal regulatory pathway for rigosertib in RDEB-associated SCC, an ultra-rare and invariably fatal condition

NEWTOWN, Pa., Feb. 07, 2023 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that the second of two evaluable participants in an investigator-initiated Phase 2 program evaluating rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC) achieved a complete response of all cancerous skin lesions following 4 treatment cycles and remains on oral rigosertib.

The Company previously announced that the RDEB-associated SCC program’s first evaluable participant achieved a RECIST-defined complete response. Both of the program’s evaluable participants remain on therapy, with the first participant in complete remission with no signs of metastatic disease for more than 18 months. Rigosertib continues to demonstrate a favorable safety profile in this indication that is similar to that displayed in prior studies in other indications.

“Though from only two participants, the emerging data from this Phase 2 program show rigosertib displaying a level of anti-cancer activity in RDEB-associated SCC that far exceeds what we have seen with currently available treatments,” said Professor Andrew P South from Sidney Kimmel Cancer Center, Thomas Jefferson University. “Given its ultra-orphan nature and the extremely high unmet need in RDEB-associated SCC, I believe regulatory discussions to enable rigosertib’s expeditious advancement to potential approval in this indication are warranted. In parallel, we plan to continue advancing this Phase 2 program and to report more detailed data at a future medical meeting.”

RDEB is caused by insufficient expression of type VII collagen protein, which is responsible for anchoring the skin’s inner layer to its outer layer. This leads to extreme skin fragility as well as chronic blistering and wound formation with recurrent infections in RDEB patients, many of whom go on to develop metastatic squamous cell carcinoma driven by over expression of polo like kinase 1 (PLK1). RDEB-associated SCC tumors show a highly aggressive and early metastasizing course that makes them the primary cause of death for these patients, with a cumulative risk of death of 70% and 78.7% by ages 45 and 55, respectively^1,2. RDEB-associated SCC can appear in pediatric patients or in young adults. Currently available treatments such as targeted therapies and conventional chemo- and/or radiotherapy have demonstrated limited response rates and poor durability in RDEB-associated SCC^1,3.

Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova, commented, “We are pleased to be building on this Phase 2 program’s initial single-patient data with a second participant showing complete resolution of all cancerous skin lesions, with the most recent patient notably seeing this result after only four cycles of therapy. We look forward to reviewing our findings with the FDA to determine the most expeditious regulatory path for rigosertib in RDEB-associated SCC. In addition, these findings may have important implications beyond this orphan indication, as they and prior preclinical data demonstrate rigosertib’s activity against the PLK1 protein. Although the company is focusing its resources mainly on the lead narazaciclib program, preclinical studies exploring rigosertib’s activity in other PLK1-dependent tumors are underway and will hopefully open a broader regulatory path for rigosertib.”

Onconova and a program investigator plan to present more detailed data on the first two evaluable participants from the Phase 2 RDEB-associated SCC program at a future medical meeting. In addition, preclinical data on rigosertib’s mechanism of action have been accepted for presentation at the American Association for Cancer Research (AACR) Targeting RAS Conference, which is taking place in Philadelphia, Pennsylvania from March 5 – 8, 2023.

About Rigosertib

Rigosertib is an investigational product candidate with a multi-faceted mechanism of action targeting proteins containing the RAS binding domain, allowing it to modulate the PI3K and PLK-1 pathways, as well as the tumor immune microenvironment. It is currently being evaluated in multiple investigator-sponsored studies, including a dose-escalation and expansion Phase 1/2a study of oral rigosertib in combination with nivolumab for patients with KRAS+ non-small cell lung cancer refractory to pembrolizumab, the current standard of care for these patients, and a Phase 2 program evaluating rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa.

About Onconova Therapeutics, Inc.

Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.

Onconova’s novel, proprietary multi-kinase inhibitor narazaciclib (formerly ON 123300) is being evaluated in two separate and complementary Phase 1 dose escalation and expansion studies. These trials are currently underway in the United States and China. Based on preclinical and clinical studies of CDK 4/6 inhibitors, Onconova is also planning a combination trial of narazaciclib with estrogen blockade in advanced endometrial cancer, as well as its clinical study in additional indications.

Onconova’s product candidate rigosertib is being studied in multiple investigator-sponsored studies, including a dose-escalation and expansion Phase 1/2a study of oral rigosertib in combination with nivolumab in patients with KRAS+ non-small cell lung cancer, and a Phase 2 program evaluating rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa.

For more information, please visit www.onconova.com.

References

Mellerio et al. Br J Dermatol. 2016 Jan; 174(1):56-67. doi: 10.1111/bjd.14104.
Fine et al. J Am Acad Dermatol. 2009 Feb; 60(2):203-11. doi: 10.1016/j.jaad.2008.09.035.
Stratigos et al. Eur J Cancer. 2020 Mar;128:83-102. doi: 10.1016/j.ejca.2020.01.008.

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to Onconova’s expectations regarding its clinical development and trials, its product candidates, its business and financial position. Onconova has attempted to identify forward-looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “preliminary,” “encouraging,” “approximately” or other words that convey uncertainty of future events or outcomes. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Onconova’s clinical trials, investigator-initiated trials and regulatory agency and institutional review board approvals of protocols, Onconova’s collaborations, market conditions and those discussed under the heading “Risk Factors” in Onconova’s most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q. Any forward-looking statements contained in this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Company Contact:
Mark Guerin
Onconova Therapeutics, Inc.
267-759-3680
ir@onconova.us
https://www.onconova.com/contact/

Investor Contact:
Bruce Mackle
LifeSci Advisors, LLC
646-889-1200
bmackle@lifesciadvisors.com

MustGrow Biologics Corp. (MGROF) – Commercialization Is The Goal

Posted on February 7, 2023February 7, 2023 by cpereira@noblefcm.com

Tuesday, February 07, 2023

Joe Gomes, Managing Director – Generalist Analyst, Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

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

Conversation With CEO Giasson. We had an opportunity to speak with MustGrow Biologics CEO Corey Giasson about milestones and goals for 2023. In a nutshell, 2023 will be about moving towards commercialization of MustGrow’s organic mustard-derived crop protection and food preservation technology. We believe MustGrow continues to have ample capital to support the Company through commercialization.

Timing? While one cannot pinpoint an exact date, we believe commercialization of TerraMG could occur in 2023, resulting in revenue generation in 2024. The first commercial application likely will be for preplant soil biofumigation, an estimated $1.3 billion market in fruit and vegetables. Additional field trials are currently being conducted for bananas, canola, and pulse crops in this area.

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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).