Category: Health

Release – Strengthening America’s Biosecurity: GeoVax Advances Domestic Vaccine Capability

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

 

  • Last updated: 29 January 2025
  • Created: 29 January 2025
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Addressing Critical U.S. Vulnerabilities in Vaccine Supply and National Preparedness

ATLANTA, GA, January 29, 2025 — GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies, today highlighted that it is committed to playing a pivotal role in reinforcing America’s biosecurity through its GEO-MVA vaccine, designed to combat both smallpox and Mpox.  In light of recent global health challenges, the United States has recognized the critical need to reduce dependence on foreign vaccine suppliers and bolster domestic production capabilities.

The 2022 Mpox pandemic significantly depleted the U.S. Strategic National Stockpile (SNS) of vaccines, exposing vulnerabilities in the nation’s preparedness for emerging health threats. Compounding this issue is the nation’s reliance on a single foreign manufacturer for smallpox and Mpox vaccines. This dependency poses a strategic risk, especially considering the current Clade I Mpox outbreak in Africa, characterized by an estimated 5%-10% mortality rate, increasingly migrating to other regions worldwide.

GeoVax’s GEO-MVA vaccine is expected to offer a timely and strategic solution. Developed on the proven Modified Vaccinia Ankara (MVA) platform, a clinical batch of GEO-MVA has recently been produced under current Good Manufacturing Practice (cGMP) production.  Clinical evaluation of the vaccine is expected to begin this year.  The Company’s innovative advanced MVA manufacturing process is anticipated to provide scalable, flexible and cost-effective vaccine production, reducing reliance on foreign vaccine manufacturers and reinforcing domestic biosecurity.

America First – Bolstering U.S. Biomanufacturing Resilience

The importance of onshoring medical product manufacturing has garnered bipartisan support among U.S. legislators. Reps. Earl L. “Buddy” Carter (R-GA), Elissa Slotkin (D-MI), Chrissy Houlahan (D-PA), and Gus Bilirakis (R-FL) officially launched the bipartisan Domestic Pharmaceutical Manufacturing Caucus for the 118th Congress. (https://buddycarter.house.gov/news/documentsingle.aspx?DocumentID=11059)

Representatives Blake Moore (R-UT), August Pfluger (R-TX), Mark Green (R-TN), and former Representative Brad Wenstrup (R-OH) have also sought feedback on policy solutions to secure and enhance domestic medical supply chains. (https://blakemoore.house.gov/media/press-releases/moore-wenstrup-pfluger-and-green-release-request-for-information-on-policy-solutions-to-secure-and-enhance-domestic-medical-supply-chains)

In addition, John Crowley, President of the Biotechnology Innovation Organization (BIO), has underscored the urgency of reshoring biomanufacturing capacity to protect public health and national security. (https://bio.news/biosecurity/national-security-biosecurity-biomanufacturing-biotech-manufacturing-john-crowley-bio/)

GeoVax’s commitment to domestic vaccine production aligns seamlessly with these national initiatives, positioning GEO-MVA as a cornerstone in America’s strategy to achieve vaccine independence and enhance public health preparedness.

David Dodd, GeoVax’s Chairman and CEO, stated, “With GEO-MVA, we intend to create the first U.S.-based source for a Mpox vaccine, an important biodefense goal.”

Recent Conference Presentations

GeoVax CEO David Dodd recently presented the Company’s strategic initiatives and the potential of GEO-MVA at:

  • Biotech Showcase: January 14, 2025
  • Emerging Growth Conference: January 16, 2025

For additional details, visit www.geovax.com.

About GEO-MVA

GEO-MVA is a Mpox and smallpox vaccine candidate utilizing U.S. NIH rights acquired by GeoVax. Designed for robust immune responses, GEO-MVA is anticipated to offer a safe and effective solution for both immunocompromised and general populations​.

About GeoVax

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

Forward-Looking Statements

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

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

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

Release – Unicycive Therapeutics Announces the Publication of Patient Perspectives on Phosphate Management in the Journal of Nephrological Science

Posted on by aweinsoff@channelchek.com

Research News and Market Data on UNCY

January 28, 2025 7:00am EST 

Large pill size, high pill burden and palatability were identified as key barriers for phosphate binder adherence

LOS ALTOS, Calif., Jan. 28, 2025 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”), today announced the publication of a review on patient perspectives regarding phosphate management in the peer-reviewed journal, Journal of Nephrological Science.

The publication, entitled “Patient Perspectives: The Effects of Contemporary Phosphorus Management on Quality of Life,” examines the challenges of phosphate management therapies from patients’ viewpoints, focusing on the limitations of current phosphate binders and their effect on patients’ quality of life. The publication underscores key findings from patient surveys and medical literature, identifying critical barriers to effective phosphorus management and emphasizing the need for patient-centered approaches to improve clinical outcomes and patient satisfaction.

“In therapeutic categories with significant patient non-adherence to standard of care like chronic kidney disease (CKD), it is essential to understand the factors disrupting medical intervention in order to offer physicians and patients innovative solutions,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “We believe products like Oxylanthanum Carbonate (OLC), which is characterized by small pill size, lower pill burden, and easy-to-swallow tablets, have the potential to address many of the inherent challenges in phosphorus management that often lead to nonadherence and poor serum phosphate control. If approved, we look forward to offering OLC to CKD patients on dialysis with hyperphosphatemia.”

Key Findings:

  • Hyperphosphatemia is linked to increased mortality risk.
  • Dialysis patients often face a high daily pill burden, with phosphate binders making up about 50% of the total.
  • Nonadherence to phosphate binders is a significant challenge contributing to elevated phosphate levels. Studies show non-adherence rates range from 22% to 74%, with a mean non-adherence rate of 51%.
  • Factors contributing to non-adherence include large pill size, high pill burden, and unpleasant gastrointestinal side effects. Social factors and timing complexities also impact adherence.
  • Engaging patients in discussions about different phosphate binders and their unique characteristics is key to improving adherence and satisfaction. New therapies that reduce pill size or burden while maintaining efficacy could enhance clinical outcomes, quality of life, and the patient-clinician relationship.

The full publication can be accessed here.

About Oxylanthanum Carbonate (OLC)

Oxylanthanum carbonate is a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology being developed for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD). OLC has over forty issued and granted patents globally. Its potential best-in-class profile may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden for patients in terms of number and size of pills per dose that are swallowed instead of chewed. Based on a survey conducted in 2022, Nephrologists stated that the greatest unmet need in the treatment of hyperphosphatemia with phosphate binders is a lower pill burden and better patient compliance.1 The global market opportunity for treating hyperphosphatemia is projected to be in excess of $2.28 billion, with the North America accounting for more than $1 billion of that total.2 Despite the availability of several FDA-cleared medications, 75 percent of U.S. dialysis patients fail to achieve the target phosphorus levels recommended by published medical guidelines.3

Unicycive is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway. The NDA submission package is based on data from three clinical studies (a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study of OLC in CKD patients on dialysis), multiple preclinical studies, and the chemistry, manufacturing and controls (CMC) data. OLC is protected by a strong global patent portfolio including issued patents on composition of matter with exclusivity until 2031, and with the potential for patent term extension until 2035.

About Hyperphosphatemia

Hyperphosphatemia is a serious medical condition that occurs in nearly all patients with End Stage Renal Disease (ESRD). If left untreated, hyperphosphatemia leads to secondary hyperparathyroidism (SHPT), which then results in renal osteodystrophy (a condition similar to osteoporosis and associated with significant bone disease, fractures and bone pain); cardiovascular disease with associated hardening of arteries and atherosclerosis (due to deposition of excess calcium-phosphorus complexes in soft tissue). Importantly, hyperphosphatemia is independently associated with increased mortality for patients with chronic kidney disease on dialysis. Based on available clinical data to date, over 80% of patients show signs of cardiovascular calcification by the time they become dependent on dialysis.4

Dialysis patients are already at an increased risk for cardiovascular disease (because of underlying diseases such as diabetes and hypertension), and hyperphosphatemia further exacerbates this. Treatment of hyperphosphatemia is aimed at lowering serum phosphate levels via two means: (1) restricting dietary phosphorus intake; and (2) using, on a daily basis, and with each meal, oral phosphate binding drugs that facilitate fecal elimination of dietary phosphate rather than its absorption from the gastrointestinal tract into the bloodstream.

About Unicycive Therapeutics

Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead drug candidate, oxylanthanum carbonate (OLC), is a novel investigational phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. Positive pivotal trial results were reported in June 2024 for OLC, and a New Drug Application (NDA) is under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) Target Action Date of June 28, 2025. OLC is protected by a strong global patent portfolio including an issued patent on composition of matter with exclusivity until 2031, and with the potential patent term extension until 2035 after OLC approval. Unicycive’s second asset, UNI-494, is a patent-protected new chemical entity in clinical development for the treatment of conditions related to acute kidney injury. UNI-494 has successfully completed a Phase 1 trial. For more information, please visit Unicycive.com and follow us on LinkedIn, X, and YouTube.

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 using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. There are several 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, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2023, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

1Reason Research, LLC 2022 survey. Results here.
2 Fortune Business Insights™, Hyperphosphatemia Treatment Market, 2023-2030
3 US-DOPPS Practice Monitor, May 2021; http://www.dopps.org/DPM
4 Block GA, Klassen PS, Lazarus JM, Ofsthun N, Lowrie EG, Chertow GM. Mineral metabolism, mortality, and morbidity in maintenance hemodialysis. J Am Soc Nephrol. 2004 Aug;15(8):2208-18. doi: 10.1097/01.ASN.0000133041.27682.A2. PMID: 15284307.

Investor Contacts:

Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com

Chris Calabrese
LifeSci Advisors
ccalabrese@lifesciadvisors.com

SOURCE: Unicycive Therapeutics, Inc.

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Released January 28, 2025

Release – GeoVax Advanced MVA Manufacturing Process: Aimed to Enhance Vaccine Supply Worldwide

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

 

  • Last updated: 27 January 2025
  • Created: 27 January 2025
  • Hits: 60

Process Expected to Increase Production Yield, Flexibility at Lower Cost

Atlanta, GA – January 27, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company specializing in vaccines and immunotherapies, has shared updates about its development-stage advanced Modified Vaccinia Ankara (MVA) vaccine manufacturing process. This anticipated process provides the potential to not only address today’s pressing health challenges but also paves the way for more efficient, flexible and lower-cost MVA-vaccine manufacturing.

The Power and Versatility of the MVA Platform

The MVA platform is uniquely designed to incorporate multiple antigens into a single vaccine. This versatility allows GeoVax to develop vaccines targeting multiple aspects of a single pathogen or several pathogens simultaneously. Originally developed as a safer smallpox vaccine, the MVA platform offers distinct advantages, including:

  • Protection against diseases such as Mpox and smallpox.
  • Multi-antigen vaccines like GEO-CM04S1, which targets both the Spike (S) and Nucleocapsid (N) antigens of SARS-CoV-2.
  • Stability under minimal refrigeration and the potential for freeze-drying (lyophilization), simplifying distribution in resource-limited settings.

Advancing MVA Manufacturing

Current vaccine manufacturing methods rely on Chicken Embryo Fibroblast (CEF) cells, requiring pathogen-free eggs. This process is costly, time-consuming, and dependent on limited egg supplies, providing barriers to rapid, real-time MVA manufacturing, as well as hindering the flexibility necessary to establish local MVA manufacturing of critically important vaccines.  GeoVax is addressing these barriers through an advanced MVA Manufacturing process utilizing an avian cell line licensed from ProBioGen AG (Berlin). Key features include:

  • A continuous avian suspension cell line process that eliminates the need for pathogen-free eggs.
  • Compatibility with standard manufacturing equipment, reducing setup time, simplifying the MVA manufacturing process, increasing scalability and lowering manufacturing costs.

This advanced MVA manufacturing process is expected to significantly simplify vaccine production, particularly in middle- and low-income regions where supply chain issues often hinder access to critical vaccines.

Addressing Global Health Needs

“Our advanced MVA manufacturing process represents not only a transformative manufacturing advance but also addresses a public health imperative,” said David Dodd, Chairman and CEO of GeoVax. “By tackling disease protection, logistical hurdles, and manufacturing challenges, we aim to empower regions like Africa with the tools needed to combat current and future health crises.”

GeoVax’s MVA vaccines have demonstrated robust performance in clinical trials, with ongoing Phase 2 studies for GEO-CM04S1, its COVID-19 vaccine candidate, showing broad and durable immune responses. Supported by its BARDA Project NextGen Award and partnerships with leading manufacturing and development organizations, GeoVax is positioned to enhance vaccine access and delivery on a global scale.

Recent Conference Presentations

GeoVax CEO David Dodd recently presented the company’s strategic initiatives and the potential of GEO-MVA at:

  • Biotech Showcase: January 14, 2025
  • Emerging Growth Conference: January 16, 2025

About GeoVax

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

Forward-Looking Statements

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

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

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

Release – Ocugen, Inc. Announces Investigational New Drug Application in Effect After Review by FDA to Initiate Phase 1 Clinical Trial Evaluating First-in-Class OCU500 Inhaled Vaccine Candidate for COVID-19

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

January 27, 2025

PDF Version

  • OCU500 will be administered via inhalation and as a nasal spray
  • COVID-19 remains a substantial public health threat in the U.S. and around the world
  • Phase 1 clinical trial is anticipated to start in 2Q 2025

MALVERN, Pa., Jan. 27, 2025 (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 the U.S. Food and Drug Administration (FDA) has reviewed the Company’s Investigational New Drug (IND) application and it is in effect. This is a critical step toward the initiation of the Phase 1 clinical trial for OCU500—an inhaled mucosal vaccine for COVID-19. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, will sponsor and conduct the Phase 1 trial to assess the safety, tolerability, and immunogenicity of OCU500 administered via two different routes, inhalation into the lungs and intranasally as a spray.

“We are grateful for our ongoing collaboration with NIAID and pleased to bring our novel vaccine technology into the clinic through Project NextGen,” said Mike Shine, Senior Vice President, Commercial at Ocugen. “COVID-19 remains a real public health concern, and an increasing number of studies are showing the benefit of mucosal vaccines that attack the virus where it enters the body—through the nose and mouth—to give better and longer protection. We look forward to this important next step in potentially providing a more durable and safer option to help prevent infection and transmission of COVID-19 regarding various variants of concern.”

Even though the pandemic has ended, COVID-19 still presents a significant burden in the U.S. The Centers for Disease Control (CDC) estimates that from October 1, 2024 to January 11, 2025, there were 4.4 to 7.9 million COVID infections, resulting in 120,000 to 210,000 hospitalizations and 14,000 to 25,000 deaths.

The Phase 1 trial would enroll 80 adult subjects aged 18 to 64 years. Forty (40) subjects would be assigned to the low-dose group, and 40 subjects would be assigned to the high-dose group. Within each group, 20 subjects would receive the inhalation form of the vaccine, and the other 20 subjects would receive the intranasal form. The primary aim of the study would be to determine safety, while secondary and exploratory endpoints include antibody production and the number of breakthrough COVID-19 infections.

OCU500 is based on a novel chimpanzee adenovirus-vectored (ChAd36) technology. Earlier clinical studies to prevent COVID-19 that employed a similar technology administered via inhalation demonstrated increased mucosal and systemic antibodies and a durable immune response up to one year using one-fifth the dose compared to the same vaccine administered intramuscularly. Ocugen intends to expand this mucosal platform to address other serious respiratory threats including seasonal influenza, bird flu, and respiratory syncytial virus (RSV).

The original ChAd36 vector that makes the Ocugen vaccine unique was licensed from Washington University in St. Louis.

“We are delighted to see the progress of the ChAd36 vector encoding a SARS-CoV-2 spike antigen that was originally designed and tested at Washington University in St. Louis,” said Dr. Michael Diamond, Professor of Medicine and Co-Director of the Center for Vaccines and Immunity to Microbial Pathogens at Washington University School of Medicine. “We believe this vector is ideal for mucosal administration and can be designed to carry COVID-19 strains as well as influenza and antigens from other respiratory viruses,” added Dr. David Curiel, Professor of Radiation Oncology, Washington University School of Medicine, co-collaborator on the vector design. 

Project NextGen is a $5 billion multi-government agency initiative to develop the next generation of vaccines and therapeutics to combat the spread of COVID-19. NIAID, with funding from Project NextGen, will cover the full cost of the Phase 1 clinical trial, including operations and related analysis. Ocugen is providing clinical trial materials and, upon completion, will have full right of reference to the findings, which Ocugen believes will provide clinical evidence to support the further development of the Company’s lead mucosal vaccine candidate.

“Ocugen further advanced the vector technology, enabling the incorporation of single/multiple antigens into a single vector. This innovation offers significant manufacturing flexibility in responding to emerging variants within one hundred days of identifying a circulating variant of concern,” said Dr. Arun Upadhyay, Chief Scientific Officer at Ocugen. “This vector technology, combined with mucosal delivery, has the potential to enable rapid development of respiratory vaccines in response to future outbreaks including bird flu.”

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 X 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, including, but not limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, 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, including, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; the ability of OCU500 to perform in humans in a manner consistent with nonclinical or preclinical study data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. 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
Tiffany.Hamilton@ocugen.com

Novo Nordisk Stock Soars After Groundbreaking Results for New Obesity Drug

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Novo Nordisk’s amycretin led to 22% average weight loss in a 36-week trial.
– Shares rose 7.13%, marking the best single-day gain since March 2024.
– Amycretin targets dual hormones to tackle hunger and appetite, showcasing groundbreaking innovation.

Novo Nordisk shares surged Friday after the pharmaceutical giant announced promising early-stage trial results for amycretin, a groundbreaking weight-loss drug administered through a once-weekly injection. The Danish company revealed that the treatment led to an average weight reduction of 22% in overweight and obese patients over a 36-week trial, marking a significant advancement in the fight against obesity. This compares to a 2% weight gain observed in patients receiving a placebo, showcasing the drug’s potential to reshape the treatment landscape for weight management.

The trial involved 125 participants and highlighted amycretin’s innovative mechanism of action. The drug targets GLP-1, a gut hormone that regulates appetite, and amylin, a hormone produced by the pancreas that influences hunger. This dual-action approach is a step forward from Novo Nordisk’s flagship products, Wegovy, which mimics GLP-1, and Ozempic, its well-known diabetes treatment. Amycretin’s ability to address weight loss through multiple pathways underscores its potential to provide life-changing results for patients struggling with obesity.

Novo Nordisk’s stock rose by 7.13% on Friday, reaching its best single-day performance since March 2024. The initial gains peaked at nearly 14% before settling, reflecting strong investor confidence in the company’s ability to expand its market dominance in obesity therapeutics. Fellow Danish drugmaker Zealand Pharma also benefited from the announcement, with shares climbing 4.7%, while rival Eli Lilly, the maker of obesity drug Zepbound, saw a slight dip in premarket trading.

The pharmaceutical industry has been increasingly focused on developing more effective weight-loss solutions, with obesity affecting millions worldwide and posing significant health risks. Novo Nordisk’s continued innovation in this space has made it a frontrunner, and the results from the amycretin trial further solidify its position. The company is already exploring oral formulations of the drug, which, in a separate early-stage trial announced last September, demonstrated a 13.1% weight reduction over 12 weeks.

Safety and tolerability are key considerations for any obesity treatment, and amycretin appears to meet these benchmarks. The most common side effects observed during the trial were gastrointestinal issues, but most were mild to moderate in severity. These findings align with patient tolerability seen in previous trials for similar drugs, making amycretin a promising addition to Novo Nordisk’s portfolio.

Martin Lange, executive vice president for development at Novo Nordisk, expressed optimism about the trial results. “We are very encouraged by the subcutaneous phase 1b/2a results for amycretin in people living with overweight or obesity,” Lange said in a statement. “The results seen in the trial support the weight-lowering potential of this novel unimolecular GLP-1 and amylin receptor agonist.”

As Novo Nordisk invests further in amycretin, the drug has the potential to transform the obesity treatment market, which is projected to grow substantially in the coming years. The company’s strategic focus on innovative, science-driven solutions positions it to maintain a competitive edge while addressing a critical global health challenge.

Beta Bionics Unveils $112.5 Million IPO Terms, Pioneers Autonomous Insulin Delivery Technology

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Beta Bionics’ iLet Bionic Pancreas is the first FDA-approved device to autonomously determine insulin doses using adaptive algorithms.
– The company plans to raise $112.5 million by offering 7.5 million shares at a price range of $14-$16, achieving a potential market cap of $577.35 million.
– Beta Bionics is part of a surge in biotech IPOs, reflecting investor confidence in transformative medical technologies.

Beta Bionics, the California-based innovator behind the iLet Bionic Pancreas, disclosed plans for a $112.5 million IPO, marking a pivotal moment in healthcare technology. The IPO terms, filed on January 22, 2025, outline the offering of 7.5 million shares priced between $14.00 and $16.00. At the midpoint of $15.00 per share, the company would achieve a market cap of approximately $577.35 million. Trading is set to commence on January 30, 2025, under the proposed ticker symbol “BBNX” on the NASDAQ.

The iLet Bionic Pancreas represents a groundbreaking advancement in diabetes management, being the first FDA-approved insulin delivery device to use adaptive closed-loop algorithms. This innovation enables the device to autonomously determine every insulin dose without requiring users to count carbohydrates, offering a significant improvement in the quality of life for individuals with Type 1 diabetes (T1D).

T1D affects approximately 1.8 million people in the U.S., all of whom rely on daily insulin replacement. The iLet system, cleared by the FDA for patients aged six and older in May 2023, targets this market with a vision to transform diabetes care. Despite its groundbreaking potential, Beta Bionics is currently unprofitable, reporting a net loss of $55.4 million on $53.1 million in revenue for the 12 months ending September 30, 2024.

The IPO, led by BofA Securities, Piper Sandler, Leerink, and Stifel, will provide the funding necessary for Beta Bionics to expand commercialization efforts and further develop its innovative technology. This initiative positions the company at the forefront of the intersection between healthcare and technology, emphasizing the growing demand for automated and personalized solutions in chronic disease management.

Beta Bionics’ IPO is part of a broader trend highlighting the growing prominence of biotech companies in public markets. With the rapid advancements in medical technology and increasing regulatory approvals, the biotech sector has emerged as a key driver of innovation. Biotech IPOs have gained momentum, reflecting strong investor interest in companies addressing critical healthcare needs with cutting-edge solutions.

In particular, biotech firms are increasingly leveraging public funding to accelerate the development and distribution of transformative therapies and devices. The promise of addressing unmet medical needs, coupled with advancements in artificial intelligence and biotechnology, has fueled optimism in the sector. Companies like Beta Bionics exemplify how public markets can empower medical innovation to scale, potentially improving millions of lives.

Investors are drawn to biotech IPOs not only for their market potential but also for their societal impact, as these companies strive to tackle some of the world’s most pressing healthcare challenges. Beta Bionics’ iLet device is a prime example of this trend, offering a glimpse into the future of automated, patient-centric care.

Take a moment to take a look at more emerging growth healthcare companies by taking a look at Noble Capital Markets’ Research Analyst Robert LeBoyer’s coverage list.

Nutriband (NTRB) – Initiating Coverage With An Outperform Rating And $13 Price Target

Posted on by cpereira@noblefcm.com


Wednesday, January 22, 2025

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 With An Outperform Rating. Nutriband, Inc. is a pharmaceutical company developing transdermal patch technologies for drug delivery. Its proprietary technology, known as AVERSA, has abuse-deterrent features with important differences from other transdermal patches on the market. The lead product is AVERSA Fentanyl, an abuse-deterrent transdermal patch for delivering fentanyl that improves safety, compliance, and patient comfort.

Only One Clinical Trial Is Required For the 505 (b)(2) New Drug Application. AVERSA Fentanyl can follow the 505(b)(2) regulatory pathway with only a single Phase 1 clinical abuse potential study required to support the new label claims. We expect this study to begin in 1H25, announce results in 2H25, and file an NDA around YE2025 to early 2026.


Get the Full Report

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. 

GeoVax Labs (GOVX) – Gedeptin To Begin Phase 2 Clinical Trial

Posted on by cpereira@noblefcm.com


Tuesday, January 21, 2025

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.

GeoVax Starts The Year By Announcing Phase 2 Trial For Gedeptin. GeoVax has announced that a Phase 2 trial for Gedeptin, its gene therapy for delivering cytotoxic cancer drugs, is planned to start in 1H25. As we expected, the trial will test Gedeptin with a checkpoint inhibitor in patients with recurrent squamous cell carcinoma of the head and neck (SCCHN).

Gedeptin Delivers A Gene To Activate The Cancer Drug In The Tumor. Gedeptin is based on the Gene-Directed Enzyme Prodrug Therapy (GDEPT) technology platform. It uses an adenovirus vector to deliver the E. coli PNP gene to cancer cells. Once inside the cells, the gene produces an enzyme that converts an inactive prodrug (fludarabine) into an active cytotoxic drug. This increases the drug’s potency inside the cancer cells while avoiding healthy tissue. Gedeptin has completed Phase 1/2 trials in advanced head and neck cancer and has been granted Orphan Drug Designation for oral and pharyngeal cancers.


Get the Full Report

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 – Ocugen, Inc. Announces First Patient Dosed in Phase 1 Clinical Trial of OCU200—a Novel Integrin-Targeting Biologic for Diabetic Macular Edema

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

January 16, 2025

PDF Version

MALVERN, Pa., Jan. 16, 2025 (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 the first patient has been dosed in the OCU200 Phase 1 clinical trial for diabetic macular edema (DME).

“OCU200 has the potential to change the treatment landscape for DME, diabetic retinopathy (DR), and wet age-related macular degeneration (wet AMD) with its unique mechanism of action, binding the active component—tumstatin—to integrin receptors that play a crucial role in disease pathogenesis,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-Founder of Ocugen. “OCU200 holds the promise to benefit all DME patients, including the 30-40% of patients who do not respond to current anti-VEGF therapies.”

The OCU200 Phase 1 clinical trial is a multicenter, open-label, dose-escalation study to assess drug safety via intravitreal injection in three cohorts: low dose (0.025 mg), medium dose (0.05 mg), and high dose (0.1 mg). All subjects will receive a total of two intravitreal injections of OCU200 six weeks apart. Patient follow-up will take place up to three months after the last injection.

Approximately 12 million people in the United States and 130 million people worldwide are affected by DME, DR or wet AMD. Patients affected by these diseases share common symptoms, such as blurriness in vision and progressive vision loss as the disease progresses. The formation of fragile and leaky new blood vessels leads to fluid accumulation in and around the retina, causing damage to vision.

“I am seeing an increasing rate of vision-threatening diseases associated with diabetes at my clinic and am eager to provide a new therapeutic option to these patients,” said Dr. David Almedia, Vitreoretinal Surgeon and Clinician Scientist, President and CEO of Erie Retina Research, and Founder and President of Case X Global in Erie, Pennsylvania. “There remains a considerable unmet medical need for DME and DR patients with currently available anti-VEGF treatments.”

OCU200 is a recombinant fusion protein that consists of two parts connected by a linker: tumstatin, the active component, acts as an anti-inflammatory, anti-VEGF agent by binding to integrin receptors; and transferrin, which targets the drug to the choroid and retina by binding transferrin receptors on endothelial cells. These features will potentially enable OCU200 to reduce the vascular permeability, inflammation, and neovascularization that drive the pathophysiology of DME, DR, and wet AMD at a significantly lower dose compared to currently approved therapies.

“We are enthusiastic about getting patients started in the OCU200 Phase 1 clinical trial and sharing not only safety but preliminary efficacy data as the study progresses,” said Dr. Huma Qamar, Chief Medical Officer at Ocugen. “OCU200 brings an innovative biologic candidate to Ocugen’s ophthalmology portfolio targeting blindness diseases.”

The Company intends to pursue approval to use OCU200 as a first-line therapy for DME, DR, and wet AMD.

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 patients’ 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 X 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, including, but not limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, 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, including, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; the ability of OCU200 to perform in humans in a manner consistent with nonclinical or preclinical study data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. 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
Tiffany.Hamilton@ocugen.com

Release – GeoVax Announces Major Gedeptin® Milestone with Plans of Phase 2 Trial

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

Represents a Key Step Toward Validating Gedeptin Potential in Solid Tumor Therapy

Atlanta, GA, January 15, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing innovative immunotherapies and vaccines for cancer and infectious diseases, announced significant progress in advancing Gedeptin as a cancer therapy. Gedeptin, based on a Gene-Directed Enzyme Prodrug Therapy (GDEPT) platform, employs a targeted approach to deliver therapeutic agents directly to tumor sites. The result of this approach is the localized production of a potent anti-cancer agent(s) within the tumor microenvironment, while minimizing systemic exposure and the potential for associated side effects. 

Following a review of the data from the completed Phase 1 single-cycle and Phase 1/2 multi-cycle Gedeptin trials among patients with advanced Head & Neck (H&N) tumors, GeoVax has decided to initiate a Phase 2 clinical study, evaluating neoadjuvant Gedeptin therapy in combination with an approved immune check point inhibitor (ICI) in 1st recurrent H&N cancer scheduled for resection with curative intent.

Therapy Potential and Market Opportunity

Gedeptin has been granted Orphan Drug Designation by the U.S. FDA for the intratumoral treatment of anatomically accessible oral and pharyngeal cancers, underscoring its potential to address significant unmet medical needs.

“Preclinical data suggest that Gedeptin/fludarabine can enhance the activity of ICIs in treatment of solid tumors.  Our upcoming Phase 2 trial will investigate this approach as a neoadjuvant therapy for patients with first recurrence head and neck cancer. We believe this will lead to increased tumor response and decreased recurrence rates in these patients,” said David Dodd, Chairman and CEO of GeoVax. “Based on the data generated to date, this combination has the potential to address multiple solid tumor indications, and represents a significant medical and commercial opportunity, if approved.”

David Dodd added, “We are entering an exciting phase of clinical development with Gedeptin, and our team remains committed to advancing this innovative therapy to deliver life-changing benefits for cancer patients worldwide.”

Advancing Clinical Development

The upcoming Phase 2 trial will evaluate the efficacy of Gedeptin in combination with ICIs in patients with first-recurrence head and neck cancer. Key endpoints will include pathologic response rates and overall treatment outcomes. GeoVax plans to initiate trial activities mid-year and partner with leading academic oncology centers.

A Transformative Year Ahead

GeoVax projects significant milestones in 2025, with Gedeptin expected to play a key role in delivering transformative cancer therapies. Beyond head and neck cancers, the company plans to explore Gedeptin’s potential applications across other solid tumor types.

GeoVax’s CEO, David Dodd, will present the Company’s 2024 progress and outlook for 2025 at the Emerging Growth Conference: January 16, 2025, at 2:35 PM ET.

For more information on GeoVax’s portfolio and developments, please visit www.geovax.com.

About GeoVax

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

Forward-Looking Statements

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

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

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

Biotech Merger: Salarius and Decoy Unite to Advance AI-Driven Peptide Therapeutics

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Combined company to focus on ML/AI-powered drug development platform
– Decoy shareholders to own 86% of merged entity
– Pipeline includes treatments for respiratory viruses and GI cancers

In a strategic move to accelerate the development of next-generation therapeutics, Salarius Pharmaceuticals (NASDAQ: SLRX) announced today its merger with privately-held Decoy Therapeutics in an all-stock transaction. The combined company, which will operate under the Decoy Therapeutics name, aims to leverage artificial intelligence and machine learning to revolutionize peptide conjugate drug development.

The merger brings together Decoy’s proprietary IMP3ACT™ platform, which has already attracted approximately $7 million in non-dilutive funding from prestigious organizations including The Bill & Melinda Gates Foundation, with Salarius’ clinical-stage pipeline and public market presence. Under the terms of the agreement, Decoy shareholders will own approximately 86% of the combined company, with Salarius stockholders retaining the remaining 14%.

“Peptide conjugates have become one of the most important drug classes as measured by prescription rates and revenue growth,” said Rick Pierce, Decoy’s Co-founder and CEO, who will lead the combined company. “Our highly experienced team is excited to be able to unlock significant shareholder value from our IMP3ACT platform, which can rapidly design new peptide conjugate drugs by applying ML and AI tools.”

The merged entity’s immediate focus includes advancing a pan-coronavirus antiviral toward an FDA Investigational New Drug (IND) application within the next 12 months. Additionally, the company plans to develop a broad-acting antiviral targeting flu, COVID-19, and respiratory syncytial virus (RSV), as well as a peptide drug conjugate for gastrointestinal cancers.

David Arthur, Salarius’ CEO, emphasized the strategic rationale: “The compelling science supporting Decoy’s peptide conjugate technology and the company’s management team are truly impressive. Based on our diligence, we believe Decoy is poised to advance multiple drug candidates that address significant unmet needs in numerous therapeutic areas.”

The combined company will maintain Salarius’ ongoing Phase 1/2 clinical trial at MD Anderson Cancer Center while exploring strategic alternatives for its seclidemstat program. The merger has received unanimous approval from both companies’ boards of directors and is expected to close following customary closing conditions.

Release – GeoVax Achieves Significant Progress in Next-Generation COVID-19 Vaccine Development Throughout 2024

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

 Advancements Position GEO-CM04S1 as a Leading Vaccine Candidate Addressing Unmet Medical Needs, Especially Among Immunocompromised Patients

ATLANTA, GA, January 13, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company specializing in immunotherapies and vaccines against infectious diseases and cancers, is pleased to announce substantial progress in the clinical development of its COVID-19 vaccine portfolio during 2024. These achievements underscore the potential of GEO-CM04S1 to address critical public health needs, particularly among immunocompromised populations.

Project NextGen (PNG) Award

In June 2024, GeoVax received a significant award through the Rapid Response Partnership Vehicle (RRPV), funded by the Biomedical Advanced Research and Development Authority (BARDA) as part of PNG. This award supports a 10,000-participant Phase 2b clinical trial to evaluate the efficacy of GEO-CM04S1 compared to an approved COVID-19 vaccine. The study is set to commence in the second half of 2025, with Allucent, a global clinical research organization, selected to conduct and manage the trial.

Chronic Lymphocytic Leukemia (CLL) Interim Study Results

In November 2024, the Data Safety Monitoring Board (DSMB) for the ongoing Phase 2 clinical trial of GEO-CM04S1 as a booster vaccine for patients with CLL conducted an interim data review of the study. Following its review, the DSMB recommended that the study should continue enrollment of the experimental arm utilizing GEO-CM04S1, but that the mRNA control arm of the study should be halted as it failed to meet the predetermined primary immune endpoint. This suggests a potentially superior immune response in this vulnerable population. Further enrollment of the remaining patient participants is expected to be completed during 2025.

Completion of Enrollment in Booster Vaccine Study for Healthy Adult Volunteers

GeoVax has successfully completed enrollment in its Phase 2 clinical trial evaluating GEO-CM04S1 as a booster vaccine in healthy adults who previously received COVID-19 vaccines. This study aims to assess the vaccine’s safety and immunogenicity at two different dose levels, with data readouts anticipated in the first half of 2025.

Ongoing Stem Cell Transplant Study

The Company continues to advance its Phase 2 clinical trial of GEO-CM04S1 as a primary vaccine for immunocompromised patients undergoing stem cell transplantation. This study addresses a critical need for effective vaccination strategies in populations that may not respond adequately to existing vaccines.

Potential Benefits of GEO-CM04S1 Over Existing Authorized COVID-19 Vaccines

GEO-CM04S1 offers several potential benefits compared to currently authorized COVID-19 vaccines:

  • Public Health Impact: By providing robust protection for immunocompromised individuals, GEO-CM04S1 could significantly reduce COVID-19-related risks of morbidity and mortality among such high-risk patient populations.
  • Durability: Preliminary data suggest that GEO-CM04S1 may offer longer-lasting immunity, potentially reducing the frequency of booster doses required.
  • Breadth of Protection: The inclusion of both Spike (S) and Nucleocapsid (N) antigens in GEO-CM04S1 may confer broader immunity, making it more effective against a range of variants without the need for frequent reformulation.
  • Primary Vaccine for Immunocompromised Patients: With approximately 40 million immunocompromised individuals in the U.S. and an estimated 400+ million worldwide, many of whom may not respond adequately to current vaccines, GEO-CM04S1 has the potential to become the preferred vaccine for this population.
  • Safety. The safety profile of MVA as the platform for GEO-CM04S1 is well-established, with decades of data supporting its use as a smallpox vaccine, as well as its use as a platform with diverse vaccine candidates. This robust safety record is particularly important as the new HHS administration prioritizes transparency and rigorous oversight in vaccine safety evaluation. GEO-CM04S1 aligns with these priorities, offering a scientifically validated platform backed by comprehensive safety data.

Market Potential and Partnering Opportunities

GEO-CM04S1 offers an alternative approach to boosting existing COVID-19 vaccines, providing enhanced and more durable immunity. Its applicability for immunocompromised patients further broadens its public health and commercial value. GeoVax estimates the annual market potential for GEO-CM04S1 to be approximately $30 billion, reflecting the critical medical need to better address high-risk immunocompromised patients. The global need for a next-generation COVID-19 vaccine with the advantages offered by GEO-CM04S1 creates multiple partnering opportunities for GeoVax.

Looking Ahead to 2025

The continued development of GEO-CM04S1 is a key component of GeoVax’s catalyst-rich agenda for 2025. The Company anticipates multiple data readouts and regulatory milestones that will further define the vaccine’s role in combating COVID-19.

“Our progress in 2024 has been remarkable, particularly in advancing GEO-CM04S1 as a next-generation COVID-19 vaccine,” said David Dodd, Chairman & CEO of GeoVax. “The MVA platform underlying our vaccine offers unique advantages, including the potential for broader and more durable protection, which is especially critical for immunocompromised individuals. We are committed to delivering solutions that address unmet medical needs and improve public health outcomes.”

Upcoming Presentations

GeoVax’s CEO, David Dodd, will present the Company’s 2024 progress and future outlook at the following conferences:

  • Biotech Showcase: January 14, 2025, at 10:30 AM PST
  • Emerging Growth Conference: January 16, 2025, at 2:35 PM ET

For more information on GeoVax’s portfolio and developments, please visit www.geovax.com

About GeoVax

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

Forward-Looking Statements

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

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

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

Release – Eledon Pharmaceuticals Highlights Recent Business Milestones and Provides 2025 Outlook

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ELDN

January 13, 2025

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Completed enrollment in Phase 2 BESTOW trial assessing tegoprubart in kidney transplantation four months ahead of schedule; on track to report topline results in fourth quarter of 2025

Presented updated data on 13 participants from ongoing Phase 1b trial that continue to support safety and tolerability of tegoprubart for prevention of organ rejection in kidney transplantation

Announced positive initial data from first three subjects with type 1 diabetes treated with tegoprubart as part of immunosuppression regimen following islet transplantation in investigator-initiated trial at UChicago Medicine

Completed two financings totaling $135 million in combined gross proceeds, with funds expected to support operations through end of 2026

IRVINE, Calif., Jan. 13, 2025 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today announced a summary of 2024 accomplishments and provided guidance for anticipated 2025 business milestones.

“2024 was a transformative year for Eledon as we achieved multiple key clinical milestones for tegoprubart across kidney, islet cell, and xenograft transplantation,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “Moreover, the data we reported reinforced the potential of tegoprubart to be a best-in-class immunosuppression therapy to prevent transplant rejection and disrupt the current standard of care. We now look forward to another pivotal year ahead.”

2024 Key Highlights

  • Completed enrollment of 120 patients in the Phase 2 BESTOW clinical trial approximately four months earlier than originally planned. The Phase 2 trial is designed to assess the safety and efficacy of tegoprubart for the prevention of organ rejection in patients undergoing kidney transplantation.
  • Presented updated data at the American Transplant Congress (ATC) from the ongoing Phase 1b open-label trial evaluating tegoprubart for the prevention of organ rejection in kidney transplant patients. Updated data from 13 participants demonstrated that tegoprubart was generally safe and well tolerated, with an overall mean estimated glomerular filtration rate (eGFR) of 70.5 mL/min/1.73m2 at all reported time points after day 30 post-transplant. Two participants completed more than 12 months on therapy post-transplant, and both demonstrated mean eGFRs above 90 mL/min/1.73m2 at one-year post-transplant.
  • Announced positive initial data for the first three islet transplant recipients treated with tegoprubart as part of an immunosuppression regimen for the prevention of islet transplant rejection in subjects with type 1 diabetes in an investigator-initiated trial at the University of Chicago Medicine’s Transplant Institute. The data demonstrated potentially the first human cases of insulin independence achieved using an anti-CD40L monoclonal antibody immunosuppression therapy without the use of tacrolimus, the current standard of care for prevention of transplant rejection.
  • Announced the use of tegoprubart as part of the immunosuppression treatment regimen used following the first-ever kidney xenotransplant procedure of a genetically modified pig kidney to a human.
  • Completed two financings for combined total gross proceeds of $135.0 million, before deducting any offering related expenses, which is anticipated to support company operations to the end of 2026.

Anticipated 2025 Milestones

  • Summer 2025: Report updated interim clinical data from the ongoing Phase 1b and long-term efficacy extension studies of tegoprubart in kidney transplantation.
  • 4Q 2025: Report topline results from the Phase 2 BESTOW trial of tegoprubart in kidney transplantation.
  • 2025: Report longer-term follow up results from the investigator-led clinical trial at UChicago Medicine Transplant Institute for pancreatic islet transplantation in subjects with type 1 diabetes involving use of tegoprubart as part of immunosuppression regimen.

About Eledon Pharmaceuticals and tegoprubart

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

Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about planned clinical trials, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, the company’s capital resources and ability to finance planned clinical trials, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical 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
stephen@gilmartinir.com

Media Contact:

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

Source: Eledon Pharmaceuticals

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Source: Eledon Pharmaceuticals, Inc.