GeoVax Retains CATO SMS to Manage Two Phase 2 COVID-19 Vaccine Clinical Trials

Rhea-AI Summary

GeoVax Labs, Inc. (Nasdaq: GOVX) announced a partnership with CATO SMS for managing its two ongoing Phase 2 clinical trials of the COVID-19 vaccine candidate GEO-CM04S1. This synthetic vaccine aims to induce robust immune responses targeting both spike and nucleocapsid proteins. The first trial compares GEO-CM04S1's safety and immunogenicity to the Pfizer/BioNTech vaccine in immunocompromised patients, while the second trial evaluates GEO-CM04S1 as a booster for individuals previously vaccinated with Pfizer/BioNTech or Moderna vaccines. The company believes this dual-targeting approach may enhance protection against variants.

Positive

• Engagement of CATO SMS for managing clinical trials may streamline operations and expedite enrollment.
• GEO-CM04S1 is unique as it targets both S and N proteins, potentially offering greater immunity against variants.
• Ongoing Phase 2 trials will provide critical data on safety and immunogenicity in immunocompromised patients.

Negative

• The reliance on clinical trial results poses risks; FDA approval is uncertain and dependent on trial outcomes.
• Notable competition from established mRNA vaccines like Pfizer/BioNTech and Moderna could impact market acceptance.

• Comparative Trial Against Pfizer/BioNTech Vaccine Among Immunocompromised Patients
• Booster to Pfizer/BioNTech or Moderna Vaccines Among Healthy Patients

ATLANTA, GA, March 14, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company specializing in developing human vaccines and cancer immunotherapies, today announced the engagement of 

CATO SMS to manage GeoVax’s two ongoing Phase 2 clinical trials of its vaccine candidate, GEO-CM04S1, against SARS-CoV-2.

GEO-CM04S1 is a synthetic, non-replicating modified vaccinia Ankara (MVA) vaccine vector, developed as a double recombinant vectored vaccine to stimulate potent humoral and cellular immune responses against both the spike (S) and nucleocapsid (N) proteins of the SARS-CoV-2 virus. Upon immunization, the vaccine vector infects cells at the local injection site, leading to the expression of the SARS-CoV-2 antigens that are visible to the immune system. GeoVax believes GEO-CM04S1 will provide additional recognition elements to the immune system over a homologous boost from mRNA vaccines alone, such as those developed by Moderna or Pfizer/BioNTech, which are directed only toward the S protein. The GEO-CM04S1 vaccine’s MVA backbone may also be more effective at inducing COVID-19 immunity since MVA is known to strongly induce T cell responses even in a background of immunosuppression. In addition, GEO-CM04S1 targeting of both S and N antigens may offer greater protection and durability against the significant sequence variation observed with the S antigen among variants of concern such as Omicron.

GEO-CM04S1 for Immunocompromised Patients – GEO-CM04S1 is being studied in an ongoing Phase 2 clinical trial (NCT04977024) to evaluate its safety and immunogenicity, compared to the Pfizer/BioNTech mRNA-based vaccine, in patients who have previously received either an allogeneic hematopoietic cell transplant, an autologous hematopoietic cell transplant or chimeric antigen receptor (CAR) T cell therapy. GEO-CM04S1 is the only COVID-19 vaccine that includes both SARS-CoV-2 spike and nucleocapsid proteins to advance to a Phase 2 trial in cancer patients. Such vaccines tend to produce an immune response quickly – in less than 14 days – with only mild side effects. The trial is also the first to compare an investigational multi-antigenic COVID-19 vaccine to the current Food and Drug Administration (FDA)-approved mRNA vaccine from Pfizer/BioNTech in people who are immunocompromised. Such patients have often shown a weak antibody response after receiving currently available COVID-19 vaccines. 

GEO-CM04S1 as a Booster Vaccine – In December 2021, patient enrollment began for the Phase 2 portion of a Phase 1/2 trial (NCT04639466) of GEO-CM04S1, evaluating its use as a universal booster vaccine to current FDA-approved two-shot mRNA vaccines from Pfizer/BioNTech and Moderna. The Phase 1 portion of the trial is completed and was designed as a dose-escalation safety study in healthy individuals who had not been previously infected with SARS-CoV-2. The Phase 2 booster study, for which vaccination is ongoing, includes healthy individuals who were previously fully vaccinated with either the Pfizer/BioNTech or Moderna vaccine. The study is designed as a dose-escalation trial to specifically evaluate the safety profile and immunogenicity of COH04S1 as a booster. The immunological responses measured throughout the study will include the level of SARS-CoV-2 neutralizing antibodies against SARS-CoV-2 variants of concern (VOC), including the newly identified Omicron VOC, as well as specific T-cell responses.

David Dodd, GeoVax President and CEO, commented, “We are excited to have engaged CATO SMS as our CRO partner for our advancing clinical studies of GEO-CM04S1. CATO SMS brings deep experience in the area of infectious disease including managing COVID-19 clinical trials. We previously announced the engagement of CATO to manage our Phase1/2 trial of Gedeptin® therapy in patients with recurrent head and neck squamous cell carcinoma (HNSCC), and now look forward to working with them for our COVID-19 vaccine trials as well to achieve important clinical milestones including the expansion of clinical sites and acceleration of patient enrollment and evaluation.”

About CATO SMS

CATO SMS is a global provider of clinical research solutions, including strategic consulting, full-service clinical trial operations, biometrics, and clinical pharmacology. With more than 30 years of experience focusing on the needs of small and emerging biopharmaceutical companies, CATO SMS effectively designs and executes studies ⁠— from strategy to approval ⁠— in complex indications and modalities across a variety of therapeutic areas with a proven center of excellence in oncology. CATO SMS’ regulatory, therapeutic and operational expertise enables the company to meet goals and exceed expectations. Visit CATO-SMS.com for more information.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing human vaccines and immunotherapies against infectious diseases and cancer using novel proprietary platforms. GeoVax’s product pipeline includes two ongoing Phase 2 clinical trials of GEO-CM04S1 (formerly COH04S1) for COVID-19 as a universal booster vaccine to mRNA vaccines authorized by the U.S. Food and Drug Administration (FDA) and as a primary vaccine for use in immunocompromised patients. In addition to GEO-CM04S1 for COVID-19, GeoVax is developing GEO-CM02 as a pan-coronavirus vaccine. The Company is also conducting a Phase 1/2 clinical trial of Gedeptin® for treatment of head and neck cancer. Gedeptin® has been granted orphan drug status by the FDA. Additional research and development programs include preventive vaccines against Zika Virus, hemorrhagic fever viruses (Ebola, Sudan, Marburg, and Lassa) and malaria, as well as immunotherapies for multiple solid tumors. The Company’s portfolio of wholly owned, co-owned, and in-licensed intellectual property stands at over 70 granted or pending patent applications spread over 20 patent families.

For additional information about GeoVax, 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 preventive 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 preventive vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventive vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventive 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 registration statement on Form S-1 and the 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 U.S. federal securities law. 

Contact:
GeoVax Labs, Inc.
investor@geovax.com 
678-384-7220

FAQ

What is the purpose of GeoVax's GEO-CM04S1 vaccine?

The GEO-CM04S1 vaccine aims to induce a robust immune response against both SARS-CoV-2 spike and nucleocapsid proteins, targeting effectiveness in immunocompromised patients and serving as a booster for individuals vaccinated with mRNA vaccines.

What are the key trials involving GEO-CM04S1?

GEO-CM04S1 is involved in two Phase 2 clinical trials: one comparing its safety to the Pfizer/BioNTech vaccine in immunocompromised patients and another evaluating its use as a booster for those vaccinated with Pfizer/BioNTech or Moderna.

What are the expected outcomes of the Phase 2 trials for GEO-CM04S1?

The trials aim to establish the safety and immunogenicity of GEO-CM04S1, potentially leading to improved vaccination strategies for both immunocompromised patients and as a booster for others.

How does GEO-CM04S1 differ from existing COVID-19 vaccines?

GEO-CM04S1 uniquely targets both spike and nucleocapsid proteins, which may enhance immune response compared to current mRNA vaccines that focus solely on the spike protein.

What are potential market implications for GeoVax following these trials?

Successful trial results could position GeoVax favorably against established competitors in the COVID-19 vaccine market, particularly if it demonstrates superior efficacy in immunocompromised populations.