Progress on GeoVax’s Universal Coronavirus Vaccine Candidate, GEO-CM02, Presented at Vaccines Summit 2023

Single-Dose Protection Demonstrated Against Multiple SARS-CoV-2 Variants

ATLANTA, GA, Nov. 14, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced the presentation of preclinical vaccine efficacy data for GEO-CM02, a multi-antigen investigational SARS-CoV-2 vaccine. The data were presented during the Vaccines Summit 2023 conference, being held in Boston, MA on November 13-15, 2023. The presentation, titled “MVA-vectored multi-antigen COVID-19 vaccines induce protective immunity against SARS-CoV-2 variants spanning Alpha to Omicron in preclinical animal models,” was delivered by Mukesh Kumar, PhD, Associate Professor, Department of Biology, Georgia State University.

“We are thrilled to continue to demonstrate the robust efficacy profile of GEO-CM02 with the presentation of preclinical data at this year’s Vaccine Summit,” said David Dodd, GeoVax’s Chairman and CEO. “Together, these data indicate that immunization with the multi-antigen GEO-CM02 vaccine can protect against severe disease and death induced by SARS-CoV-2 infection and regardless of the variant. Along with a demonstrated safety profile, we believe GEO-CM02 has potential as a transformative universal coronavirus vaccine.”

First-generation SARS-CoV-2 vaccines based on the spike (S) protein have demonstrated that they induce neutralizing antibodies, providing effective, albeit short-term levels of immune protection. Unfortunately, with the existing authorized vaccines, efficacy is disrupted by emerging variants that contribute to neutralizing antibody evasion, requiring continuous updating and booster doses. To address this limitation, GeoVax is currently evaluating its dual antigen COVID-19 vaccine, GEO-CM04S1 in three Phase 2 clinical trials.  GEO-CM04S1 encodes for both the spike (S) and nucleocapsid (N) antigens of SARS-CoV-2 and is specifically designed to induce both antibody and T cell responses to those parts of the virus less likely to mutate over time. The more broadly functional engagement of the immune system is designed to protect against severe disease caused by continually emerging variants of COVID-19. Vaccines of this format should not require frequent and repeated modification or updating. Moreover, GEO-CM04S1 is being developed specifically as a COVID-19 vaccine in support of patients with compromised immune systems, for whom the current authorized vaccines appear inadequate in providing protective immunity.

GEO-CM02 is a multi-antigen SARS-CoV-2 vaccine, based on the S, membrane (M), and envelope (E) proteins, which are designed to also engage both the humoral (antibody) and cellular (T-cell) arms of the immune system and to broaden both the function and specificity, potentially as a universal coronavirus vaccine. Efficacy of this investigational vaccine was tested using the industry standard, lethal hACE2 transgenic mouse model.

Data highlights from the Vaccine Summit 2023 presentation are as follows:

• The GEO-CM02 vaccine induced immune responses that were efficacious against the original Wuhan strain and BA.1 Omicron variant with a single dose.
• Animals were protected prior to the detection of neutralizing antibodies, likely indicating a critical T-cell contribution.
• GEO-CM02 significantly reduced or eliminated inflammation and immunopathology in the lungs of vaccinated animals.

The data generated in the GEO-CM02 studies validate GeoVax’s hypothesis that vaccines designed to induce both antibodies and T-cells to multiple viral structural proteins can address the issue of viral variation and escape from the immune system. GEO-CM02 is based on GeoVax’s MVA viral vector platform, which supports the presentation of multiple vaccine antigens to the immune system in a single dose.

GeoVax’s more advanced, next-generation COVID-19 vaccine, GEO-CM04S1, is being evaluated in three ongoing Phase 2 clinical trials:

• As a primary vaccine in immunocompromised patients (with hematologic cancers receiving cell transplants or CAR-T therapy). ClinicalTrials.gov Identifier: NCT04977024. GeoVax recently announced clinical site expansion for this trial.
• As a booster vaccine in immunocompromised patients with chronic lymphocytic leukemia (CLL), a recognized high-risk group for whom current mRNA vaccines and monoclonal antibody (MAb) therapies appear inadequate relative to providing protective immunity. ClinicalTrials.gov Identifier: NCT05672355.
• As a booster vaccine for healthy patients who have previously received the Pfizer or Moderna mRNA vaccine. ClinicalTrials.gov Identifier: NCT04639466. GeoVax recently announced that this trial has fully enrolled.

About GeoVax

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