GeoVax Reports Positive Interim Data From Phase 2 Clinical Trial of GEO-CM04S1 as a Universal Covid-19 Vaccine Booster

Rhea-AI Summary

GeoVax Labs, Inc. announces positive initial safety and immune response findings from its Phase 2 clinical trial for its Covid-19 vaccine, GEO-CM04S1. The trial, evaluating GEO-CM04S1 as a heterologous booster in 63 healthy adults who had previously received the Pfizer or Moderna mRNA vaccine, showed no serious adverse events and documented statistically significant increases in neutralizing antibody responses against multiple SARS-CoV-2 variants, including Delta and Omicron XBB 1.5. GEO-CM04S1 is designed to induce both antibody and T-cell responses to protect against severe disease caused by continually emerging variants of Covid-19.

Insights

Medical Research Analyst

The recent findings from GeoVax Labs regarding their Phase 2 clinical trial of GEO-CM04S1 vaccine present a significant advancement in the ongoing battle against COVID-19. The data indicates a robust immune response, suggesting that the vaccine may offer protection against a broad spectrum of SARS-CoV-2 variants. This is particularly noteworthy given the rapid mutation rate of the virus and the global reliance on vaccines as a primary defense mechanism.

From a medical research perspective, the use of the MVA viral vector platform is a strategic choice, as it allows for the presentation of multiple antigens, potentially leading to a more comprehensive immune response. The encoding for both spike (S) and nucleocapsid (N) antigens is designed to induce antibody and T-cell responses to virus components that are less prone to mutation, which could result in longer-lasting immunity and reduce the need for frequent booster shots.

The absence of serious adverse events aligns with the safety profiles of other vaccines, which is reassuring for public health. Furthermore, if the vaccine proves effective in inducing long-term immunity, it could alleviate the strain on healthcare systems by reducing the frequency of vaccinations required to maintain protective immunity.

Financial Analyst

GeoVax Labs' announcement about their COVID-19 vaccine candidate's positive initial safety and immune response findings could have a substantial impact on their financial outlook and stock valuation. Investors will likely view the progress of the GEO-CM04S1 vaccine as a potential growth driver, especially if the vaccine can address the limitations of current vaccines by providing broader and more durable protection against emerging variants.

Given the competitive landscape of COVID-19 vaccines, GeoVax's success in clinical trials could position the company as a key player in the market. The ability to offer a next-generation vaccine that does not require frequent updates could give GeoVax a competitive advantage. The market will closely monitor the ongoing trial results and regulatory milestones, which will play a crucial role in determining the company's future revenue streams and market share.

It is essential to note, however, that the vaccine’s commercial success will depend on various factors, including the final clinical trial outcomes, regulatory approvals, production capabilities and market acceptance. As the vaccine development progresses, these factors will become critical in shaping the company's financial trajectory.

Epidemiologist

The development of GEO-CM04S1 as a heterologous booster is a strategic response to the dynamic nature of the SARS-CoV-2 virus. Epidemiologically, the ability to provide immunity against multiple variants is crucial in managing the pandemic. The statistically significant increases in neutralizing antibody responses against variants ranging from the original Wuhan strain to the Omicron XBB 1.5, as reported, suggest a promising outlook for the containment of the virus.

The potential for GEO-CM04S1 to protect against severe disease caused by emerging variants could prove to be a game-changer in public health policy and vaccine distribution strategies. The focus on T-cell responses, in addition to antibody responses, is indicative of a more holistic approach to vaccine design, which could lead to better outcomes in terms of reducing transmission, morbidity and mortality associated with COVID-19.

Continued surveillance and monitoring of the virus' evolution, alongside vaccine efficacy studies, will be imperative to ensure that the vaccine remains effective against new strains that may arise. The ongoing research and development in this field are critical for informing public health decisions and vaccination strategies on a global scale.

Results Demonstrate Potential Protective Immunity Against Multiple SARS-CoV-2 Variants

ATLANTA, GA, Feb. 06, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced positive initial safety and immune response findings from its Phase 2 clinical trial at one month following administration of its Covid-19 vaccine, GEO-CM04S1. The trial, evaluating GEO-CM04S1 as a heterologous booster in 63 healthy adults who had previously received the Pfizer or Moderna mRNA vaccine (ClinicalTrials.gov Identifier: NCT04639466), was fully enrolled at the end of Sept 2023.

The study is designed to evaluate the safety and immunogenicity of two GEO-CM04S1 dose levels. The trial remains blinded to dose of vaccine received, with study subjects being followed for a total of one year. To date, there have been no serious adverse events, and adverse events were in line with other routine vaccinations. The immunological responses measured throughout the study period include both neutralizing antibodies against SARS-CoV-2 variants and specific T-cell responses. Consolidated data from all subjects tested one-month post-vaccination, documented statistically significant increases in neutralizing antibody responses against multiple SARS-CoV-2 variants, ranging from the original Wuhan strain through Delta and Omicron XBB 1.5; additional testing against the JN.1 variant is underway.

GEO-CM04S1 is a next-generation Covid-19 vaccine based on GeoVax’s MVA viral vector platform, which supports the presentation of multiple vaccine antigens to the immune system in a single dose. 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. These latest findings lend support to previously published findings in cell transplant patients of the ability of GEO-CM04S1 to stimulate functional antibody responses against a broad array of evolving SARS-CoV-2 virus variants (Chiuppesi et al, Vaccines, Sept 2023).

Kelly McKee, Jr., MD, MPH, GeoVax Chief Medical Officer, stated, “There is a critical need to address the recognized shortcomings of currently approved SARS-CoV-2 vaccines. Annual (or even more frequent) vaccination in a seemingly never-ending race to keep pace with this rapidly evolving virus is an unsustainable strategy. GEO-CM04S1 continues to demonstrate the ability to elicit broadly reactive functional antibodies in conjunction with robust and durable T-cell responses, offering the prospect of a next-generation solution to address these shortcomings.”

“We are thrilled by these data and our investigational vaccine designed to protect against severe disease caused by emerging variants of Covid-19,” said David Dodd, GeoVax Chairman and CEO. “These interim data reinforce our resolve to bring our expertise in the development of innovative vaccines to address critical public health needs using new approaches and technologies. We look forward to providing further updates regarding the successful progress of the clinical development of GEO-CM04S1.”

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. 

Company Contact:		Investor Relations Contact:		Media Contact:
info@geovax.com		paige.kelly@sternir.com		sr@roberts-communications.com
678-384-7220		212-698-8699		202-779-0929

FAQ

What is the latest positive finding from GeoVax Labs, Inc.'s Phase 2 clinical trial for its Covid-19 vaccine, GEO-CM04S1?

The latest positive finding is that there have been no serious adverse events, and statistically significant increases in neutralizing antibody responses against multiple SARS-CoV-2 variants, including Delta and Omicron XBB 1.5, were documented.

What is the purpose of GEO-CM04S1, the Covid-19 vaccine developed by GeoVax Labs, Inc.?

GEO-CM04S1 is designed to induce both antibody and T-cell responses to protect against severe disease caused by continually emerging variants of Covid-19.

What is the design of GEO-CM04S1, the Covid-19 vaccine developed by GeoVax Labs, Inc.?

GEO-CM04S1 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. It 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.