GeoVax Labs is making significant strides in the development of GEO-CM04S1, a next-generation COVID-19 vaccine, with promising results from ongoing Phase 2 clinical trials. The vaccine is particularly aimed at addressing the unmet medical needs of immunocompromised patients, who often exhibit suboptimal responses to currently authorized vaccines.
BARDA Support and Phase 2b Trial
In June 2024, GeoVax received a substantial award through the Rapid Response Partnership Vehicle (RRPV), funded by the Biomedical Advanced Research and Development Authority (BARDA) as part of Project NextGen (PNG). This funding supports a 10,000-participant Phase 2b clinical trial designed to evaluate the efficacy of GEO-CM04S1 in comparison to an approved COVID-19 vaccine. The trial is scheduled to begin in the second half of 2025, with Allucent, a global clinical research organization, managing the trial.
Interim Results in Chronic Lymphocytic Leukemia (CLL) Patients
An interim data review by the Data Safety Monitoring Board (DSMB) of the Phase 2 clinical trial of GEO-CM04S1 as a booster vaccine for patients with Chronic Lymphocytic Leukemia (CLL) yielded encouraging results. The DSMB recommended continuing enrollment in the experimental arm utilizing GEO-CM04S1 while halting the mRNA control arm due to its failure to meet the predetermined primary immune endpoint. This suggests a potentially superior immune response in this vulnerable population.
Booster Vaccine Study in Healthy Adults
GeoVax has completed enrollment in its Phase 2 clinical trial evaluating GEO-CM04S1 as a booster vaccine in healthy adults who previously received COVID-19 vaccines. The 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.
Stem Cell Transplant Study
The company is also advancing its Phase 2 clinical trial of GEO-CM04S1 as a primary vaccine for immunocompromised patients undergoing stem cell transplantation, addressing a critical need for effective vaccination strategies in this population.
Potential Advantages of GEO-CM04S1
GEO-CM04S1 offers several potential benefits compared to currently authorized COVID-19 vaccines:
- Public Health Impact: Robust protection for immunocompromised individuals could significantly reduce COVID-19-related morbidity and mortality.
- Durability: Preliminary data suggest potentially longer-lasting immunity, reducing the frequency of required booster doses.
- Breadth of Protection: Inclusion of both Spike (S) and Nucleocapsid (N) antigens may confer broader immunity, making it more effective against a range of variants without frequent reformulation.
- Primary Vaccine for Immunocompromised Patients: With a large population of immunocompromised individuals who may not respond adequately to current vaccines, GEO-CM04S1 has the potential to become the preferred vaccine for this group.
- Safety: The MVA platform's safety profile, with decades of data supporting its use, is a significant advantage.
Market Potential
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.
According to David Dodd, Chairman & CEO of GeoVax, "Our progress in 2024 has been remarkable, particularly in advancing GEO-CM04S1 as a next-generation COVID-19 vaccine. 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."
