GeoVax's Multi-Antigen COVID-19 Vaccine Shows Superior Immune Response in CLL Patients Compared to mRNA Vaccines

GeoVax Labs, Inc. showcased positive interim Phase 2 results for its COVID-19 vaccine candidate GEO-CM04S1 at the International Workshop on Chronic Lymphocytic Leukemia conference, revealing superior performance compared to standard mRNA vaccines in immunocompromised patients. The data presented by Dr. Alexey V. Danilov from City of Hope demonstrated that GEO-CM04S1 met the study's primary immune endpoint in chronic lymphocytic leukemia patients, while the mRNA comparator arm did not achieve statistical significance, leading to the trial continuing enrollment exclusively in the GEO-CM04S1 arm following Data Safety Monitoring Board recommendations.

The significance of these findings lies in addressing a substantial unmet medical need for millions of immunocompromised patients worldwide who remain inadequately protected by current COVID-19 vaccines. Chronic lymphocytic leukemia patients represent a particularly vulnerable population where first-generation vaccines often fail to provide sufficient protection. GEO-CM04S1's multi-antigen approach, built on a Modified Vaccinia Ankara vector platform, encodes both the Spike and Nucleocapsid proteins of SARS-CoV-2, enabling broader and more durable immune protection compared to single-antigen mRNA products.

David Dodd, Chairman and CEO of GeoVax, emphasized that these results validate the company's platform technology while addressing a compelling commercial opportunity in a multi-billion dollar market segment. The vaccine's favorable safety profile, with no grade 3 or higher adverse events reported, further supports its potential clinical utility. The ongoing Phase 2 trial (NCT05672355) continues to evaluate GEO-CM04S1 across multiple patient populations, including as a primary vaccine for immunocompromised patients with blood cancers or post-transplant status, as a booster in CLL patients, and as a more robust COVID-19 booster in previously mRNA-vaccinated healthy adults.

The strategic importance of this development extends beyond immediate clinical applications, positioning GeoVax to lead in a market segment where durable protection remains elusive. The company's strong intellectual property portfolio and regulatory progress, including recent EMA guidance allowing progression directly to Phase 3 evaluation for their Mpox and smallpox vaccine candidate, further underscore the broader implications of their platform technology. For additional information about GeoVax's clinical programs, visit https://www.geovax.com.