GeoVax's COVID-19 Vaccine Shows Superior T-Cell Response in Leukemia Patients, Prompting Trial Arm Discontinuation
TL;DR
GeoVax's GEO-CM04S1 vaccine outperforms Pfizer-BioNTech's mRNA vaccine in immunocompromised patients, offering a competitive edge in the $30B+ market for vulnerable populations.
GEO-CM04S1 uses a dual-antigen MVA platform to generate durable T-cell responses, meeting primary endpoints in Phase 2 trials with 40% efficacy versus 14.3% for mRNA vaccines.
This vaccine addresses a critical gap for 40 million immunocompromised Americans and 400 million globally who remain vulnerable despite first-generation COVID-19 vaccines.
GeoVax's vaccine achieved 10-fold higher nucleocapsid-specific T-cell activation than mRNA vaccines, with responses maintained through 180 days in leukemia patients.
Found this article helpful?
Share it with your network and spread the knowledge!
GeoVax Labs, Inc. announced the publication of interim Phase 2 clinical data showing its next-generation COVID-19 vaccine, GEO-CM04S1, generated significantly stronger and more durable SARS-CoV-2–specific T-cell responses than BNT162b2 in patients with chronic lymphocytic leukemia. The findings, published in the British Journal of Haematology, led the trial's Data and Safety Monitoring Board to discontinue the comparator arm after the mRNA vaccine failed to meet the primary immunogenicity endpoint, with enrollment now proceeding exclusively with GEO-CM04S1.
The study involved CLL patients previously vaccinated with mRNA vaccines, with 27 evaluable for primary analysis. GEO-CM04S1 achieved superior T-cell responses, with 40% of recipients meeting the primary endpoint of a greater than or equal to 3-fold rise in antigen-specific IFN-y-secreting T cells at Day 56, compared to 14.3% for BNT162b2. The vaccine also demonstrated durable activation of nucleocapsid-specific T cells, with approximately 10-fold higher N-specific CD4 T-cell activation versus BNT162b2, and responses maintained through Day 180.
Kelly T. McKee, MD, MPH, Chief Medical Officer, stated that these results demonstrate GEO-CM04S1's ability to address the immune limitations of CLL patients by inducing strong, durable T-cell responses to both spike and nucleocapsid proteins of SARS-CoV-2. The DSMB's decision to discontinue the comparator arm further validates the vaccine's clinical relevance for immunocompromised individuals.
David Dodd, Chairman & CEO, added that with more than 40 million immunocompromised Americans and 400 million globally, many of whom lack durable protection from first-generation vaccines, GEO-CM04S1 represents a purpose-built solution for high-risk patients. This peer-reviewed publication strengthens the company's regulatory and partnering strategy as it advances toward potential commercialization.
The medical significance of these findings lies in addressing a critical unmet need for immunocompromised individuals who remain vulnerable and suboptimally protected from SARS-CoV-2. GEO-CM04S1's dual-antigen design stimulates immune responses that appear to be more durable and variant-resilient than single-antigen mRNA approaches. The company's lead clinical program is evaluating GEO-CM04S1 in multiple Phase 2 trials, including as a primary vaccine for immunocompromised individuals and as a booster for CLL patients. For more information about the current status of clinical trials and other updates, visit https://www.geovax.com.
Curated from NewMediaWire
