GeoVax Labs, Inc. announced the publication of data from the ongoing Phase 2 trial of its next-generation COVID-19 vaccine (GEO-CM04S1) in the journal Vaccines. The article, authored by researchers at the City of Hope National Medical Center, can be accessed here: GEO-CM04S1 Publication. The Phase 2 clinical trial is evaluating the safety and immunogenicity of GEO-CM04S1, compared to either the Pfizer/BioNTech or Moderna mRNA-based vaccine, in patients who have previously received either an allogeneic hematopoietic cell transplant, an autologous hematopoietic cell transplant or chimeric antigen receptor (CAR) T cell therapy (i.e., patients who have reduced immune system function as a result of treatment).

These patients have significantly compromised immune system function and generally respond at suboptimal levels after receiving currently available COVID-19 vaccines. As such, these patients are at greater risk for developing severe disease if infected and would likely benefit from the types of immune responses induced by the GEO-CM04S1 vaccine, which are more broadly specific and include activation of both the antibody and T cell arms of the immune system. 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.

GEO-CM04S1 encodes for both the spike and nucleocapsid 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.

In addition to the ongoing Phase 2 study in hematological cancer patients, GEO-CM04S1 is being evaluated in two other Phase 2 clinical trials: As a booster vaccine for healthy patients who have previously received the Pfizer or Moderna mRNA vaccine. GeoVax recently announced that this trial has met its targeted patient enrollment. 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.