GeoVax Labs, Inc. announced that it has commenced the planned site expansion for the Phase 2 clinical trial investigating its next-generation SARS-CoV-2 vaccine, GEO-CM04S1, as a primary vaccine in immunocompromised patients. In addition to study enrollments completed at the City of Hope Medical Center (Duarte, California), the trial will be initiating enrollment of eligible patients at Wake Forest Baptist Medical Center (Winston Salem, North Carolina), the University of Massachusetts Medical Center (Worcester, Massachusetts), and Fred Hutchinson Cancer Research Center (Seattle, Washington). The Phase 2 clinical trial (ClinicalTrials.gov Identifier: NCT04977024) is evaluating the safety and immunogenicity of GEO-CM04S 1, compared to either the Pfizer/BioNTech or Moderna mRNA-based vaccine, in patients with hematologic malignancies who have received either an allogeneic hematopoietic stem cell transplant, an autologous hematopoieticstem cell transplant or chimeric antigen receptor (CAR) T cell therapy.

Such patients often have difficulty mounting an adequate protective antibody response after receiving currently available COVID-19 vaccines. The unique properties of GEO- CM04S1 potentially offer a more robust, durable degree of protection than the current authorized COVID-19 vaccines, not only as a vaccine for highly vulnerable immunocompromised patients for whom the currently authorized mRNA vaccines may be inadequate, but also potentially for healthy patients as a universal booster vaccine to the mRNA vaccines. In the U.S., there are approximately 15 million individuals who, as a result of their compromised immune systems, often do not adequately respond to the current authorized mRNA vaccines.

These data support the progression of the Phase 2 clinical study, which includes a direct comparison to currently approved mRNA vaccines. Vaccines of this format should not require frequent and repeated modification or updating. In addition to this ongoing study, GEO-CM04 S1 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.