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GeoVax Receives BARDA Project NextGen Award to Conduct Phase 2b Clinical Study Evaluating the Company's Next-Generation COVID-19 Vaccine Candidate, GEO-CM04S1
10,000-participant randomized Phase 2b study will evaluate and compare GeoVax's multi-antigen, vaccine candidate (GEO-CM04S1) to an approved vaccine against
About this update from Geovax Labs, Inc.
[{"type":"text","content":" \n10,000-participant randomized Phase 2b study will evaluate and compare GeoVax's multi-antigen, vaccine candidate (GEO-CM04S1) to an approved vaccine against COVID-19 under BARDA's Clinical Studies Network\n\n\nProject NextGen is a $5 billion initiative by the U.S. Department of Health and Human Services to develop innovative vaccines and therapeutics providing broader and more durable protection against current and future COVID-19 viral strains\n \nATLANTA, GA - (NewMediaWire) - June 18, 2024 - GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that it received an award through the Rapid Response Partnership Vehicle (RRPV) to advance development of GEO-CM04S1, GeoVax's dual-antigen next-generation COVID-19 vaccine, in a Phase 2b clinical trial. The RRPV is a Consortium funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS).\n\nUnder the agreement, GeoVax will sponsor a 10,000-participant, randomized, Phase 2b double-blinded study to compare the efficacy, safety, and immunogenicity of GEO-CM04S1 with a U.S. Food and Drug Administration (FDA)-approved mRNA COVID-19 vaccine. Preparations for the study are underway, and execution of the study will be fully funded by BARDA under its Clinical Studies Network.\n\nThe direct award to GeoVax of approximately $24.3 million, which may increase to as much as $45 million, will fund the manufacturing of clinical materials and support for the Phase 2b clinical trial, including regulatory activities. BARDA has made separate awards through its Clinical Studies Network to support execution of the study. That funding will represent approximately $343M from the Project NextGen program for a CRO to execute the clinical trial using GeoVax's vaccine.\n\n\"We are honored and proud to receive this award from BARDA to advance our next-generation vaccine against COVID-19. This contract not only provides the vital resources for advancing the development of GEO-CM04S1, but it also advances our MVA platform in infectious diseases,\" said David Dodd, Chairman & CEO of GeoVax.\n\nMr. Dodd continued, \"First-generation COVID-19 vaccines were beneficial d...