GeoVax Labs Inc
Filed Sep 6, 2024.
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period unavailable · Filed Sep 6, 2024
Contents
Strategy
Our corporate strategy is to advance, protect and exploit our differentiated vaccine and oncology platforms leading to the successful development of preventive and therapeutic interventions against infectious diseases and various cancers. With our design and development capabilities, we are progressing and validating an array of cancer treatment and infectious disease vaccine product candidates. Our goal is to advance products through to human clinical testing, registration and commercialization in the U.S, and to seek partnership or licensing arrangements for achieving regulatory approval and commercialization outside of the U.S. We also leverage third party resources through collaborations and partnerships for preclinical and clinical testing with multiple government, academic and corporate entities.
Recent Development–** BARDA Project NextGen Award**–** GEO-CM04S1 Phase 2b Trial**
On June 18, 2024, we announced our receipt of an award through the Rapid Response Partnership Vehicle (RRPV) to advance development of GEO-CM04S1, our dual-antigen next-generation COVID-19 vaccine, in a Phase 2b clinical trial Under the agreement, GeoVax will sponsor a 10,000-participant, randomized, Phase 2b double-blinded study to assess the clinical efficacy, safety, and immunogenicity of GEO-CM04S1 compared with a U.S. Food and Drug Administration (FDA)-approved mRNA COVID-19 vaccine. 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).
Preparations for the Phase 2b study are underway, and execution of the study will be fully funded by BARDA under its Clinical Studies Network. The direct award to GeoVax of $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 a separate award of $343 million from the Project NextGen program to Allucent, a global clinical research organization (CRO), to execute the clinical trial as part of BARDA’s Clinical Studies Network. The combined value of the awards to GeoVax and Allucent toward the clinical evaluation of GEO-CM04S1 is expected to be $367-388 million
GEO-CM04S1–** Immunocompromised/Cell Transplant Phase 2 Trial**
| ● | GEO-CM04S1 is undergoing a Phase 2 multi-site clinical trial (ClinicalTrials.gov Identifier: NCT04977024), evaluating its safety and efficacy, compared to either the Pfizer/BioNTech or Moderna mRNA-based vaccine, as a preventive COVID-19 vaccine in high-risk immunocompromised patients (e.g. patients with blood cancers who have previously received either an allogeneic hematopoietic cell transplant, an autologous hematopoietic cell transplant or chimeric antigen receptor (CAR) T cell therapy). Data published from the open-label safety lead-in portion of the trial indicates that GEO-CM04S1 is highly immunogenic, inducing broad and durable neutralizing antibody and T cell responses. |
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GEO-CM04S1–** Healthy Adult Booster Phase 2 Trial**
| ● | A Phase 2 trial of GEO-CM04S1 (ClinicalTrials.gov Identifier: NCT04639466), evaluating two vaccine does levels as a heterologous COVID-19 booster vaccine to current FDA-approved mRNA vaccines from Pfizer/BioNTech and Moderna |
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| ● | In September 2023, we announced completion of enrollment. The trial protocol requires the subjects be followed for 12 months and the last data collection points are scheduled towards the end September 2024. Safety and immune response readouts from this study should be available towards the end of 2024 or early 2025. |
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| ● | In February 2024, we announced positive interim safety and immune responses findings following vaccine administration. Consolidated data (blinded to vaccine dose) from all subjects tested one-month post-vaccination, documented statistically significant increases in neutralizing antibody responses against multiple SARS-CoV-2 variants, ranging from the original Wuhan strain through Delta and Omicron XBB 1.5. |
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GEO-CM04S1–** Immunocompromised/CLL Trial Phase 2 Trial**
| ● | GEO-CM04S1 is undergoing an investigator-initiated Phase 2 clinical trial (ClinicalTrials.gov Identifier: NCT05672355), evaluating its use as a COVID-19 vaccine booster in patients with chronic lymphocytic leukemia (CLL), compared to the Pfizer/BioNTech mRNA-based vaccine. Interim data results are scheduled for Q3 2024. |
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