GeoVax Labs Inc
For the period ended May 1, 2025. Filed May 1, 2025.
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May 1, 2025 · Filed May 1, 2025
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Contents
EX-99.1 · Clinical Trial Progress and Operational Developments
Clinical Trial Progress and Operational Developments
GEO-CM04S1
| ● | GEO-CM04S1 continues to demonstrate potential as both a primary and booster vaccine, especially in immunocompromised patients. Key milestones anticipated during 2025 include: |
| o | Healthy Adult Booster Trial – Enrollment is complete, with data readout expected in the second quarter of 2025. |
| o | Chronic Lymphocytic Leukemia (CLL) Patient Study (Immunocompromised patient study) – Enrollment ongoing in Phase 2 study evaluating GEO-CM04S1 as a COVID-19 booster vaccine for immunocompromised patients; interim data resulted in continuation of the GEO-CM04S1 arm, whereas the Data Safety Review Board recommended early termination of the mRNA arm, which was subsequently implemented. |
| o | Stem Cell Transplant/CAR-T Trial (Immunocompromised patient study) – Enrollment and evaluation continue among hematological patients receiving stem cell transplantation or CAR-T therapy, comparing GEO-CM04S1 to mRNA COVID-19 vaccines. |
| ● | GEO-CM04S1 is a multi-antigen COVID-19 vaccine, utilizing a synthetic-MVA platform, expressing both S and N antigens, offering the potential for broader, more durable protection than current mRNA vaccines. |
| ● | Published peer-reviewed article in Vaccines (MDPI) - In April 2025, a peer-reviewed article titled “Preclinical Evaluation of a Multi-Antigen SARS-CoV-2 Vaccine Candidate GEO-CM02” was published in Vaccines (MDPI), which highlights the potential benefits of GeoVax’s multi-antigen COVID-19 vaccine approach and further validates the Company’s approach for developing GEO-CM04S1 utilizing the MVA platform. The publication supports the rationale for advancing next-generation COVID-19 vaccines capable of delivering broader, more durable immune responses. |
| ● | GEO-CMO4S1 addresses a significant medical need worldwide reflected in an estimated market potential at $30B+. |
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