GeoVax Reports Progress on COVID-19 Vaccine and Cancer Therapies in Q3 2024 Update

GeoVax Labs, Inc., a biotechnology company developing immunotherapies and vaccines, has reported significant progress across its pipeline in its third quarter 2024 financial results and business update. The company is advancing multiple clinical programs, with a focus on its COVID-19 vaccine candidate GEO-CM04S1 and cancer therapy Gedeptin.

A key development is the preparation for a 10,000-participant Phase 2b clinical study of GEO-CM04S1 as part of the BARDA Project NextGen program, supported by a nearly $400 million award. This large-scale trial aims to compare GEO-CM04S1's efficacy, safety, and immunogenicity against an FDA-approved mRNA COVID-19 vaccine. The study's initiation represents a critical step in developing potentially more effective COVID-19 vaccines.

GeoVax also anticipates reporting interim results from two ongoing Phase 2 trials of GEO-CM04S1 in the fourth quarter of 2024. These trials are evaluating the vaccine in immunocompromised patients with chronic lymphocytic leukemia and as a booster in healthy adults, potentially addressing unmet needs in COVID-19 vaccination strategies.

In oncology, GeoVax is preparing to advance Gedeptin, its gene therapy for head and neck cancers, into a Phase 2 trial. The study, expected to begin in the first half of 2025, will evaluate Gedeptin in combination with an immune checkpoint inhibitor for first recurrent head and neck cancer. This approach could offer new treatment options for patients with difficult-to-treat solid tumors.

The company is also making strides in its Mpox vaccine program, with GEO-MVA expected to complete cGMP clinical batch production in Q4 2024. This development is significant as it aims to create the first U.S.-based source for an Mpox vaccine, addressing an important biodefense goal.

Financially, GeoVax reported a net loss of $5.8 million for Q3 2024, compared to $8.4 million in the same period of 2023. The company's cash position stood at $8.6 million as of September 30, 2024, an improvement from $6.5 million at the end of 2023. The financial results reflect ongoing investments in research and development, balanced with revenue from government contracts.

These developments underscore GeoVax's commitment to advancing innovative treatments in infectious diseases and cancer. The progress in multiple clinical programs, particularly the large-scale COVID-19 vaccine trial and the advancement of cancer therapies, positions GeoVax as a significant player in addressing critical healthcare needs. The potential impact of these programs extends beyond individual patient care to broader public health and biodefense considerations, especially in light of the ongoing global focus on pandemic preparedness and cancer treatment advancements.