GeoVax discontinues COVID-19 vaccine to focus on mpox and cancer programs

GeoVax Labs Inc. (NASDAQ: GOVX) announced it will discontinue development of its GEO-CM04S1 COVID-19 vaccine candidate to concentrate resources on two lead programs, according to a company statement.

The clinical-stage biotechnology company said the decision to halt COVID-19 vaccine development was not due to safety concerns but reflects the contraction of the global COVID-19 vaccine market. The company will focus on GEO-MVA, a vaccine targeting mpox and smallpox, and Gedeptin, a cancer treatment.

GEO-MVA is advancing under an expedited regulatory pathway with European Medicines Agency scientific advice. The company said this approach enables potential approval based on a single pivotal immunobridging study demonstrating non-inferiority to an approved Modified Vaccinia Ankara vaccine.

The company has clinical-grade material manufactured for the planned Phase 3 immunobridging study. GeoVax said it has initiated outreach with global procurement stakeholders, including government agencies and biodefense programs, for potential vaccine supply agreements.

Gedeptin, the company's gene-directed enzyme prodrug therapy platform, will be evaluated in a planned Phase 2 study combining the treatment with pembrolizumab and fludarabine in a neoadjuvant setting for head and neck cancers.

"GeoVax is at an important inflection point, and this decision reflects a deliberate and disciplined focus on the programs we believe can deliver the greatest near-term and long-term value," said David Dodd, Chairman and Chief Executive Officer.

The company emphasized that portfolio prioritization is standard practice in biotechnology to align resources with market conditions and scientific developments.

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