GeoVax Labs, Inc. (NASDAQ: GOVX) is making strides in its clinical development programs, particularly with Gedeptin, a therapy for advanced head and neck cancer, and GEO-CM04S1, its next-generation COVID-19 vaccine. These advancements were highlighted during the company's Q3 2023 corporate update call, alongside a review of its financial status.
Gedeptin for Head and Neck Cancer
Gedeptin is based on a gene therapy strategy known as Gene-Directed Enzyme Prodrug Therapy (GDEPT). This approach uses a vector to selectively transduce tumor cells with a non-human gene, which then expresses an enzyme that can convert a non-toxic prodrug into a highly toxic anti-tumor compound directly within the tumor. The therapy is tumor-agnostic, offering potential application across various solid tumors.
"Our initial targeted patient population for the application of GDEPTN represents those who are in stage care... These patients represent a critical unmet medical need," stated David Dodd, Chairman and CEO of GeoVax. He noted that many of these patients have exhausted existing therapies and are primarily receiving palliative care. The goal is to improve their end-stage quality of life by reducing or eliminating targeted tumors.
The current protocol involves up to five treatment cycles, each with intratumoral injections of Gedeptin followed by infusions of fludarabine phosphate. Initial data from the ongoing multi-site trial, presented at the AACR-AHNS International Conference in Montreal, indicated that Gedeptin administration was safe and feasible. The company anticipates completing the initial trial by the end of Q1 2024 and plans to discuss an expanded Phase 2 trial with the FDA.
GEO-CM04S1: Next-Generation COVID-19 Vaccine
GEO-CM04S1 is designed to stimulate both antibody and cellular immune responses, potentially providing more robust and durable protection compared to current COVID-19 vaccines. This is particularly important for immunocompromised individuals, who often do not respond adequately to existing vaccines and monoclonal antibody therapies.
"There's a major critical need for next generation COVID-19 vaccines to support such individuals, and we believe that CMO4S1 is the leading next generation vaccine currently in clinical development," Dodd explained. He also mentioned active discussions regarding participation in Project NextGen, a $5 billion initiative to develop COVID-19 vaccines with enhanced protection against variants.
Financial Status
Mark Reynolds, CFO of GeoVax, reported that research and development expenses increased to $6.9 million and $14.5 million for the three-month and nine-month periods in 2023, respectively, primarily due to clinical trial activities for CMO4S1 and Gedeptin. The company's cash balances at September 30, 2023, were approximately $12.7 million. GeoVax expects to raise additional capital in 2024 to fund its ongoing Phase 2 clinical programs.
Strategic Outlook
GeoVax is focused on advancing its clinical programs and exploring partnerships for worldwide commercialization. The company's strategy is centered around innovation, differentiation, acceleration, and collaboration, with a focus on addressing unmet medical needs and achieving leadership in targeted patient populations.
