The COVID-19 Angle — Targeting the Underserved
While the broader COVID-19 vaccine market is well-established, GeoVax is carving out a specific niche: immunocompromised patients. There are an estimated 23 million immunocompromised individuals in the U.S. and 250 million+ worldwide — a population for whom current mRNA vaccines often provide limited protection.
GeoVax's vaccine candidate, GEO-CM04S1, targets two key parts of the SARS-CoV-2 virus rather than just one, designed to generate a broader immune response than current vaccines.
Multiple Phase 2 clinical trials are underway:
✓ A trial evaluating GEO-CM04S1 as a primary vaccine for stem cell transplant patients, compared against Pfizer and Moderna vaccines, at the City of Hope Medical Center
✓ A booster trial for patients with chronic lymphocytic leukemia (CLL), a population with severely depleted immune systems
✓ A fully enrolled Phase 2 booster trial for healthy adults who previously received mRNA vaccines
The CLL trial has been welcomed by the CLL Society, adding advocacy support.
Oncology: Two Platforms, Multiple Targets
Beyond infectious diseases, GeoVax has expanded into oncology through its acquisition of Gedeptin — a novel cancer therapy designed to destroy tumor cells from the inside while limiting damage to surrounding healthy tissue. It is currently in clinical trials for advanced head and neck cancer.
Head and neck cancer is the 7th most common cancer worldwide, with approximately 70,000 new cases and 15,000 deaths annually in the U.S. Tumor recurrence develops in roughly one-third of patients, with five-year survival rates for recurrent cases ranging from just 25% to 40%.
Key developments for the Gedeptin program include:
✓ FDA Orphan Drug status granted for the direct treatment of accessible oral and throat cancers
✓ Phase 1/2 trial recently completed enrollment at Stanford University, Emory University, and Thomas Jefferson University
✓ Phase 1 data previously showed pronounced effect on tumor volume after a single treatment cycle
✓ FDA provided direct funding for the Phase 1/2 trial under its Orphan Products Clinical Trials Grants Program
✓ Discussions anticipated with FDA regarding an expanded Phase 2 program targeting an expedited registration pathway
Orphan Drug status provides significant regulatory advantages — reduced fees, faster review, and up to seven years of market exclusivity blocking competing therapies.
Additionally, preclinical work using the MVA platform to target cancer cells has shown encouraging results...
In one study, a GeoVax cancer vaccine combined with an immune checkpoint therapy resulted in a 57% reduction in tumor growth compared to untreated controls. In a tumor recurrence model, vaccination achieved 100% prevention of tumor growth versus 100% growth in untreated controls.
