GeoVax is developing several therapies focused on addressing unmet medical needs. Current active clinical trials are outlined below:

GEO-CM04S1 

GeoVax’s infectious disease development pipeline includes programs targeting Coronavirus, including a Covid-19 vaccine for immunocompromised patients, a Covid-19 vaccine for patients with chronic lymphocytic leukemia, and a Covid vaccine booster for healthy volunteers. We continue to focus on Covid-19 vaccine development because there are significant limitations to the first-generation vaccines that were deployed during the emergency authorization period in 2020 and 2021.

GEO-CM04S1 is our next-generation Covid-19 vaccine designed to increase the magnitude, duration, and functional breadth of the immune response, including the establishment of long-term immunological memory to achieve a higher level of protection. This issue is a particular area of concern for elderly patients or patients who are immunocompromised because they cannot mount nor maintain a high enough level of a protective response to the first-generation mRNA vaccines to convey long-term protection. There are an estimated 23 million immunocompromised patients in the U.S., and 250 million+ worldwide.

Phase 2 – Covid-19 Vaccine for Immunocompromised/Stem Cell Transplant Patients

A double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of GEO-CM04S1 as a primary vaccine for immunocompromised stem cell transplant patients. This study is investigating GEO-CM04S1 compared to either the Pfizer-BioNTech or Moderna mRNA-based vaccine, with the primary goal of showing increased immune response and subsequent protection from Covid-19 in patients with blood cancer who have received stem cell transplant or cellular therapy. The study is being conducted at the City of Hope Medical Center, Duarte, CA.

For more information, visit ClinicalTrials.gov ID: NCT04977024

Phase 2 Trial – Covid-19 Vaccine Booster Immunocompromised/Chronic Lymphocytic Leukemia Patients

The study is comparing the effect of the GEO-CM04S1 vaccine with the current standard of care vaccine in preventing Covid-19 infections in patients with chronic lymphocytic leukemia (CLL). The study is being conducted at the City of Hope Medical Center, Duarte, CA.

For more information, visit ClinicalTrials.gov ID: NCT05672355

Phase 2 – Covid-19 Booster Vaccine for Healthy Adult Patients (Fully Enrolled)

GeoVax is investigating GEO-CM04S1 in a Phase 2 trial as a booster for healthy adult patients who have previously received either the Pfizer-BioNTech or Moderna vaccine as their initial inoculation. The goal is to show a superior immune response and subsequent protection. The immunological responses measured throughout the study will include both the level of SARS-CoV-2 neutralizing antibodies and specific T-cell responses. This study is closed to further new patient enrollment.

For more information, visit ClinicalTrials.gov ID: NCT04639466

Gedeptin

Gedeptin is a gene-directed enzyme prodrug therapy (GDEPT) that results in the formation of the oncolytic agent within the tumor itself, resulting in tumor cell death while significantly limiting systemic exposure. Preclinical and early-stage human clinical data suggest the GDEPT approach can destroy otherwise refractory cancer cells in a safe and effective manner.

Gedeptin has been awarded U.S. FDA Orphan Drug status for the intratumoral treatment of anatomically accessible oral and pharyngeal cancers, including cancers of the lip, tongue, gum, floor of the mouth, salivary gland, and other oral cavities. The orphan drug designation is awarded to drugs designed to treat a rare disease or condition that affects fewer than 200,000 people in the U.S.

Phase 1/2 Trial – Head and Neck Cancer (Fully Enrolled)

Open-label Study Evaluating Safety of Repeat Administration of Ad/PNP-F-araAMP (Ad/PNP Administered Intratumorally Followed by Intravenous Fludarabine Phosphate) in Subjects With Recurrent, Local Head and Neck Cancer conducted at Stanford University, Emory University, and Thomas Jefferson University.

For more information, visit ClinicalTrials.gov ID: NCT03754933