Analysis of Open-Label Portion of Ongoing Phase 2 Trial of GEO-CM04S1 Presented at 23rd Annual World Vaccine Congress
Atlanta, GA, April 6, 2023 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, presented an update on the development of its SARS-CoV-2 vaccine, GEO-CM04S1, including preliminary data from an ongoing Phase 2 clinical trial, during the 23rd Annual World Vaccine Congress taking place in Washington, DC.
The presentation, titled “COVID-19 Vaccine CM04S1; A Superior Viral Platform Alternative for Eliciting Durable T Cell Responses in Immunocompromised Hematologic Malignancy Patients,” was delivered by Dr. Don Diamond, Department of Hematology & Hematopoietic Cell Transplantation, City of Hope.
CM04S1 is a next-generation COVID-19 vaccine based on GeoVax’s MVA viral vector platform, which supports the presentation of multiple vaccine antigens to the immune system in a single dose. CM04S1 presents both the spike and nucleocapsid antigens of SARS-CoV-2 and is specifically designed to induce both antibody and T cell responses to non-variable parts of the virus. The more broadly specific and functional engagement of the immune system is designed to provide protection against the new and continually emerging variants of COVID-19. Based on data from animal models and a completed Phase 1 clinical study, vaccine-induced immune responses were shown to recognize both early and later variants of SARS-CoV-2, including the Omicron variant. Vaccines of this format should not require repeated modification and updating.
Dr. Diamond’s presentation included unpublished data from the open-label portion of the Phase 2 trial of CM04S1 (ClinicalTrials.gov Identifier: NCT04977024) in patients undergoing hematological cancer treatment (i.e., patients who have reduced immune system function as a result of treatment). The preliminary analysis indicates CM04S1 is highly immunogenic in these patients, inducing both antibody responses, including neutralizing antibodies, and T cell responses. These data support the planned progression of the Phase 2 clinical study, which will include a direct comparison to currently approved mRNA vaccines.
CM04S1 continues to advance in a second Phase 2 clinical trial as a booster for healthy patients who have previously received the Pfizer or Moderna mRNA vaccine (ClinicalTrials.gov Identifier: NCT04639466). Data from these studies will form the basis for comparing vaccine potential in unique patient groups as well as the general population.
David Dodd, GeoVax’s Chairman and CEO, commented, “We are delighted with the continued encouraging results of our COVID-19 vaccine, especially related to addressing the critical needs of the high-risk immunocompromised patient populations. GeoVax is focusing on the clinical development of this vaccine for use in patients with special medical limitations or needs, specifically the immunocompromised populations. These individuals may be unable to raise or maintain protective antibody responses after receipt of first-generation mRNA vaccines, contributing to reduced vaccine efficacy. This includes patients suffering from and/or being treated for numerous malignancies and autoimmune disorders, transplant patients, dialysis patients, and potentially the aging population.”
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in two Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a COVID-19 vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient. In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, visit our website: www.geovax.com.
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