GEO-CM04S1 Vaccine Description
The GeoVax Labs GEO-CM04S1 vaccine candidate is a synthetic, non-replicating modified vaccinia Ankara (MVA) vaccine vector, developed as a double recombinant vectored vaccine to stimulate potent humoral and cellular immune responses against both the spike (S) and nucleocapsid (N) proteins of the SARS-CoV-2 virus. Upon immunization, the vaccine vector infects cells at the local injection site, leading to the expression of the SARS-CoV-2 antigens visible to the immune system.
GEO-CM04S1 is based upon a novel GV-MVA-VLP platform that integrates our recombinant Modified Vaccinia Ankara (MVA) vector technology with advanced antigen design and state-of-the-art manufacturing technologies. On this platform, MVA, a large virus capable of carrying several vaccine antigens, expresses proteins that assemble into VLP immunogens within (in vivo) the person receiving the vaccine. Vaccines produced on this platform are safe, highly immunogenic, suitable for repeated use, stable at refrigerator temperatures, lyophilized, and amenable to rapid and affordable scale-up for use in both epidemic response and routine vaccination.
The production of VLPs (Virus-Like Particles) in the vaccinated person mimics virus production in a natural infection, stimulating both the humoral and cellular arms of the immune system to recognize, prevent, and control the target infection. In addition, GEO-CM04S1 targeting of both S and N antigens may offer greater protection and durability against the significant sequence variation observed with the S antigen among variants of concern, such as Omicron.
The MVA-VLP derived vaccines elicit durable immune responses in the host similar to a live-attenuated virus while providing the safety characteristics of a replication-defective vector.
GeoVax Labs, Inc. is a clinical-stage biotechnology company located in Atlanta, GA, developing human vaccines and immunotherapies against infectious diseases and cancer using novel proprietary platforms.
GEO-CM04S1 Vaccine Indication
GEO-CM04S1 is a vaccine candidate that will be indicated to prevent COVID-19 disease in humans and is the only COVID-19 vaccine that includes both SARS-CoV-2 spike and nucleocapsid proteins to advance to a Phase 2 trial in cancer patients.
GEO-CM04S1 Vaccine Updates
March 22, 2022 - GeoVax Labs, Inc. announced that the U.S. Patent and Trademark Office has issued Patent No. 11278607 to GeoVax, pursuant to the Company’s patent application No. 16/068,527 entitled “Compositions and Methods for Generating an Immune Response to a Tumor-Associated Antigen.”
March 14, 2022 - GeoVax Labs, Inc. announced the engagement of CATO SMS to manage GeoVax’s two ongoing Phase 2 clinical trials of its vaccine candidate, GEO-CM04S1, against SARS-CoV-2.
Mar. 10, 2022 - A COVID-19 investigational vaccine, developed by City of Hope scientists and now licensed to GeoVax Labs Inc., produced a robust neutralizing antibody and T cell (an immune cell) response against SARS-CoV-2 with no significant side effects in Phase 1 clinical trial, according to a study published in The Lancet Microbe.
March 18, 2020 - GeoVax's Chief Scientific Officer, Farshad Guirakhoo, Ph.D., stated, “We are pleased with our three vaccine candidates' rapid progress with design, construction, and in vitro characterizations. From here, we will narrow to one vaccine candidate based on the safety, immunogenicity and protective efficacy of our PreMaster Seed Viruses observed in upcoming animal studies. The final candidate will proceed directly to manufacturing and initial human clinical testing for safety and immunogenicity.”
March 4, 2020 - GeoVax uses its GV-MVA-VLPTM vaccine platform and expertise to design and construct vaccine candidates using genetic sequences from the virus responsible for the COVID-19 outbreak in Wuhan, China. In late January, the Company entered into a letter of intent to collaborate with BravoVax, a vaccine developer in Wuhan, China, to jointly develop a vaccine. Under the arrangement, upon receipt of vaccine candidates from GeoVax, BravoVax will provide testing and manufacturing support and direct interactions with Chinese public health and regulatory authorities. Dr. Guirakhoo stated, “Development of a safe and effective vaccine to stem current and future epidemics of COVID-19 is a high priority for us. We have designed several vaccine candidates, which will be narrowed through appropriate animal testing studies based on their safety, immunogenicity and protective efficacy. The final candidate will then be selected for manufacturing and initial human clinical testing for safety and immunogenicity. Our preliminary work with BravoVax is proceeding productively, with ongoing cross-contributions to the testing plans and respective dialogue with funding agencies.
January 27, 2020 - GeoVax Labs, Inc. and BravoVax, a vaccine developer in Wuhan, China, announced the signing of a Letter of Intent to jointly develop a vaccine against the new coronavirus. BravoVax will provide further development, including testing and manufacturing support and direct interactions with Chinese public health and regulatory authorities.
GEO-CM04S1 Vaccine Dosage
GEO-CM04S1 Vaccine Clinical Trials
GEO-CM04S1 is being studied in an ongoing Phase 2 clinical trial (NCT04977024) to evaluate its safety and immunogenicity, compared to the Pfizer/BioNTech mRNA-based vaccine, in patients who have previously received either an allogeneic hematopoietic cell transplant, an autologous hematopoietic cell transplant or chimeric antigen receptor (CAR) T cell therapy.
In December 2021, patient enrollment began for the Phase 2 portion of a Phase 1/2 trial (NCT04639466) of GEO-CM04S1, evaluating its use as a universal booster vaccine to current FDA-approved two-shot mRNA vaccines from Pfizer/BioNTech and Moderna.