Investment Highlights for GeoVax Labs, Inc.(GOVX-OTC)
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing preventive and therapeutic vaccines against infectious diseases and cancer. The Company’s proprietary GV-MVA-VLP™ vector vaccine technology utilizes a Modified Vaccinia Ankara (MVA) vector, a large virus capable of carrying several vaccine antigens, that expresses non-infectious virus-like particles (VLPs) in the individual receiving the vaccine (in vivo). VLPs mimic a natural infection, stimulating the immune system to recognize, prevent, and control the target infection through durable immune responses.
The Company’s platform results in highly immunogenic, long-lasting, and safe vaccines. Important attributes of GeoVax’s vaccine platform include: the need for only a single dose with no adjuvant, durable immunity, and cost-effective manufacturing that is conducive to affordable scale-up. GeoVax’s HIV vaccines have demonstrated outstanding safety in multiple human clinical trials.
GeoVax is capitalizing on the safety and efficacy of its technology platform to address the urgent need for a COVID-19 vaccine and is also developing vaccines against human immunodeficiency virus (HIV), hemorrhagic fever (HF) viruses (Ebola, Sudan, Marburg, and Lassa), Zika virus (ZIKV), and malaria. Furthermore, GeoVax is applying its MVA-VLP technology to cancer immunotherapy (immuno-oncology).
The Company’s vaccine development activities are financially supported by the U.S. Government in the form of research grants and clinical trial support, with the Company’s HIV program having received >$50 million to date from the NIH. In addition, GeoVax has multiple license and research collaboration agreements to advance its product candidates. The Company’s owned and in-licensed worldwide patent estate includes 56 granted or pending patent applications spread over 16 patent families.
HIV/AIDS Vaccine Program
GeoVax’s HIV vaccine technology was developed in collaboration with researchers at Emory University, the National Institutes of Health (NIH), and the Centers for Disease Control and Prevention (CDC). The technology is exclusively licensed to GeoVax from Emory.
The Company’s most advanced program is a preventive vaccine (GOVX-B11) for the clade B subtype of HIV, the most common form of HIV in the Americas, Western and Central Europe, Australia, and Japan. GOVX-B11 has successfully completed Phase 1 and Phase 2a human clinical trials, in which GeoVax demonstrated that its VLPs, expressed in the cells of the person being vaccinated, are safe, yet elicit both strong and durable humoral and cellular immune response.
GeoVax began a follow-up human clinical trial (HVTN 132) testing the ability of “late boosts” (additional vaccinations given years after the original) to increase the antibody responses elicited by GOVX-B11. HVTN 132 is being conducted with support from the HVTN and funding from NIAID.
The Company has partnered with American Gene Technologies International Inc. (AGT) (March 2017) and the University of California, San Francisco (UCSF) (November 2019) to develop a functional cure for HIV infection. On August 24, 2020, GeoVax announced the initiation of the UCSF Phase 1 clinical study testing the companies’ combined technologies. The AGT trial has been cleared by the FDA and GeoVax expects its vaccine to be added to the trial in early 2021.
Hemorrhagic Fever (HF) Vaccine Program
GeoVax’s HF vaccine program is focused on developing a tetravalent vaccine (TV) designed to protect against all major HF viruses (Ebola, Sudan, Marburg, and Lassa) endemic in African countries. Each vaccine is also being developed as a monovalent GeoVax’s preclinical studies in rodents and non-human primates have demonstrated 100% single-dose protection in lethal challenge models for its EBOV, MARV, and LASV vaccines. Further development of this program is dependent upon additional funding support.
Zika Virus (ZIKV) Vaccine Program
GeoVax is focused on developing an MVA-Zika vaccine (GEO-ZM02). To date, the Company has demonstrated 100% protection of mice vaccinated with a single-dose of the Zika vaccine and exposed to a lethal dose of ZIKV. Further development of this program is dependent upon additional funding and/or partnering support.
Malaria Vaccine Program
GeoVax is collaborating with the Burnet Institute, a leading infectious disease research institute in Australia, as well as with Leidos, Inc. (under a contract from United States Agency for International Development [USAID] Malaria Vaccine Development Program) to develop a vaccine to prevent malaria infection and transmission by targeting antigens derived from multiple stages of the parasites’ life cycle. The Company’s vaccine constructs are currently being evaluated in small animal models.
Coronavirus Disease (COVID-19) Program
GeoVax has constructed four novel candidate vaccines and plans to use preclinical studies to select one in preparation for advancement to manufacturing and initial human clinical trials. The Company’s recent financing will allow it to aggressively pursue preclinical development activities as it awaits third-party funding for advanced development.
Cancer Immunotherapy Vaccine Program
GeoVax’s oncology programs include a cancer vaccine strategy for the treatment of solid tumors, combining MVA-VLP cancer vaccines (to stimulate an immune system response); immune check-point inhibitors (to reverse immune tumor tolerance); and select peptides.
The Company is collaborating with ViaMune, which has developed a fully synthetic MUC1 vaccine candidate (MTI), to assess each companies’ vaccine platform separately (and in combination) with the goal of developing a tumor Mucin 1 (MUC1) vaccine that can produce a broad spectrum of anti-tumor antibody and T cell responses. Preclinical studies of the combined MTI and MVA-VLP-MUC1 vaccines conducted at the University of North Carolina at Charlotte have shown the combination of the Company’s vaccine with MTI and ICI have significantly arrested tumor growth and shrank tumors in a mouse model for colorectal cancer. MUC1 protein is linked to a range of cancers, including breast, colon, ovarian, prostate, pancreatic, and lung.
In July 2018, GeoVax began collaborating with Emory University to develop a therapeutic vaccine for human papillomavirus (HPV) infection, with a specific focus on head and neck cancer (HNC). The GeoVax/Emory collaboration will include testing of GeoVax’s MVA-VLP-HPV vaccine candidates in therapeutic animal models of HPV. Furthermore, in November 2018, GeoVax announced a collaboration with Virometix, a company developing next-generation Synthetic Virus-Like Particle (SVLP™)-based vaccines, to develop a therapeutic vaccine for HPV infection using GeoVax’s MVA-vectored HPV vaccine candidates in combination with Virometix’ synthetic HPV vaccine candidate.