$GOVX .055 **MUST READ** Highlights for GeoVax Labs, Inc. (GOVX-OTC)GeoVax Labs, Inc. (“GeoVax” or the “Company”) is a clinical-stage biotechnology company creating human vaccines against infectious diseases and cancer using an innovative and patented Modified Vaccinia Ankara Virus Like Particle (MVA-VLP) platform technology. This technology supports production of non-infectious virus-like particles (VLPs) from the cells of the individual receiving the vaccine. The Company is currently focused on developing vaccines against human immunodeficiency virus (HIV), Zika virus (ZIKV), hemorrhagic fever (HF) viruses (Ebola, Sudan, Marburg, and Lassa), and malaria. The Company also has programs to develop a vaccine to treat chronic Hepatitis B virus (HBV) infection and to apply its MVA-VLP technology to cancer immunotherapy (immuno-oncology). GeoVax employs Modified Vaccinia Ankara (MVA) as a vector to express foreign antigens on VLPs generated in vivo within vaccinated patients. Its MVA-VLP is the fourth generation MVA vector, licensed from the National Institutes of Health (NIH), which is modified for insertion sites for high expression and transgene stability during manufacture. This platform has shown to be suitable for vaccination against a range of disease agents. The Company has multiple license and research collaboration agreements to advance its product candidates, including: (1) a Cooperative Research and Development Agreement (CRADA) with the NIH for MVAs used in the development of HF, Zika, HBV, malaria, and immuno-oncology vaccines; (2) a collaboration with the U.S. Centers for Disease Control and Prevention (CDC) for the development of a Zika vaccine; (3) a collaboration agreement with Georgia State University (GSU) for the advancement of the Company’s HBV therapeutic program; (4) a collaboration agreement with the Burnet Institute in Australia (www.burnet.edu.au) for the development of a malaria vaccine; (5) a research collaboration agreement with the University of Pittsburgh for the development of the Company’s immuno-oncology program; and (6) exclusive license from Emory University for HIV vaccines. Importantly, by working with collaborators on multiple vaccine candidates, GeoVax is able to manage risk by providing multiple paths on the road to selecting the best vaccine candidate.
HIV/AIDS Vaccine Program
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. The preventive clade B HIV vaccine has successfully completed Phase 2a human clinical testing and in January 2017, GeoVax began the next human clinical trial (HVTN 114) on the path toward human efficacy trials. HVTN 114 is testing the ability of “late boosts” to increase the antibody responses elicited by GOVX-B11. These “late boosts” consist of the GeoVax MVA62B vaccine with or without a gp120 protein vaccine. HVTN 114 is being conducted by the HIV Vaccine Trials Network (HVTN)—the world’s largest publicly-funded international collaboration focused on developing vaccines to prevent HIV/AIDS (www.hvtn.org). with funding from the National Institute of Allergy and Infectious Diseases (NIAID). Information from this trial is expected to contribute to the design of future human clinical trials testing GOVX-B11 in the presence and absence of newer gp120 proteins, which are currently being cGMP (Current Good Manufacturing Practice) manufactured. During 2016, NIAID awarded GeoVax a Staged Vaccine Development contract of up to $7.8 million for production of the DNA vaccine component of GOVX-B11 in sufficient quantities for use in advanced clinical trials. Within the HIV category (in existence for roughly 35 years), there are no approved vaccines. GeoVax continues to move down the clinical pathway. The next goal is to reach an efficacy trial, which would be a Phase 2b trial (involving thousands of individuals). Current antiretroviral therapies (ARTs) do not eliminate HIV infection, where infected individuals must remain
HIV/AIDS Vaccine Program
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. The preventive clade B HIV vaccine has successfully completed Phase 2a human clinical testing and in January 2017, GeoVax began the next human clinical trial (HVTN 114) on the path toward human efficacy trials. HVTN 114 is testing the ability of “late boosts” to increase the antibody responses elicited by GOVX-B11. These “late boosts” consist of the GeoVax MVA62B vaccine with or without a gp120 protein vaccine. HVTN 114 is being conducted by the HIV Vaccine Trials Network (HVTN)—the world’s largest publicly-funded international collaboration focused on developing vaccines to prevent HIV/AIDS (www.hvtn.org). with funding from the National Institute of Allergy and Infectious Diseases (NIAID). Information from this trial is expected to contribute to the design of future human clinical trials testing GOVX-B11 in the presence and absence of newer gp120 proteins, which are currently being cGMP (Current Good Manufacturing Practice) manufactured. During 2016, NIAID awarded GeoVax a Staged Vaccine Development contract of up to $7.8 million for production of the DNA vaccine component of GOVX-B11 in sufficient quantities for use in advanced clinical trials. Within the HIV category (in existence for roughly 35 years), there are no approved vaccines. GeoVax continues to move down the clinical pathway. The next goal is to reach an efficacy trial, which would be a Phase 2b trial (involving thousands of individuals). Current antiretroviral therapies (ARTs) do not eliminate HIV infection, where infected individuals must remain
