Crystal Research Associates has issued a 16-page Quarterly Update on clinical-stage biotechnology company, GeoVax, Labs Inc. (GOVX-OTC), detailing the Company's recent news and developments, anticipated clinical trial and regulatory filing milestones, and financial position. The report is available for download below.
Snapshot of GeoVax
GeoVax Labs, Inc. (“GeoVax” or “the Company”) is a uniquely-positioned clinical-stage biotechnology company developing preventative and therapeutic human vaccines against infectious diseases and cancer. The Company’s patented Modified Vaccinia Ankara Virus-Like Particle (MVA-VLP) technology is the foundation for producing non-infectious virus-like particles (VLPs) from the cells of the individual receiving the vaccine. Producing VLPs in a vaccinated individual mimics a natural infection, stimulating both the humoral and cellular arms of the immune system to recognize, prevent, and control the target infection should it appear, while maintaining the safety characteristics of a replication-defective vector. GeoVax is 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 believes its expertise is complementary to a range of other human diseases for which there is an unmet medical need, and consequently, has plans to expand its pipeline
Key Points of GeoVax's Business
- GeoVax’s most advanced vaccine in the clinic, GOVX-B11, is designed to protect against the clade B subtype of the HIV virus (prevalent in the Americas, Western Europe, Japan, and Australia). This vaccine has demonstrated safety and highly reproducible immunogenicity; has successfully completed Phase 2a human clinical testing; and has entered a follow-on clinical trial with financial and operational support from the National Institutes of Health (NIH). The next planned clinical trial of GOVX-B11 is expected to be an additional Phase 1 trial, evaluating the safety and immunogenicity of a prime-boost regimen of GOVX-B11 with and without two additional protein boosts. This trial is to be conducted by HVTN with funding from NIAID, with an anticipated start date of mid-2018.
- The Company’s HIV vaccine technology was developed in collaboration with researchers at Emory University, the NIH, and the Centers for Disease Control and Prevention (CDC). The technology is exclusively licensed to GeoVax from Emory. GeoVax also has nonexclusive licenses to certain patents owned by the NIH used to develop the Company’s other vaccines.
- GeoVax’s novel preclinical Zika vaccine (GEO-ZM02) is designed to avoid safety concerns shown with other Zika vaccines in development. During the quarter, the Company presented data at multiple conferences showing that a single dose of GEO-ZM02 gave 100% protection in mice challenged with a lethal dose of Zika virus (ZIKV) delivered directly into the brain.
- The Company’s vaccine development activities are financially supported by the U.S. Government in the form of research grants, in-kind support in terms of animal experiments, and indirect support for human clinical trials. GeoVax’s HIV program receives substantial federal support (having received >$50 million to date from the NIH).
- GeoVax remains focused on transitioning its technologies into Phase 1 clinical trials for three vaccines targets—Zika, Lassa Fever, and its immunooncology program. The Company has promising preclinical data and is focused on fund raising to bring about the next stage of development. By means of working with multiple collaborators on a variety of vaccine candidates, GeoVax is able to manage development risk by creating many paths on the road to selecting the best vaccine candidate.
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