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GeoVax Labs (OTCQB: GOVX) provided an update on where it currently stands with the development of all their human vaccines.
GeoVax Labs (OTCQB: GOVX) provided an update on where it currently stands with the development of all their human vaccines.
As quoted in the press release:
Robert T. McNally, PhD, GeoVax’s President & CEO, commented, “We have made great strides in our corporate development over the past year both in terms of advancing our ongoing programs and beginning new initiatives in some exciting areas. I am pleased to provide this update on our recent progress.”
HIV (Preventive Vaccine) – Our 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. In January 2017, we 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) with funding from the National Institute of Allergy and Infectious Diseases (NIAID). Information from this trial will 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 manufactured. During 2016, NIAID also 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.
HIV (Therapeutic Vaccine) – In March 2017, we began a collaboration with American Gene Technologies International, Inc. (AGT) in which AGT plans to commence a Phase 1 human clinical trial testing our combined technologies for the development of a functional cure for HIV infection. In an earlier Phase 1 clinical trial of our MVA-VLP HIV vaccine, we observed the ability of our vaccine to stimulate production of CD4+ T cells in HIV-positive individuals — the intended use of our vaccine in the AGT study. The GeoVax vaccine will be used to stimulate virus-specific CD4+ T cells in vivo, which will then be harvested from the patient, genetically modified using AGT’s proprietary lentiviral vector technology, and reinfused into the patient. The primary objectives of the trial, which is targeted to start in 2017, are to assess the safety and efficacy of the combined therapy, with secondary objectives to assess the immune responses and levels of virus reservoirs as measures of efficacy.
Zika Virus – A research collaboration with the Centers for Disease Control and Prevention (CDC) for development of our preventive vaccine against Zika virus (ZIKV) is ongoing. A highly rigorous preclinical challenge model has been developed and has demonstrated impressive results for our GEO-ZM02 vaccine, protecting 100% of mice infected with a lethal dose of ZIKV delivered directly to the brain. GEO-ZM02 not only has the potential to be a single-dose vaccine, which is practical to combat epidemics in resource strained countries, but also does not bear the risk of enhancing other flavivirus infections, such as Dengue virus, in vaccinated subjects. This phenomenon, called Antibody Dependent Enhancement (ADE), has been the topic of recent publications, and is a safety concern for other Zika vaccines under development, all of which utilize the structural Envelope (E) protein of ZIKV in their vaccine constructs. Our vaccine is based on the non-structural-1 (NS1) protein of ZIKV, which is not involved in ADE. Moreover, the NS1 protein is abundantly secreted into the blood of ZIKV infected individuals and plays a critical role in flavivirus acquisition by mosquitoes by overcoming the immune barrier of the mosquito midgut. Therefore, GEO-ZM02 should not only safely protect populations against ZIKV infections but could also block further transmission of ZIKV from humans to its mosquito vector.