ATLANTA, GA--(Marketwired - Mar 27, 2017) - GeoVax Labs, Inc. (OTCQB: GOVX), a biotechnology company developing human vaccines using its novel platform technology, today provided an update on its various development programs.
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.
Hemorrhagic Fever Viruses - Our hemorrhagic fever vaccine program is focused on developing a tetravalent vaccine designed to protect against all major hemorrhagic fever viruses (Ebola, Sudan, Marburg, Lassa) endemic in African countries. Each vaccine virus can also be developed as a monovalent vaccine. We have proven 100% protection in rodent and non-human primate challenge studies for our Ebola vaccine, and have demonstrated VLP production for each of the vaccines. The tetravalent vaccine currently is being tested in a rodent challenge study before progressing to non-human primates.
Immuno-Oncology - We are collaborating with ViaMune, Inc. for co-development of our respective cancer immunotherapy programs targeting an abnormal form of the autologous cell surface-associated protein, Mucin 1 (MUC1), which is overexpressed in metastatic cancers (e.g. breast, pancreatic, lung, and ovarian, cancers) and is often used as a diagnostic marker for cancer progression. The objective is to harness the patient's own immune system to fight their cancer. The initial proof-of-concept experiments are ongoing at the University of North Carolina at Chapel Hill in a mouse model evaluating tumor regression; data readouts and evaluation of this study is expected during the first half of 2017.
Chronic Hepatitis B - We initiated this program in mid-2016 to begin development of a therapeutic vaccine for chronic Hepatitis B (HBV) infections. During 2016 we completed much of design and construction of our vaccine candidates, and in January 2017 we entered into a collaboration with Georgia State University Research Foundation to advance our vaccine into preclinical testing, some of which will be conducted in an additional collaboration with the Shenzhen Graduate School of Peking University. Preclinical testing of two of our vaccine candidates has already started. Few effective treatment options for those infected with HBV exist and the need is great with 400 million global cases of chronic HBV.
Malaria - In January 2017, we announced the initiation of a new program to develop a vaccine to prevent malaria infection in collaboration with the Burnet Institute of Australia. The project will include the design, construction, and characterization of multiple malaria vaccine candidates using GeoVax's MVA-VLP vaccine platform combined with malaria Plasmodium falciparum and Plasmodium vivax sequences identified by the Burnet Institute. The vaccine design, construction, and characterization will be performed at GeoVax with further characterization and immunogenicity studies in mice and rabbits conducted at Burnet Institute using their unique functional assays that provide key information on vaccine efficacy. Malaria along with tuberculosis and HIV remain the top three global disease targets in severe need for preventive vaccines.
Other Corporate Developments - In December 2016, we announced the appointment of Farshad Guirakhoo, PhD, as our new Chief Scientific Officer to succeed Harriet Robinson, PhD, who remains as Chief Scientific Officer Emeritus and director of our HIV vaccine program. And in January 2017, we announced the formation of a Scientific Advisory Board composed of world-class scientists including Thomas Monath, MD; Stanley Plotkin, MD; Barney Graham, MD, PhD; Scott Weaver, PhD; and Olivera Finn, PhD.
GeoVax Labs, Inc., is a clinical-stage biotechnology company developing human vaccines against infectious diseases using its Modified Vaccinia Ankara-Virus-Like Particle (MVA-VLP) vaccine platform. The Company's development programs are focused on preventive vaccines against HIV, Zika Virus, hemorrhagic fever viruses (Ebola, Sudan, Marburg, Lassa) and malaria, as well as therapeutic vaccines for chronic Hepatitis B infections and cancers. GeoVax's vaccine platform supports in vivo production of non-infectious VLPs from the cells of the very person receiving the vaccine. The production of VLPs in the person being vaccinated 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. For more information, visit www.geovax.com.
Certain statements in this document are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act. These statements are based on management's current expectations and are subject to uncertainty and changes in circumstances. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax can develop and manufacture its vaccines with the desired characteristics in a timely manner, GeoVax's vaccines will be safe for human use, GeoVax's vaccines will effectively prevent targeted infections in humans, GeoVax's vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete vaccine development, there is development of competitive products that may be more effective or easier to use than GeoVax's products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements, and does not intend to do so. More information about these factors is contained in GeoVax's filings with the Securities and Exchange Commission including those set forth at "Risk Factors" in GeoVax's Form 10-K.