ATLANTA, GA--(Marketwired - Oct 20, 2016) - GeoVax Labs, Inc. (OTCQB: GOVX), a biotechnology company specializing in developing human vaccines, announced today the presentation of clinical data from a phase 1 human clinical trial of its investigational HIV vaccine (trial designation HVTN 094) at the HIV Research for Prevention, Partnering for Prevention (HIVR4P) conference in Chicago, Illinois.
The presentation, entitled "DNA/MVA HIV Vaccine Producing Virus-like Particles (VLPs) is Well-tolerated and Induces Durable Functional Antibodies (Abs) in HVTN 094", was delivered by Susan P. Buchbinder, MD, Director of Bridge HIV at the San Francisco Department of Public Health.
HVTN 094 evaluated the safety and immunogenicity of GeoVax's adjuvanted DNA/MVA vaccine that co-expresses GM-CSF in the priming DNA vaccine. Four U.S. clinical sites randomized a total of 48 participants to receive one of three vaccine dosing regimens.
All vaccination regimens were well-tolerated and safe. Conclusions drawn from the study were that the DNA/MVA prime-boost regimen induced functional humoral responses that included antibody dependent cellular cytotoxicity (ADCC), antibody avidity, and Env IgG1 and IgG3 binding responses with specificities in the gp41 subunit of Env known to mediate virus capture and phagocytosis (an immune system process that removes pathogens). A third MVA boost was shown to enhance both the titers and function of the antibody responses. Because the levels of antibody primed by the DNA vaccine, with or without the co-expression of GM-CSF, were similar, the DNA product without co-expressed GM-CSF will be used in further clinical trials. Also, based on the third MVA boost enhancing immune responses, further trials will include a third MVA boost. HVTN 094 was conducted by the HIV Vaccine Trials Network (HVTN) with funding support from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
Harriet L. Robinson, PhD, GeoVax's Chief Scientific Officer, commented, "We are pleased with the outcome of the HVTN 094 trial, which added to the prior clinical data demonstrating the excellent safety profile of our vaccine. Also, in HVTN 094, the regimen using two full dose DNA primes followed by three MVA boosts elicited remarkably durable IgG1 and IgG3 responses to gp41. At six months post-vaccination, essentially all participants had detectable IgG1 responses and approximately 40% of the participants had detectable IgG3 responses. Response rates and magnitudes dropped only slightly from six to twelve months post-vaccination. We wish to thank the extensive team at HVTN involved with the conduct and evaluation of this study. We also want to thank NIAID for their support of HVTN 094, and for their continued support of our HIV vaccine program."
Dr. Robinson continued, "We now look forward to the commencement of the HVTN 114 trial, which will begin the evaluation of our vaccine in combination with a protein boost. HVTN 114 is scheduled to start in December of this year."
The HVTN is the largest worldwide clinical trials network dedicated to the development and testing of preventive HIV/AIDS vaccines. The HVTN is an international collaboration that conducts all phases of clinical trials, from evaluating experimental vaccines for safety and the ability to stimulate immune responses, to testing vaccine efficacy. Support for the HVTN comes from NIAID. The Network's HIV Vaccine Trial Units are located at leading research institutions in 27 cities on four continents. The Network's headquarters are at the Fred Hutchinson Cancer Research Center in Seattle, Washington. For more information, go to www.hvtn.org.
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 vaccines against HIV, Zika Virus, and hemorrhagic fever viruses (Ebola, Sudan, Marburg, and Lassa). GeoVax also recently began programs to evaluate the use of its MVA-VLP platform in cancer immunotherapy, and for therapeutic use in chronic Hepatitis B infections. GeoVax's vaccine platform supports in vivo production of non-infectious VLPs from the cells of the very person receiving the vaccine, mimicking 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.