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GeoVax Provides Update on HIV Clinical Trials Program
Innovative Combination Vaccine Advancing in Clinical Trials
ATLANTA, GA, November 28, 2018 – GeoVax Labs, Inc. (OTCQB: GOVX), a biotechnology company developing human vaccines, today provided an update of the clinical development plan for its preventive vaccine (GOVX-B11) for clade B HIV. The HIV Vaccine Trials Network (HVTN) is moving forward with plans for a phase 1 trial, designated HVTN 132, which will be a multi-center, randomized, double-blind trial, enrolling up to 70 healthy adults. The primary objectives of the trial will be to assess the safety, tolerability and immunogenicity (elicited antibody responses) of a prime-boost regimen of GOVX-B11, in combination with protein boosts. HVTN 132 is expected to commence patient enrollment in mid-2019.
HVTN 132, formally titled “A phase 1 clinical trial to evaluate the safety and immunogenicity of a prime-boost vaccine regimen of GEO-D02 DNA and MVA/HIV62B with and without B.63521Δ11gp120mutC and IHV01 gp120 Env proteins in healthy, HIV-uninfected adult participants”, will be conducted by the HVTN through the support of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
GOVX-B11 consists of two vaccine components – a recombinant DNA vaccine and a recombinant live MVA (modified vaccinia Ankara) virus vaccine. Both produce non-infectious virus-like-particles (VLPs) in the cells of the vaccinated person. The DNA vaccine is intended to prime the immune response, and the MVA to boost the immune response. The HVTN has previously tested various doses and regimens of GOVX-B11 in trials involving approximately 500 participants where it has shown excellent safety and durable immunogenicity. The protein boosts are being tested for their ability to enhance the antibody response elicited by GOVX-B11 to gp120. The B.63521Δ11gp120mutC gp120 protein was developed by the Center for HIV/AIDS Vaccine Immunology-Immunogen Design at Duke University Human Vaccine Institute. The gp120-based IHV01 vaccine was developed by the Institute of Human Virology of the University of Maryland School of Medicine.
Harriet L. Robinson, PhD, Director of HIV Vaccines at GeoVax, commented, “HVTN 132 is the natural progression from the HVTN 114 trial, which is evaluating the durability of immune responses elicited by GOVX-B11 and the effects of late MVA, protein, or MVA+protein boosts on the elicitation of antibody by GOVX-B11. Preliminary results from HVTN 114 were presented at the HIV Research for Prevention (HIVR4P) conference in October this year and demonstrated that these late boosts significantly enhanced the antibody responses – by more than 600-fold for the most effective regimen (MVA+protein) tested. HVTN 132 is designed to further evaluate the prime-boost strategy with newly developed proteins. Both HVTN 114 and HVTN 132 will contribute data critical in determining the regimen to be used in a future phase 2b efficacy trial.”
GeoVax has designed GOVX-B11 to prevent infection from the clade B subtype of HIV prevalent in the Americas, Australia, Japan and Western Europe. Although overall HIV incidence rates have declined in recent years, some groups such as Hispanic/Latino gay and bisexual men continue to see an increase in incidence, which, according to data from the U.S. Centers for Disease Control and Prevention (CDC), increased by 14% in the U.S. over the 2011-15 period. The CDC also reports a disproportionate impact of HIV on African-Americans, who accounted for 44% of HIV diagnoses in 2016, although they comprise only 12% of the U.S. population. Despite substantial progress made in expanding access to HIV/AIDS treatment and prevention options, the development of an HIV vaccine remains critical to bringing an end to the HIV/AIDS epidemic. This is particularly important as healthcare costs among those living with HIV continue to grow.
About the HIV Vaccine Trials Network (HVTN)
The HVTN is the world’s largest publicly funded collaboration bringing together global study participants, communities and acclaimed scientific leadership on a journey to find a safe and effective HIV vaccine to prevent new HIV infections in the future. The HVTN is headquartered at the Fred Hutchinson Cancer Research Center in Seattle, Washington. Website: www.hvtn.org
GeoVax Labs, Inc., is a clinical-stage biotechnology company developing human vaccines against infectious diseases using its MVA-VLP vaccine platform. GeoVax was the winner of the 2018 “Best Biotech” Vaccine Industry Excellence Awards, a finalist for the 2018 “Best Prophylactic Vaccine” Award for its Zika vaccine at the World Vaccine Congress, as well as a finalist for Pipelines of Promise at Buzz of Bio 2018. The Company’s development programs are focused on vaccines against HIV, Zika, hemorrhagic fever viruses (Ebola, Sudan, Marburg, Lassa) and malaria. GeoVax also is evaluating 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. 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.