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ATLANTA, GA -- (Marketwired) -- 08/02/16 --
GeoVax Labs, Inc. (OTCQB: GOVX), a biotechnology company developing human vaccines, announced today that the National Institute of Allergy and Infectious Diseases, (NIAID) part of the National Institutes of Health (NIH) has awarded it a Staged Vaccine Development contract to further develop GeoVax's preventive HIV vaccine (GOVX-B11) and to manufacture the DNA component of GOVX-B11 for use in advanced human clinical trials.
The base portion of the contract, with a value of $199,442, will support preparatory work for initiation of manufacturing. The contract also includes $7.6 million in additional development options that may be exercised by NIAID, bringing the total potential value of the contract to $7.8 million. The scope of the product development plan covered by the contract includes process development, cGMP-compliant manufacturing of vaccine bulk drug substance and final drug product, testing and characterization of the manufactured products, stability studies, and regulatory filings.
The multi-year contract will pay 100% of the manufacturing cost of the DNA vaccine component of GeoVax's HIV vaccine candidate, GOVX-B11. The amount of DNA vaccine to be produced pursuant to the full contract will be sufficient for efficacy testing of GOVX-B11 in the presence and absence of a gp120 protein boost.
Robert McNally, PhD., GeoVax's President and CEO, commented, "With NIAID's award, GeoVax is advancing its GOVX-B11 vaccine in clinical trials for prevention of disease caused by HIV-1 clade B, the subtype of the HIV virus prevalent in North American and Western Europe. Production of the clinical supply of our vaccine is a critical step in preparation to move GOVX-B11 into advanced human clinical trials. The DNA vaccine component of GOVX-B11 to be manufactured with support from this contract, combined with our already-produced MVA vaccine, will give us ample vaccine supplies for the clinical trials being contemplated."
Dr. McNally continued, "As stated by NIAID in the original contract solicitation, the primary intent of the contract is to provide support for advanced development and manufacture of HIV vaccine candidates that have demonstrated success in non-human primate challenge studies or early human clinical trials, and which have demonstrated manufacturing feasibility. We are thankful to NIAID for recognizing our vaccine's potential, and for their support of our program through this contract award and through their continued support of our clinical trials."
About GOVX-B11 and HIV
GOVX-B11 has been developed for use against the clade B epidemic of HIV in the Americas and Western Europe. Despite advancements in drug treatment, data from the CDC indicates that only a small minority (~11%) of HIV-infected Americans successfully control their infections with drugs. HIV diagnosis rates are increasing in American youth faster than in any other age groups in the US. In those aged 13 to 24, the incidence of HIV increased at an estimated average annual rate of 10.5% between 2002 and 2011. With the increasing burden of the epidemic, healthcare costs are also growing. The development of an effective HIV vaccine would be critical to bringing about a durable end to the HIV/AIDS pandemic and remains a top priority for NIH.
GOVX-B11 consists of two vaccine components -- a recombinant DNA vaccine and a recombinant MVA (modified vaccinia Ankara) vaccine to prime and boost a patient's immune responses, respectively. Both the DNA and MVA vaccines produce non-infectious virus-like particles in the cells of the vaccinated person. With NIAID's support, GOVX-B11 has been tested at various doses and regimens by the HIV Vaccine Trials Network (HVTN) in trials involving approximately 500 participants where it has shown excellent safety and reproducible immunogenicity.
The next clinical testing of GOVX-B11 will evaluate the use of gp120 protein boosts co-delivered with the MVA boosts with the anticipation that efficacy testing will be conducted in the presence and absence of the added protein boost. A phase 1 trial (HVTN 114) will first evaluate the effect of late boosts (gp120 protein and the GeoVax MVA vaccine) in individuals previously vaccinated with GOVX-B11. An Investigational New Drug (IND) application for HVTN 114 was filed with the U.S. Food and Drug Administration on June 28, 2016, and GeoVax anticipates this trial could begin patient enrollment in September. Concurrently, an ongoing preclinical study in non-human primates is evaluating two additional proteins specifically chosen as boosting agents for GOVX-B11, and planning is underway for a phase 1 trial to evaluate the safety and immunogenicity of these proteins in humans.
GeoVax Labs, Inc., is a clinical-stage biotechnology company developing human vaccines against infectious diseases using its MVA-VLP vaccine platform. The Company's development programs are focused on vaccines against HIV, Zika Virus, and hemorrhagic fever viruses (Ebola, Sudan, Marburg, Lassa). GeoVax also recently began a program 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 virus-like particles (VLPs) from the cells of the person receiving the vaccine. The production of VLPs in the person being vaccinated mimics 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.Robert T. McNally, Ph.D. GeoVax Labs, Inc. 678-384-7220 NEXT ARTICLE
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