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GeoVax Awarded $2.4 Million from U.S. Department of Defense to Advance Lassa Fever Vaccine
ATLANTA, GA, September 26, 2018 – GeoVax Labs, Inc. (OTCQB: GOVX), a biotechnology company developing innovative human vaccines, announced today that the U.S. Department of Defense (DoD) has awarded the Company a $2,442,307 cooperative agreement in support of its novel Lassa Fever (LF) vaccine development program. The grant was awarded by the U.S. Army Medical Research Acquisition Activity pursuant to the Peer Reviewed Medical Research Program (PRMRP), part of the Congressionally Directed Medical Research Programs (CDMRP). In addition to the grant funds provided directly to GeoVax, DoD will also fund testing of the GeoVax vaccine by U.S. Army scientists under a separate subaward.
The project award, entitled “Advanced Preclinical Development and Production of Master Seed Virus of GEO-LM01, a Novel MVA-VLP Vaccine Against Lassa Fever”, will support generation of immunogenicity and efficacy data for GeoVax’s LF vaccine candidate in both rodent and nonhuman primate models, as well as manufacturing process development and cGMP production of vaccine seed stock in preparation for human clinical trials. The work will be performed in collaboration with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), the Geneva Foundation, and Advanced Bioscience Laboratories (ABL).
GeoVax previously announced that its LF vaccine candidate, GEO-LM01, provided 100% protection after a single intramuscular immunization of mice, which were subsequently exposed to a lethal dose of a model challenge virus delivered directly into the brain. The Company also announced in April 2018 the award of a Fast Track Phase I/II Small Business Innovative Research (SBIR) grant from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to construct and test second-generation LF vaccine candidates in collaboration with Scripps Research and the Institute of Human Virology at the University of Maryland School of Medicine.
Farshad Guirakhoo, PhD, Chief Scientific Officer at GeoVax, commented, “The work funded by this award will significantly advance the development of our vaccine candidate, GEO-LM01, which has already demonstrated impressive preclinical results. These studies will be complementary to those being funded by our separate SBIR grant from NIAID/NIH which is supporting development of a potentially “universal” LF vaccine by eliciting broadly neutralizing antibodies to the Lassa virus (LASV) glycoprotein designed by Scripps Research. Both avenues are building upon previous work that demonstrates the full protective efficacy of GeoVax’s MVA recombinant vaccines against dangerous diseases after a single inoculation. We are pleased now to have non-overlapping support for our LF vaccine program from multiple federal agencies and excited to be working with influential USAMRIID scientists to combat a pathogen of major concern to our armed forces.”
GEO-LM01 uses GeoVax’s proven Modified Vaccinia Ankara (MVA) Virus-Like Particle (VLP) vaccine platform that has been shown to be safe and to induce durable antibody and T cell responses in multiple human clinical trials for GeoVax’s prophylactic HIV vaccine. In contrast to other LF vaccines in development that rely on a single glycoprotein antigen, GEO-LM01 includes an additional matrix protein that forms VLPs with the LASV glycoproteins. Upon infection of human cells, the MVA-driven expression of the two proteins leads to the formation of non-infectious VLPs that bear natively-folded glycoproteins on their surface, triggering an effective and durable immune response.
Using the same MVA-VLP platform, a single dose of GeoVax’s Ebola (EBOV) vaccine has been shown to protect 100% of rhesus monkeys against a lethal dose of EBOV challenge. Similarly, a single dose of GeoVax’s Zika vaccine showed full protection in preclinical animal models. GeoVax is also developing vaccines against Sudan virus (SUDV) and Marburg virus (MARV), two other lethal hemorrhagic fever viruses for which no effective vaccine currently exists. In addition to developing the four individual vaccines (EBOV, LASV, SUDV, MARV), the Company’s ultimate goal is to combine them into a single tetravalent vaccine to provide broad protection for individuals at risk for these viruses.
Commenting on the award, GeoVax CEO, David Dodd stated, “This validation of the value of our proprietary, patented applications of MVA-VLP technology demonstrates our continued progress in vaccine development in areas of critical healthcare significance worldwide. Our commitment is to further contribute to improved healthcare, providing an attractive investment return to our shareholders, while providing an exciting and motivating career development opportunity for our outstanding staff. We look forward to forthcoming, additional reports of the progress of our product development programs, including additional collaboration agreements in other critical areas.”
About Lassa Fever
Lassa Fever is caused by an infection with LASV, a member of the Arenaviridae virus family. The virus can cause severe hemorrhagic illnesses with up to 50% case fatality rates in an overlapping region with EBOV. The virus is transmitted to humans by natal multimammate rat or African rats (e.g. by direct consumption in food, contact with urine and droppings or inhalation of virus particles from the excreta of infected animals) that live in large numbers in agricultural areas near human habitations. The virus can also be transmitted from human to human through nosocomial infections. In contrast to the unpredictable epidemics of filoviruses such as EBOV, LF is endemic in West Africa with an annual incidence of over 300,000 and leading to 5,000 to 10,000 deaths. Recent study data suggests that the number of annual LF cases may in fact be significantly higher, with three million infections and 67,000 deaths (placing upwards of 200 million individuals at risk). Today, no treatment or vaccine is available to stem LF epidemics, even though LF kills more people in one year than the EBOV did in the last 41 years after its first epidemic in 1976 in West Africa.
The urgent need for a LF vaccine is exemplified by the record-high ongoing outbreak of LF in Nigeria with nearly 2,500 suspected cases and 132 deaths in 2018 according to the Nigeria Centre for Disease Control report on September 2, 2018. The infection of 39 healthcare workers highlights the need for infection prevention and control measurements to stop the spread of disease in healthcare workers and prevent cross-border spread into neighboring countries.
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.