ATLANTA, GA, March 11, 2019 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE – GeoVax Labs, Inc. (OTCQB: GOVX), a biotechnology company developing human vaccines and immunotherapies using its novel viral vector platform technology, today provided an update on its progress and development programs.
David Dodd, GeoVax President and CEO, commented, “We continue to advance GeoVax’s development programs on multiple fronts with an expanding list of world-class government, academic and corporate collaborators, as further described in this update. I am pleased with what the GeoVax team has accomplished during 2018 and so far in 2019, but I also recognize that our constrained capital resources continue to limit our ability to meaningfully advance our products as rapidly as we would like. Going forward, we will continue to evaluate options to secure the capital needed to proceed with our business plan, especially to advance further programs into human clinical testing. We view this as critical to our overall corporate development and enhancement of shareholder value. I remain highly optimistic about the future of our company and I look forward to sharing additional news in the coming months. All of us at GeoVax wish to thank our shareholders for their continued support as GeoVax progresses toward a status of having multiple clinical programs underway, addressing various infectious diseases and cancer indications, having a capital structure that supports continued execution of our strategy and business plan.”
A few highlights from 2018 and early 2019 include:
Immuno-oncology - A Promising and Expanding Program. We began 2018 with a single program in this area (tumor-associated MUC1 vaccines) supported by two collaborations (University of Pittsburgh and ViaMune) and that work is continuing to expand and advance. During 2018, we added four more collaborations to expand our footprint in this space -- with Vaxeal Holding SA (Cyclin B1 tumor-associated antigen), Emory University (HPV-related head and neck cancers), Virometix AG (also for HPV-related cancers), and Leidos, Inc. (multiple potential cancer targets). We believe immuno-oncology to be important for the future of GeoVax and we intend to vigorously pursue development of these programs. Raising sufficient capital will be key to rapidly advancing in this area.
Defense Department Grant - Our First Entrée into the U.S. Government Biodefense System. In September the U.S. Department of Defense (DoD) awarded us a $2.4 million grant to support our Lassa Fever vaccine program. The DoD will also fund testing of our vaccine by U.S. Army scientists at USAMRIID under a separate sub-award. This grant represented an important advance by GeoVax into the critical area of biodefense which we believe represents a significant growth area for the application of our technology and expertise.
HIV “Cure” Program - New, Exciting Possibilities. Our collaboration with American Gene Technologies International, Inc. (AGT), for use of our vaccine in combination with AGT’s gene therapy for development of a functional cure for HIV, is on track to enter a Phase 1 trial sponsored by AGT. AGT anticipates starting the trial during the second half of 2019. We are also in discussions with two other consortiums for the possible use of our vaccine in similar efforts toward developing a cure for HIV infection. We expect that one or both of these studies may begin in late 2019 or early 2020.
HIV “Prevention” Program - Continued Progress with NIH Support. In October, positive results from HVTN 114, a phase 1 trial of our preventive HIV vaccine, were presented at the HIVR4P conference in Madrid. The clinical trial program for our preventive HIV vaccine continues to be supported by the NIH and the HIV Vaccine Trials Network (HVTN), with the next study (HVTN 132) expected to commence later this year. Furthermore, during President Trump’s recent State of the Union address, he committed to pursuing the elimination of HIV within the next decade. We view our preventive vaccine developments as being critical and core to this initiative.
NIH Support for our Lassa Fever and Zika Programs. In April the NIH awarded us a Fast-Track Phase I/II SBIR grant for our Lassa Fever vaccine with an anticipated total project budget of up to $1.9 million. In May we received $300,000 for the second year of the NIH SBIR grant for our Zika vaccine. Both of these grants support preclinical testing of our vaccines in non-human primates in preparation for human clinical trials.
New Collaborations - New Opportunities. In addition to the new collaborations described above, we continue to work with the Burnet Institute in Australia on our malaria vaccine program and with Georgia State University on our Hepatitis B immunotherapy program. We also added new collaborations with Scripps Research, Institute of Human Virology, and the Geneva Foundation for our Lassa Fever program; and with Enesi Pharma for developing a novel vaccine delivery platform utilizing several of our vaccines. And we recently expanded our relationship with Leidos, adding a malaria program to our existing cancer collaboration. These collaborations provide multiple opportunities for success and demonstrate the high level of interest our MVA-VLP platform generates within the scientific and business development community.
Scientific and Peer Recognition. We are honored that our accomplishments were recognized through our selection for the 2018 “Best Biotech” Vaccine Industry Excellence (VIE) Award, and a finalist for the “Best Prophylactic Vaccine” for our Zika vaccine candidate at the 18th World Vaccine Congress in Washington DC, as well as a finalist for 2018 Pipelines of Promise at the Buzz of BIO in Boston. Again, in 2019, GeoVax has made it through as a finalist in two categories for this year’s VIE Awards on April 15, at the 19th World Vaccine Congress -- for the “Best Therapeutic Vaccine Award” (MVA-VLP-MUC1 cancer) and “Best New Vaccine Technology Award” (MVA-VLP platform). This now marks two years in a row of recognition by industry peers of our continued progress in applying our expertise and technology to advance highly promising vaccines for the benefit of people worldwide.
About GeoVax
GeoVax Labs, Inc., is a clinical-stage biotechnology company developing human vaccines and immunotherapies against infectious diseases and various cancers using its MVA-VLP vaccine platform. 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.
Forward-Looking Statements
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.