GeoVax Progresses in Coronavirus (COVID-19) Vaccine Development Program
- Three Vaccine Candidates Completed
- Nearing Readiness for Animal Efficacy Testing and Human Clinical Trials
ATLANTA, GA, March 18, 2020 – GeoVax Labs, Inc. (OTC: GOVX), a biotechnology company developing human immunotherapies and vaccines against infectious diseases and cancer, today provided an update on its development of a vaccine for prevention/control of novel coronavirus disease (COVID-19) caused by SARS-Cov-2 coronavirus. GeoVax is using its GV-MVA-VLPTM vaccine platform and expertise to design and construct vaccine candidates using genetic sequences from the virus responsible for the ongoing COVID-19 outbreak originating in Wuhan, China.
Farshad Guirakhoo, PhD, GeoVax’s Chief Scientific Officer, stated, “We are pleased with a rapid progress with design, construction and in vitro characterizations of our three vaccine candidates. From here, we will narrow to one vaccine candidate based on the safety, immunogenicity and protective efficacy of our PreMaster Seed Viruses observed in upcoming animal studies. The final candidate will then proceed directly to manufacturing and initial human clinical testing for safety and immunogenicity.”
David Dodd, GeoVax’s President and CEO, commented, “Safety, efficacy, and durability of protection (long-lasting) are the expected characteristics of our GV-MVA-VLPTM vaccine platform. Our platform has a demonstrated track record of safety in humans through our HIV vaccine program, and the preclinical testing results we’ve seen with our HIV, Ebola and Zika vaccines leads us to believe that our COVID-19 vaccine will demonstrate a similarly strong efficacy and durability profile.”
“We have initiated discussions and submitted applications with various U.S. and international funding agencies,” Mr. Dodd continued. “The seriousness of this global health crisis warrants a broad disbursement of funds in order to advance multiple vaccine approaches to human clinical studies. Just last week, I was in Washington, DC visiting with various members of Congress and their staffs to emphasize the critical need of funding and support behind our accelerated COVID-19 vaccine development program, and we look forward to advancing our program as rapidly as ethically possible. With appropriate and timely funding, our goal is to advance a vaccine candidate to human clinical trials before the end of this year…much faster than the typical 12-18 months normally expected.”
Mr. Dodd concluded, “We also continue to be in frequent communication with BravoVax, our vaccine development collaborator in Wuhan, China. Under our January letter of intent, and upon completion of a definitive agreement, BravoVax will provide testing and manufacturing support, as well as direct interactions with Chinese authorities, for a parallel regulatory pathway to what we will pursue in the United States.”
About Novel Coronavirus (COVID-19)
Coronaviruses (CoV) are a large family of viruses that cause illness ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). Novel coronavirus, severe acute respiratory syndrome coronavairus-2 (SARS-Cov-2) which originated in Wuhan, China, is a new strain that had not been previously identified in humans. Common signs of infection include respiratory symptoms, fever, cough, shortness of breath and breathing difficulties. In more severe cases, infection can cause pneumonia, severe acute respiratory syndrome, kidney failure and even death. There is currently no vaccine available to treat or prevent COVID-19 (coronavirus disease) or any other CoV infections.
As of March 17, 2020, the number of reported COVID-19 infections is rapidly approaching 200,000 cases, with nearly 8,000 deaths. For the first time, the number of cases and deaths outside China has exceeded those of inside China and the situation is still fluid, with case reports being updated daily. The current situation report from the U.S. Centers for Disease Control and Prevention can be found here. Situation reports from the WHO are accessible here.
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing human vaccines against infectious diseases and cancer using a novel proprietary vaccine platform (GV-MVA-VLPTM). On this platform, MVA, a large virus capable of carrying several vaccine antigens, expresses proteins that assemble into VLP immunogens within (in vivo) the 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. The GV-MVA-VLPTM derived vaccines can elicit durable immune responses in the host similar to a live-attenuated virus, while typically providing the safety characteristics of a replication-defective vector.
GeoVax’s current development programs are focused on preventive vaccines against COVID-19, HIV, Zika, hemorrhagic fever viruses (Ebola, Sudan, Marburg, and Lassa), and malaria, as well as therapeutic vaccines against chronic Hepatitis B infections and multiple cancers. The Company has developed preventive HIV vaccine candidate (GOVX-B11) for the clade B subtype of HIV prevalent in the Americas, Western Europe, Japan, and Australia and the clade C subtype prevalent in Africa and India. GOVX-B11 is scheduled for inclusion in an upcoming human clinical trial managed by the HVTN with the support of the National Institutes of Health (NIH). GeoVax’s clade B HIV vaccine is also part of collaborative efforts to develop an immunotherapy as a functional cure for HIV.
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 and BravoVax will enter into a binding agreement, 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.
GeoVax Labs, Inc.