Company Ready to Advance COVID-19 Vaccine Candidates to Animal Efficacy Testing, Manufacturing Scale-Up, and Human Clinical Trials
ATLANTA, GA, March 30, 2020 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE --GeoVax Labs, Inc. (OTC: GOVX), a biotechnology company developing human vaccines and immunotherapies against infectious diseases and cancer, today commented on the passage of the Coronavirus Aid, Relief, and Economic Security Act (CARES ACT), which was signed into law by President Trump on March 27, 2020.
Among the many provisions of this unprecedented $2 trillion economic stimulus bill, $27 billion of emergency funding is appropriated for the “Public Health and Social Services Emergency Fund” to prevent, prepare for, and respond to the current coronavirus pandemic, including the development of countermeasures and vaccines. These appropriations include not less than $3.5 billion for the Biomedical Advanced Research and Development Authority (BARDA) for manufacturing, production and purchase of vaccines, therapeutics and diagnostics.
GeoVax is using itsGV-MVA-VLPTM vaccine platform and expertise to develop vaccine candidates using genetic sequences from SARS-CoV-2, the virus responsible for the ongoing COVID-19 outbreak. Three vaccines have been designed, constructed, and characterized. The Company is now prepared to advance the vaccines into animal testing to down select to one candidate based on their safety, immunogenicity and efficacy profiles. The selected candidate will be used for manufacturing scale-up, and initial human clinical trials to determine the appropriate dose and to further confirm its safety and immunogenicity.
GeoVax’s GV-MVA-VLPTM vaccine platform has been previously demonstrated in animal studies against a variety of infectious challenges (Ebola, Marburg, Zika, HIV) to be an excellent candidate for addressing epidemic threats, with a desirable safety profile and demonstration of 100% single-dose efficacy. In human clinical trials involving 500 subjects, the Company’s HIV vaccines have likewise shown an advantageous safety profile.
David Dodd, GeoVax’s President and CEO, commented, “We applaud President Trump and the bipartisan leadership for their quick negotiation and enactment of this historic legislation. The emergency funding appropriated toward medical countermeasures including vaccines will be of vital importance in the fight against COVID-19.”
Mr. Dodd continued, “We continue our interactions with BARDA and other international agencies, emphasizing the critical need of funding support for multiple vaccine approaches to the coronavirus pandemic, including the rationale for simultaneous at-risk activities, normally done sequentially, in order to shorten the overall development timeline. The seriousness of this ongoing global health crisis and the risk of future outbreaks requires new ways of thinking about vaccine development. We are focused on accelerating the advancement of our vaccines into critical testing, while simultaneously preparing the requisite manufacturing processes to minimize the time to human testing.”
About Novel Coronavirus Disease (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, SARS 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 29, 2020, the number of reported COVID-19 infections exceeds 720,000 globally (>140,000 in the U.S), with more than 34,000 deaths (>2,400 in the U.S). The situation is 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.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing human vaccines against infectious diseases and cancer using a novel proprietaryvaccine 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 the person receiving the vaccine (in vivo).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-VLPTMderived 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.
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 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.
Contact:
GeoVax Labs, Inc.
investor@geovax.com
678-384-7220