Company Focused on Single-dose Vaccine Against Multiple COVID Strains
ATLANTA, GA, January 11, 2021 – GeoVax Labs, Inc. (NasdaqCM: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, announced today that the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has awarded the Company a Small Business Innovative Research (SBIR) grant in support of its development of a vaccine against SARS-CoV-2, the virus that causes COVID-19.
The Phase 1 grant, titled, “Preclinical Development of GV-MVA-VLP Vaccines Against COVID-19,” will support the ongoing design, construction and preclinical testing of GeoVax’s vaccine candidates in preparation for human clinical trials. The efficacy testing will be performed in collaboration with the University of Texas Medical Branch (UTMB).
GeoVax is leveraging its GV-MVA-VLPTM platform to address the global need for an effective and safe SARS-CoV-2 vaccine. Unique among other vaccines under development, the experimental GeoVax candidates are specifically designed to provide a broader and more long-lived level of protective immunity against SARS-CoV-2 while avoiding the potential side effects that can limit vaccine utility and acceptance. GeoVax’s vaccine candidates will be tested for antigen expression and genetic stability under conditions designed to simulate those in manufacturing, which will demonstrate the likely suitability of each vaccine construct as a candidate for full-scale production and clinical testing.
Mark Newman, Ph.D., GeoVax’s Chief Scientific Officer commented, “The first generation of SARS-CoV-2 vaccines are based on the ‘Spike (S)’ protein and are designed to induce antibodies that block infection of human cells, an effect referred to as virus neutralization. The GV-MVA-VLP platform provides the opportunity to design and test vaccine candidates that differ significantly through the inclusion of multiple SARS-CoV-2 proteins that are presented to the immune system as virus-like particles (VLPs). Our goal is to safely increase vaccine potency and efficacy by inducing both neutralizing antibody and cellular immune responses to optimize the level of protection against existing and potential new variants of COVD as well as establish immunological memory to provide multi-year protection. Vaccines using the GV-MVA-VLP platform developed for other pathogens have proven to be efficacious with a single dose, having strong durability which would be a significant advantage for SARS-CoV-2 global vaccination campaigns.”
David Dodd, GeoVax’s Chairman & CEO, added, “We are pleased to receive this Phase 1 SBIR funding award, which will supplement the internal resources allocated to our COVID-19 vaccine program and accelerate our progress toward human clinical trials. We appreciate and welcome this support from NIH/NIAID, which follows our signing of a Patent and Biological Materials License Agreement providing GeoVax with access to key NIAID patent rights, and which provides GeoVax with nonexclusive rights to develop, manufacture and commercialize our COVID-19 vaccine. While we continue to advance our COVID-19 vaccine program, we remain in discussions and negotiations related to additional funding support that will further accelerate our progress into clinical testing and supply chain preparation. We anticipate that additional vaccines, such as ours, will be necessary against COVID-19, as well as potentially new strains and variants, requiring broader immune response, strong durability, exquisite safety within various cohort populations and minimal refrigeration for distribution and supply throughout the world. These attributes represent the focus of our overall “COVID-X” vaccine program (think “COVID-20, -21”, etc.).”
Coronaviruses are common in many species of animals, including bats and birds. These viruses can evolve to cross the animal species and infect humans and quickly spread from person to person resulting in lethal but rare respiratory infections. Recent epidemics with SARS and MERS coronaviruses resulted in 774 and 858 deaths, respectively. Since 2015 there have not been any cases of SARS and MERS reported, but in January 2020, World Health Organization (WHO) identified a novel coronavirus, recently named SARS-CoV-2, in the city of Wuhan, China. On January 31, 2020, the WHO declared the novel coronavirus to be a global health emergency, and on March 11, 2020 the WHO declared a global pandemic. Worldwide, more than 85 million people have been infected (over 20 million in the U.S.), with nearly 2 million deaths (over 350,000 in the U.S). The situation is fluid, with the infection and death statistics changing significantly on a regular basis.
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing human vaccines against infectious diseases and cancers using a novel patented Modified Vaccinia Ankara-Virus Like Particle (MVA-VLP) based vaccine platform. On this platform, MVA, a large virus capable of carrying multiple 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 MVA-VLP derived vaccines have been shown to elicit durable immune responses in the host similar to a live-attenuated virus, while providing the safety characteristics of a replication-defective vector. The goal of the GeoVax technology (GV-MVA-VLPTM) is to provide high efficacy in a single dose, without the need for additional immune response components (“adjuvants”), strong durability (“minimizing the need for boosters”), the highly-validated safety of MVA, minimal refrigeration requirements, and cost-effective manufacturing.
GeoVax’s current development programs are focused on preventive vaccines against COVID-19, Zika Virus, hemorrhagic fever viruses (Ebola, Lassa, Marburg and Sudan), HIV and malaria, as well as therapeutic vaccines against multiple cancers. The Company has successfully completed six human clinical trials related to HIV, having designed a preventive HIV vaccine candidate to fight against the subtype of HIV prevalent in the geographic markets of the Americas, Western Europe, Japan, and Australia. Human clinical trials for this program are managed by the HIV Vaccine Trials Network (HVTN) with the support of the National Institutes of Health (NIH). GeoVax’s HIV vaccine is also part of two separate collaborative efforts to apply its innovative approach toward a functional cure for HIV, addressing those already infected with HIV.
This press release contains forward-looking statements regarding GeoVax’s business. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current plans and expectations about our product development, future events and trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. 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, the impact of the COVID-19 pandemic continues, and other factors, over which GeoVax has no control.
Further information on our risk factors is contained in our most recent Quarterly Report on Form 10-Q that we have filed with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
GeoVax Labs, Inc.