GeoVax stock rises after NIH grant to advance COVID-19 vaccine development
Surging Stock
Early in 2021 shares of GeoVax Labs Inc.-- a clinical-stage biotech company committed to developing safe and effective vaccines and immunotherapies against cancers and infectious diseases — were surging nearly 100 percent after the company announced that it had received an NIH grant to advance COVID-19 vaccine development.
The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, awarded the company a Small Business Innovative Research grant in support of its development of a vaccine against SARS-CoV-2, the virus that causes COVID-19. The phase 1 grant is designed to 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.
GeoVax development programs use a novel patented Modified Vaccinia Ankara-Virus Like Particle (MVA-VLP) based vaccine platform. 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 can mimic 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 can elicit durable immune responses in the host similar to a live-attenuated virus, while providing the safety characteristics of a replication-defective vector, according to the company.
GeoVax’s current development programs are focused on preventive vaccines against COVID-19, HIV, Zika Virus, hemorrhagic fever viruses (Ebola, Sudan, Marburg, and Lassa), and malaria, as well as therapeutic vaccines against multiple cancers. The company has designed a preventive HIV vaccine candidate to fight against the subtype of HIV prevalent in the commercial 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 NIH. GeoVax’s HIV vaccine is also part of two separate collaborative efforts to apply its innovative gene therapy approach toward a functional cure for HIV.
The GeoVax approach uses recombinant DNA or recombinant viruses to produce VLPs in the person being vaccinated. In human clinical trials of its HIV vaccines, the company has demonstrated that the VLPs, expressed in the cells of the person being vaccinated, are extremely safe, while eliciting both strong and durable humoral and cellular immune response. Humoral immunity produces an antibody-mediated immune response whereas cellular immunity produces a cell-mediated immune response. B cell mainly regulates the humoral immunity whereas T cell regulates the cellular immunity.)
VLPs mimic the form of viruses and thereby train the body's immune system to recognize the authentic virus should it appear. VLPs also train the immune system to recognize and kill infected cells to control infection and reduce the length and severity of disease. When VLPs for viruses like COVID-19, Ebola, Marburg, Lassa fever or HIV are produced in vivo, they include not only the protein antigens, but also consist of membranes from the vaccinated individual's cells displaying vaccine proteins. In this way, they are highly similar to the virus generated in a person's body during a natural infection. VLPs produced externally, by contrast, are less familiar to the immune system due to the manner in which they are produced. Finally, and of critical importance, by producing VLPs in vivo, we avoid cumbersome purification issues associated with in vitro production of VLPs.
The company’s business strategy is to advance its products through regulatory registration while also seeking partnership or licensing arrangements that might otherwise maximize the value to its shareholders. GeoVax also engages third party resources/expertise through collaborations and partnerships for preclinical and clinical testing with well-validated industry, government and other relevant entities.
GeoVax CEO David Dodd updated investors and analysts on the company and his perspective in a recent conference call. As he explained, “There's increasing evidence that the COVID-19 virus will continue to evolve, requiring expanded virus variant coverage, otherwise requiring annual reconfigured vaccines, similar to what is necessary with annual influenza vaccination. We hope to change that paradigm, encompassing potential variants before they emerge versus chasing the evolving virus as will be likely required of various competitive technologies. In November 2020, the NIH issued a request for proposals for pan-coronavirus vaccine development programs. That is exactly what we are pursuing using our differentiated technology focused on developing a single-dose vaccine with minimal or no refrigeration required.”
He added, “We are in the final stages of small-animal testing with our various COVID-19 vaccine candidates and we hope to report these data in the coming months. As a reminder, the primary advantage of our MVA-VLP platform is that it can incorporate a large genetic coding capacity, which allows us to include multiple genes for a given target. For COVID-19, our preventative vaccine constructs not only include the Spike, or S protein, but also the matrix and envelope proteins, M & E proteins, which serve as additional targets for cellular immune responses and should not be significantly impacted by variants that are evolving within the population. This ultimately facilitates our goal of developing a single-dose, universal, pan-coronavirus vaccine.”
In other infectious diseases, GeoVax continues to make advances with its vaccine pipeline. The Lassa vaccine is now in animal testing through non-human primates, with results expected later this year. This program is being supported by the U.S. Army and will also fund the preparation of cGMP material for clinical development. Both the Marburg and Sudan vaccines, having previously demonstrated 100% protection in rodent models, are being tested via the NIH preclinical services program through non-human primates at no cost to GeoVax. The company expects the results of the animal testing in 2021.
GeoVax malaria vaccine candidates have recently entered animal testing with the results expected later this year. The Zika virus vaccine is ready to proceed into clinical development, having demonstrated successful preclinical results, including avoiding the risk of antibody-dependent enhancement of infection against Dengue or other flaviviruses. Similarly, the Ebola virus vaccine is ready to proceed into clinical development, having demonstrated 100% protection from a single-dose without any adjuvants or booster necessary.
Finally, according to Dodd, GeoVax continues to make progress with its efforts in cancer immunotherapy. The company is working to advance its lead MUC1 candidate into the clinic in 2021.
According to Dodd, “We are applying the same approach that we use in constructing our infectious disease vaccines to cancer. Our cancer immunotherapy concept is to combine a tumor-associated antigen vaccine with potent anti-tumor agents such as immune checkpoint inhibitors (ICI). Mucin-1 TAA or MUC1 is highly expressed in many different solid tumors and, in a humanized mouse model study, our MVA-VLP, MUC1 TAA vaccine construct combined with a checkpoint inhibitor resulted in a 57 percent difference in tumor growth between the cohort receiving our vaccine/ICI combination compared to a cohort that didn’t receive our combination treatment. In a preventive humanized mouse model, intended to reflect prevention of tumor recurrence, our MVA-VLP MUC1 vaccine plus a MUC1 peptide provided 100 percent prevention of tumor development versus 100% development of the tumor in the cohort that didn't receive the GeoVax vaccine peptide combination. These highly promising results have encouraged our focus on advancing our cancer immunotherapy program into clinical development as soon as possible.”
He concluded, “In summary, we continue to strengthen our IP portfolio, now having over 70 granted or pending patent applications spread over 20 patent families. We are confident that we have a strong IP position, providing an increasingly more competitive position. We have a compelling pipeline focused on major medical needs, providing significant commercial market opportunities with near-term value milestones. Included in our development portfolio are six indications that qualify for the FDA priority voucher program, most of which are continuing to advance with non-dilutive funding.”