GeoVax utilizes a proprietary, novel Modified Vaccinia Ankara (MVA) Virus-Like Particle (VLP) platform technology that has been demonstrated safe and effective and has shown the ability to induce rapid immunity, durability and protection against a wide range of pathogens in animal models of Ebola, Marburg, Lassa, and Zika. The GV-MVA-VLP™ platform technology is built on a vector system that is optimized for high expression and stabilization during manufacture. The company has a patent estate of 58 granted or pending patent application encompassing 15 patent families.
Vaccines built on the GeoVax platform offer several important attributes:
- Safety in all target populations - The safety of previous MVA has been demonstrated in over 150,000 subjects, including the immuno-compromised and the safety of the GeoVax vaccine technology has been demonstrated in ~500 subjects.
- Rapid elicitation of protection - MVA-VLP vaccines elicit protective immunity in animal models of Ebola, Lassa, and Zika after a single dose in under two weeks. MVA vaccines can also be used simultaneously primed with DNA, protein, or peptide vaccines for an enhanced effect.
- Powerful and durability response - MVA-VLP vaccines have a high “carrying capacity” to express multiple viral antigens. Constructs have shown the ability to elicit both humoral (antibody) and cellular (T-cell) responses with truly exceptional durability without the need for adjuvants.
- Favorable stability and logistics - MVA is stable in both liquid and lyophilized dosage forms, allowing for suitable long-term storage at refrigerator temperatures. MVA can reliably be manufactured in Chicken Embryo Fibroblasts (CEFs) or novel continuous cell lines (e.g.AGE1.CR or DF1 cells) that support scalability as well as greater process consistency and efficiency.
The GeoVax preventive vaccine for HIV (GOVX-B11) has demonstrated outstanding safety, tolerability, and immunogenicity in six prophylactic and therapeutic Phase 1 and 2 trials and is currently being tested with and without a protein boost as a preventive vaccine as well as in multiple therapeutic settings in humans working toward a “functional cure”. The company has also designed, vaccine constructs and analyzed the protective efficacy against numerous emerging infections with epidemic potential. Preclinical studies have been completed for vaccines against Ebola virus and Zika virus, with ongoing preclinical testing in completion for Lassa virus, Marburg virus, Sudan ebola virus, and Malaria. The company is currently in preclinical development for a SARS-CoV-2 vaccine and is in active discussions and negotiations related to additional funding support, as well as securing the necessary manufacturing resources to proceed into clinical development as soon as possible.
Additionally, GeoVax continues to make progress with efforts in cancer immunotherapy. The company is working to move its lead MUC1 candidate into the clinic in 2021. GeoVax is applying the same approach used in constructing its infectious disease vaccines to cancer. The cancer immunotherapy concept is to combine a tumor-associated antigen vaccine with potent anti-tumor agents such as immune checkpoint inhibitors. 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% 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, our MVA-VLP MUC1 vaccine plus a MUC1 peptide provided 100% 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.
Finally, in September 2020, GeoVax secured $12.8 million in funding through a public offering and achieved a listing on the NASDAQ stock market. The Company expects the existing cash resources to sustain operating plans through early 2022. We believe that the strong cash balance and NASDAQ listing support the Company accelerating the development of its vaccine programs in 2021.
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing human vaccines against infectious diseases and cancer using novel patented platforms. GeoVax’s Modified Vaccinia Ankara-Virus Like Particle (MVA-VLP) based vaccine platform utilizes MVA, a large virus capable of carrying several vaccine antigens, that expresses proteins that assemble into VLP immunogens in the person receiving the vaccine. The production of VLP 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.
GeoVax’s MVA-VLP development programs are focused on preventive vaccines against COVID-19, HIV, Zika Virus, and hemorrhagic fever viruses (Ebola, Sudan, Marburg, and Lassa), 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 the National Institutes of Health (NIH). GeoVax’s HIV vaccine is also part of a collaborative effort toward a functional cure for HIV.
Forward-Looking Statements
This release and the related conference call contain forward-looking statements regarding GeoVax’s business plans and financial results. 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 expectations and projections about future events and financial 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 and its collaborators are able to complete their work within the expected timeframes, GeoVax is able to obtain the patent protection sought, GeoVax’s COVID-19 vaccines can provoke responses to multiple COVID-19 antigens, and those vaccines can be used effectively as a primary or booster to other COVID-19 vaccines, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, 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 registration statement on Form S-3 and the periodic reports on Form 10-Q and Form 10-K that we have filed and will file 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. Contact: GeoVax Labs, Inc. investor@geovax.com 678-384-7220
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