What Differentiates the four GeoVax Covid-19 Vaccines from DNA and RNA focused products.--The CSO Perspective.

Details from the Quarterly Conference Call with Chief Scientific Officer, Mark Newman

Key Takeaways

  • High efficacy, single-dose administration, extensive safety, durability, and minimal refrigeration are where we believe the GeoVax approach makes a meaningful difference.
  • The initial COVID-19 vaccines are primarily focused on vaccine technologies that are largely unproven.
  • The GeoVax approach enables the insertion of multiple antigen fragments, potentially allowing for broader spectrum immunity.

The execution of the Patent and Biological Materials License Agreement with the NIH illustrates our confidence in the MVA-VLP platform. This viral vector provides a level of flexibility to our research efforts that will allow for the design of vaccines that are unique to the marketplace and which can address multiple unmet medical needs. I want to highlight specifically what GeoVax is doing with respect to COVID-19. Our response to this pandemic has resulted in the design of several experimental vaccine candidates that will induce both antibody and cellular immune responses following a single dose. These are being tested in animal models with the plan of selecting the lead candidate early in 2021 for human clinical testing. 

The GeoVax approach enables the design of MVA-vectored vaccines encoding multiple COVID-19 proteins to support the formation of virus-like particles, termed VLP, within the cells of the vaccinated individual. These VLP accurately mimic the virus in structure and as such, will induce optimal immune responses but they are not infectious nor can they cause disease. As a result, we anticipate stronger and broader immune responses will be induced, ideally with a single vaccine dose. In addition to vaccine potency, the induction of a broader immune response involving both antibody and cellular mechanisms should provide an added level of protection against variants of COVID-19 that may arise as the virus continues to circulate globally. 

MVA has a very well documented safety record and its use is approved in multiple countries as a smallpox vaccine in individuals with medical conditions requiring additional safety considerations, such as comprised immune systems associated with cancer treatment, transplantation and even advanced age. Use of MVA as a vaccine vector provides opportunities to tailor vaccines for different markets and address specific niches that otherwise are underserved.  

Info-graphic highlighting the MVA-VLP platform...








About GeoVax
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

For more information, please visit www.geovax.com or follow us on Twitter at @Geovax_News and LinkedIn. 

Key Takeaways

  • High efficacy, single-dose administration, extensive safety, durability, and minimal refrigeration are where we believe the GeoVax approach makes a meaningful difference.
  • The initial COVID-19 vaccines are primarily focused on vaccine technologies that are largely unproven.
  • The GeoVax approach enables the insertion of multiple antigen fragments, potentially allowing for broader spectrum immunity.
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Files

A Single Dose of Modified Vaccinia Ankara Expressing Lassa Virus-like Particles Protects Mice from Lethal Intra-cerebral Virus Challenge
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Modified vaccinia Ankara vaccine expressing Marburg virus-like particles protects guinea pigs from lethal Marburg virus infection
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Related Bios

David A. Dodd
Chairman, President & CEO
Mr. Dodd joined the GeoVax Board of Directors in March 2010 and was elected Chairman in January 2011. His executive management experience in the pharmaceutical and biotechnology industries spans more than 40 years. From September 2017 to June 2018, Mr. Dodd served as CEO, and as a member of the Board of Directors, of Medizone International, Inc., a medical device manufacturer. From April 2013 to July 2017, Mr. Dodd served as President and CEO, and as a member of the Board of Directors, of Aeterna Zentaris Inc., a drug development company. He was Chairman of the Board of Directors of Aeterna Zentaris, Inc. from May 2014 to May 2016, and continued to serve as a member of its Board of Directors until May 2018. From December 2007 to June 2009, Mr. Dodd was President, CEO and Chairman of BioReliance Corporation, a leading provider of biological safety and related testing services. From October 2006 to April 2009, he served as non-executive Chairman of Stem Cell Sciences Plc., where he oversaw the development and implementation of a strategic growth plan, implementation of an experienced executive team, and the sale of the company to Stem Cells, Inc. in April 2009. He is also the CEO of RiversEdge BioVentures, an investment and advisory firm focused on the life sciences and pharmaceuticals industries, which he founded in 2009.

During Mr. Dodd's six-year tenure as President, CEO and Director of Serologicals Corporation, the market value of that company increased from $85 million in June 2000 to an all-cash sale to Millipore Corporation in July 2006 for $1.5 billion. That successful transformation followed his five-year term as President and CEO of Solvay Pharmaceuticals, Inc. and as Chairman of its subsidiary Unimed Pharmaceuticals, Inc. Prior to that, Mr. Dodd held various senior management positions at Wyeth-Ayerst Laboratories, the Mead Johnson Laboratories Division at Bristol-Myers Squibb, and Abbott Laboratories.

He is a frequently invited speaker and panelist at business and economic development conferences, as well as various conferences focused on the life sciences and pharmaceutical industry. He is a recipient of the Oglethorpe Award for UK-US Business Relationships, the Georgia BIO Industry Growth Award, and the FastTech 50 Growth Company Award (2000-2006) while leading Serologicals Corporation.

Mr. Dodd holds Bachelor of Science and Master of Science degrees from Georgia State University and completed the Harvard Business School of Advanced Management Program.
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Mark J. Newman, Ph.D.
Chief Scientific Officer
Dr. Newman has more than 30 years’ experience in the biotechnology sector serving in senior management roles at GeoVax (Atlanta, GA), PaxVax (San Diego, CA), Pharmexa (Horsholm, Denmark), Epimmune (San Diego, CA), Vaxcel (Atlanta, GA), Apollon (Philadelphia, PA) and Cambridge Biotech (Boston, MA) where he directed research, development and early stage clinical testing of protein, peptide, plasmid DNA and viral vectored vaccines and multiple vaccine adjuvants. He participated with or directed teams responsible for the transition of 10 vaccine or vaccine-related products from the research stage to Phase 1 and 2 clinical testing. He also served as the primary scientific director for multiple corporate teams that completed Due Diligence reviews, technology assessments and intellectual property review and portfolio management to support strategic planning, technology in-licensing and out-licensing, corporate partnering and mergers and acquisitions.

Dr. Newman has co-authored more that 100 scientific papers, reviews and book chapters during his professional career. He is a named co-inventor on multiple issued US and PCT patents, all related to vaccine technologies. He served as the Principal Investigator on multiple USA government and foundation grants and contracts and has served as a grant and contract review expert for 20 years for National Institutes of Health.

Dr. Newman is a graduate of the Ohio State University (B.Sc. and M.Sc.) and received his Ph.D. in Immunology from the John Curtin School of Medical Research, the Australian National University (Canberra, Australia). He completed four years post-doctoral training at Cornell University and the Uniformed Services University of Health Sciences under contract with the National Cancer Institute, National Institutes of Health. He also served four years as a full-time member of the Louisiana State University faculty at the School of Veterinary Medicine prior to joining the biotechnology industry in 1989.
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Harriet L. Robinson, Ph.D.
Chief Scientific Officer Emeritus
Dr. Robinson joined the Company as Senior Vice President, Research and Development on a part-time basis in November 2007 and on a full-time basis in February 2008, and was promoted to Chief Scientific Officer in 2010. She was elected to the Board of Directors in June 2008. Dr. Robinson is the developer of GeoVax's HIV/AIDS vaccine technology and is one of the world's leaders in HIV/AIDS vaccine research. She co-founded GeoVax in 2001 to facilitate taking the AIDS vaccine developed in her laboratory at the Emory Vaccine Center in collaboration with scientists at the National Institutes of Health into the clinic.

From 1999 to February 2008, Dr. Robinson served as the Asa Griggs Candler Professor of Microbiology and Immunology at Emory University in Atlanta, Georgia, and from 1998 to February 2008 as Chief, Division of Microbiology and Immunology, Yerkes National Primate Research Center. She was a Professor in the Department of Pathology at the University of Massachusetts Medical Center from 1988 to 1997 and Staff, then Senior, then Principal Scientist at the Worcester Foundation for Experimental Biology from 1977 to 1987. Dr. Robinson received a bachelor of arts degree from Swarthmore College and M.S. and Ph.D. degrees from the Massachusetts Institute of Technology.
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Mark W. Reynolds
Chief Financial Officer
Mr. Reynolds joined GeoVax on a part-time basis in October 2006 as Chief Financial Officer and Corporate Secretary, becoming a full-time employee in January 2010. From 2003 to 2006, before being named Chief Financial Officer of GeoVax, Mr. Reynolds provided financial and accounting services to the Company as an independent contractor. From 2004 to 2008, he served as Chief Financial Officer for HealthWatchSystems, Inc. a privately-held company in the consumer healthcare industry. From 2004 to 2006, he served as Chief Financial Officer for Duska Therapeutics, Inc., a publicly-held biotechnology company. From 1988 to 2002, Mr. Reynolds was first Controller and later Chief Financial Officer of CytRx Corporation, a publicly-held biopharmaceutical company. Mr. Reynolds began his career as an auditor with Arthur Andersen & Co. from 1985 to 1988. He is a certified public accountant and earned a master’s of accountancy degree from the University of Georgia.
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Contacts

Mark W. Reynolds
investor@geovax.com
6783847220