Design of a Universal SARS - CoV2 Vaccine Effective Against Variants

COVID-19 Vaccine Data at the European Society of Medicine (ESMED) General Assembly on August 19, 2021

Key Takeaways

  • The effectiveness of first generation vaccines against new SARS-CoV-2 variants and future coronavirus spillover events remains in question.
  • GeoVax’s universal SARS-CoV-2 vaccine, GEO-CM02 encodes the Spike (S), Membrane (M) and Envelope (E) proteins.
  • A critical and significant opportunity exists for a pan-coronavirus vaccine with the attributes the GV-MVA-VLP™ technology can offer.

Press Release: ATLANTA, GA, August 19, 2021 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company specializing in developing human vaccines and cancer immunotherapies, today presented data from ongoing studies of its preventive vaccine against COVID-19. The presentation titled, “Design of a Universal SARS-CoV-2 Vaccine Against Evolving Variants,” was delivered virtually by Mark J. Newman, Ph.D., GeoVax’s Chief Scientific Officer, during the European Society of Medicine (ESMED) General Assembly, being held August 19-21 in Berlin, Germany.

 First-generation SARS-CoV-2 vaccines were rapidly developed and have proven highly efficacious in the human population and were designed to encode the prefusion stabilized Spike protein (S) with the goal of inducing high levels of neutralizing antibodies. However, potential limitations of narrowly focusing on S are becoming apparent with emerging variants that partially escape neutralization by vaccine induced antibodies. Thus, the effectiveness of these vaccines against new SARS-CoV-2 variants and future coronavirus spillover events remains in question. 

 Using its novel Modified Virus Ankara - Virus Like Particle (GV-MVA-VLPTM) platform, GeoVax has developed a design strategy for vaccines expected to induce broader immunity through inclusion of multiple structural and nonstructural proteins from the target pathogen. The GV-MVA-VLPTM platform is known to elicit a balanced humoral (antibody) and cellular response against a range of immunogens, possibly making immune escape against emerging variants less likely. Expression of the SARS-CoV-2 spike, membrane and envelope proteins by MVA supports the in vivo formation of virus like particles, or VLPs, which induce both antibody and T-cell responses. Incorporation of sequence-conserved nonstructural proteins can provide targets for T-cell responses to increase the breadth and function of vaccine-induced immune responses. This strategy provides the basis for generating a universal vaccine with augmented potential to alleviate the burden of disease caused by circulating coronaviruses.

 In his talk, Dr. Newman discussed GeoVax’s vaccine design strategy for developing a universal SARS-CoV-2 vaccine and presented stability and protein expression data for the Company’s initial vaccine candidate, GEO-CM02, which encodes the Spike (S), Membrane (M) and Envelope (E) proteins. Dr. Newman also presented vaccine efficacy and immunogenicity data for GEO-CM02 from hamster and transgenic mice studies to date.

Dr. Newman’s presentation is available on GeoVax’s website at www.geovax.com/investors/events.

 Dr. Newman commented, “Our studies to date support the use of MVA as a vector for the design and production of next-generation vaccines encoding multiple coronavirus proteins, using the S protein as the antibody target and the M and E proteins as T-cell targets. The combination of S, M and E protein expression supports VLP formation and optimal immunogenicity. In our studies, we observed the induction of functional antibodies and T-cell responses that mediate protection from infection and pathogenesis.”

 David Dodd, GeoVax President and CEO, further commented, “The presentation of data from this study further validates our platform and approach to addressing COVID-19 and its variants. Our vaccines under development are intended to be used as either a primary vaccine or to boost other COVID-19 vaccines as part of vaccination strategies to provide immunity to a range of coronavirus variants. We believe a critical and significant opportunity exists for a pan-coronavirus vaccine with the attributes the GV-MVA-VLPTM technology can offer.”



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

  • The effectiveness of first generation vaccines against new SARS-CoV-2 variants and future coronavirus spillover events remains in question.
  • GeoVax’s universal SARS-CoV-2 vaccine, GEO-CM02 encodes the Spike (S), Membrane (M) and Envelope (E) proteins.
  • A critical and significant opportunity exists for a pan-coronavirus vaccine with the attributes the GV-MVA-VLP™ technology can offer.

Media Gallery

Files

Video Gallery

Design of a Universal SARS - CoV2 Vaccine Effective Against Variants — COVID-19 Vaccine Data at the European Society of Medicine (ESMED) General Assembly on August 19, 2021
View on Youtube

Quotes

Our studies to date support the use of MVA as a vector for the design and production of next-generation vaccines encoding multiple coronavirus prot...
Mark J. Newman, Ph.D.GeoVax’s Chief Scientific Officer
The presentation of data from this study further validates our platform and approach to addressing COVID-19 and its variants. Our vaccines under de...
David DoddGeoVax President and CEO

Related Bios

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.
View Full Bio>>
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.
View Full Bio>>
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.
View Full Bio>>

Contacts

Mark W. Reynolds
investor@geovax.com
678-384-7220