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GOVX: Multiple Progress Made in the Last Two Months

By Grant Zeng, CFA


New CSO Appointed

On December 14, 2016, GeoVax (OTC:GOVX) announced that the company has promoted Farshad Guirakhoo, PhD, to the role of Chief Scientific Officer (CSO), effective January 1, 2017. Dr. Guirakhoo joined GeoVax in 2015 as Senior Vice President of Research and Development. Previous CSO Harriet Robinson, PhD, will continue to hold an instrumental position with GeoVax as Chief Scientific Officer Emeritus.

As Sr. VP of R&D, Farshad has played a critical role in the growth of the company’s vaccine pipeline. In the new role of CSO, Dr. Guirakhoo will lead the scientific advancement of GeoVax’s technology pipeline.

Dr. Farshad Guirakhoo has been a veteran in the biotech industry. Before joining GeoVax in 2015, Dr. Guirakhoo served in senior management and scientific roles within the biotechnology industry with Vaxess Technologies, Hookipa Biotech, Sanofi Pasteur, Acambis, Inc. and OraVax, Inc. He earned his Ph.D. in Virology at the Medical University of Vienna, Vienna, Austria, holds a M.Sc. degree in Genetics and a B.Sc. degree in Biology. He conducted his Post-Doctoral training at the Medical University of Vienna and at the US National Centers for Disease Control and Prevention (CDC), Division of Vector-Borne Infectious Diseases in Fort Collins, CO. In his scientific career, Dr. Guirakhoo has filed over 90 patent applications and is author/co-author of more than 80 peer reviewed publications, including book chapters. He was instrumental in the development and commercialization of the Imojev Japanese encephalitis virus vaccine and the Dengvaxia vaccine for Dengue virus. In 2014, he was named as one of the 50 Most Influential People in Vaccines.

World-class Scientific Advisory Board Established

On Jan 3, 2017, GeoVax announced the formation of its inaugural Scientific Advisory Board (SAB) to provide expert guidance as the company advances its vaccine development for multiple targets including HIV, hemorrhagic fever (Ebola, Sudan, Marburg, Lassa), Zika virus, chronic Hepatitis B, and immuno-oncology. This world-class SAB will provide strategic guidance for multiple vaccine development efforts.

Inaugural members of the SAB include:

Thomas P. Monath, MD, (Chairman).  Dr. Monath currently serves as CSO and COO of BioProtection Systems, a subsidiary of NewLink Genetics Corporation, where he is leading the development of an Ebola virus vaccine in partnership with Merck.

Stanley A. Plotkin, MD.  Dr. Plotkin is Professor Emeritus at the University of Pennsylvania in Philadelphia, PA and Adjunct Professor at the Johns Hopkins University, Baltimore, MD.

Barney S. Graham, MD, PhD.  Dr. Graham is Senior Investigator at the Vaccine Research Center (VRC), NIAID, NIH, Bethesda, MD. Dr. Graham is an immunologist, virologist, and clinical trials physician whose primary interests are viral pathogenesis, immunity, and vaccine development. His work is focused on respiratory syncytial virus (RSV), influenza, coronaviruses, HIV, and other emerging viral diseases.

Scott C. Weaver, PhD.  Dr. Weaver is Director of the University of Texas Medical Branch (UTMB) Institute for Human Infections and Immunity and the Scientific Director of the Galveston National Laboratory. Dr. Weaver, an internationally recognized virologist and vector biologist, studies arthropod-borne viruses (arboviruses), their transmission by mosquitoes, and develops vaccines to control the diseases that they cause.

Olivera (Olja) J. Finn, PhD.  Dr. Finn is University of Pittsburgh Distinguished Professor of Immunology and Surgery and Founding Chair of the Department of Immunology, a position she held from 2001 to 2013.

Collaboration with Burnet Institute to Expand to Malaria Vaccine

In early Jan 2017, GeoVax entered into a research collaboration agreement with the Burnet Institute for the development of a vaccine to prevent malaria infection.

The Burnet Institute is a leading infectious diseases research institute in Australia.

The project will include the design, construction, and characterization of multiple malaria vaccine candidates using GeoVax’s MVA-VLP vaccine platform combined with malaria Plasmodium falciparum and Plasmodium vivax sequences identified by the Burnet Institute. The vaccine design, construction, and characterization will be performed at GeoVax with further characterization and immunogenicity studies in mice and rabbits conducted at Burnet Institute using their unique functional assays that provide key information on vaccine efficacy.

A first generation infection-blocking malaria vaccine RTS, S/AS01 (Mosquirix) is a recombinant protein-based malaria vaccine, which was approved by European regulators in July 2015. It requires 4 doses and has been recommended by the WHO for pilot implementation studies. Since this vaccine is based on a single antigen and has modest efficacy (30-40%, depending on the age of subjects), the WHO has defined a Road Map for developing and licensing of next generation malaria vaccines. These vaccines are expected to contain multiple antigens designed to block both infection and transmission of malaria with at least a 75% efficacy rate.

In multiple clinical trials, GeoVax’s MVA-VLP-HIV vaccine (producing VLPs in vaccinated subjects) induces a Th1 biased immune response with both durable functional antibodies (IgG1 and IgG3) and CD4+ and CD8+ T cell responses, both of which are hallmarks of an ideal malaria vaccine required for killing intracellular parasites. GeoVax’s proprietary MVA-VLP platform will be used to elicit high titer, durable antibody, and cellular responses to Burnet antigens selected to block both infection and transmission phases of the parasite.

GeoVax to Collaborate with Georgia State University On Development of Therapeutic Hepatitis B Vaccine

In mid-Jan, 2017, GeoVax entered into a research collaboration agreement with Georgia State University Research Foundation (GSU) to advance the development of a therapeutic vaccine for treatment of chronic Hepatitis B Virus (HBV) infections.

The project will include the design, construction, characterization and animal testing of multiple vaccine candidates using GeoVax’s MVA-VLP vaccine platform. Vaccine antigens include both GeoVax and GSU’s proprietary designed sequences. The vaccine design, construction, and characterization will be performed at GeoVax with further characterization and immunogenicity studies in mice conducted at GSU in collaboration with the Shenzhen Graduate School of Peking University. Unique functional assays developed by Dr. Ming Luo, Professor in the Department of Chemistry at Georgia State University, and performed at Peking University will provide key information on vaccine efficacy.

The GeoVax HBV vaccine will be based on the Company’s novel Modified Vaccinia Ankara (MVA) Virus-Like Particle (VLP) platform (MVA-VLP), which generates noninfectious VLPs in the individual being vaccinated. VLPs mimic a natural infection, triggering the body to produce a robust and durable immune response with both antibodies and T cells. The GeoVax MVA-VLP platform has already demonstrated outstanding safety in four clinical trials for the Company’s HIV vaccine candidates, which included 500 participants.

Hepatitis B is a contagious liver disease caused by the Hepatitis B virus (HBV). For some people, Hepatitis B is an acute -- or short-term -- illness; but for others, it can become a long-term, chronic infection that may lead to cirrhosis or liver cancer.

There are multiple preventive vaccines on the market to protect against Hepatitis B infection, but they cannot help patients already diagnosed with the disease. Although chronic Hepatitis B infections can be treated with drugs, less than 5% of chronic Hepatitis B infections are cured. These drugs only suppress the replication of the virus. Therefore, most people who start treatments must continue with them for life. Moreover, diagnosis and treatment options are very limited in resource/low income-constrained populations, which leads to a majority of patients succumbing within months of diagnosis.

Over the years, GeoVax has gained significant experience in developing therapeutic vaccines for infectious diseases including HIV and other viruses. The company’s MVA-VLP technology is well-suited for the development of a therapeutic vaccine against the Hepatitis B virus.

We believe GeoVax’s approach to vaccine design and method of treatment has significant merit. The company’s strategy is to use its therapeutic vaccine in combination with the standard-of-care treatment to reduce the duration of drug therapy, side effects, and potential drug resistance. The goal is to significantly increase the current cure rate of Hepatitis B infections while reducing the overall treatment costs at the same time.

The entry into the HBV space further demonstrates the broad utility of GeoVax’s MVA-VLP platform and solidifies GeoVax as a leader in the next generation of vaccine developers.

Phase I HIV Human Clinical Trial Initiated

On Jan 23, 2017, GeoVax announced the initiation of the next human clinical trial of GeoVax’s preventive HIV vaccine, GOVX-B11. The Phase I trial (designated HVTN 114) is being conducted by the HIV Vaccine Trials Network (HVTN) and is funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

The trial will enroll up to 100 individuals who participated in the HVTN 205 Phase IIa trial of the GOVX-B11 vaccine (concluded in 2012) and will test the ability of late boosts (additional vaccinations) to increase the antibody responses elicited by the GeoVax vaccine. These “late boosts” will consist of the GeoVax MVA62B vaccine with or without a gp120 protein vaccine. The gp120 protein, AIDSVAX® B/E, supplied by Global Solutions for Infectious Diseases (GSID), is the same protein used to boost immune responses in the partially protective RV144 trial in Thailand, and is being used here to assess the effect of late boosts of GOVX-B11 while newer proteins are cGMP manufactured and safety tested for use with GOVX-B11 in future clinical trials. Eligible participants in HVTN 114 will receive either (a) another MVA62B boost, (b) a combined boost of MVA62B and AIDSVAX® B/E, or (c) AIDSVAX® B/E alone.

GOVX-B11 is being developed for use against the clade B subtype of HIV prevalent in the Americas and Western Europe. GOVX-B11 is a DNA/MVA vaccine that expresses non-infectious virus-like particles (VLPs). Clinical trials for GOVX-B11 have been conducted by the NIH-supported HIV Vaccine Trials Network (HVTN) with funding from the National Institute of Allergy and Infectious Disease (NIAID). The HVTN has tested various doses and combinations of the DNA and MVA vaccines in 500 humans with very encouraging results.


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