Wednesday, November 22, 2017

Targeting chronic hepatitis B infections affecting more than 240 million people worldwide

GeoVax Labs, Inc. (OTCQB: GOVX), a biotechnology company developing human vaccines, announced today (January 17) that it has entered into a research collaboration agreement with Georgia State University Research Foundation (GSU) to advance the Company’s 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.

Therapeutic vaccine candidates will be based upon GeoVax’s novel MVA-VLP vector platform, which has been proven safe in multiple human clinical trials of company’s preventive HIV vaccine. This platform is also being used by GeoVax to develop preventive vaccines against Zika virus and hemorrhagic fever viruses (Ebola, Sudan, Marburg, and Lassa). GeoVax also recently initiated a collaborative project with The Burnet Institute to use its MVA-VLP platform to develop a vaccine to prevent malaria infection.

Farshad Guirakhoo, PhD, GeoVax’s Chief Scientific Officer, stated, “We are fortunate to have the collaboration with nearby Georgia State University and Dr. Ming Luo. The combined efforts and already defined functional assays will serve to rapidly test this innovative concept. There is a clear medical need to treat chronic HBV infections, which affect hundreds of millions of people around the world, many of whom die due to complications of HBV including cirrhosis and cancer. Multiple vaccines exist to protect against HBV infection, but they cannot help patients already diagnosed with the disease. Although chronic HBV can be treated with drugs, the treatments do not cure 95% of patients; they cannot induce strong neutralizing antibodies and cellular responses needed to break tolerance to HBV antigens and clear infections, but 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 many patients succumbing within months of diagnosis. Our strategy is to use our multi-antigen therapeutic vaccine in combination with the standard-of-care treatment to induce functional antibodies and CD4+, CD8+ T cell responses to clear infection and potentially break tolerance. Our goal is to significantly increase the current cure rate of HBV infections while reducing the duration of drug therapy, overall treatment costs, side effects, and potential drug resistance.

Dr. Luo commented, “My team’s efforts continue to unveil the molecular mechanism of immune responses to HBV infection and we are excited to partner with GeoVax to further the development of a HBV therapeutic vaccine. By joining forces with GeoVax, we will apply our highly complementary sets of expertise in an effort to address the problem.”

About Hepatitis B Virus

Hepatitis B is a contagious liver disease caused by the HBV. It is transmitted person-to-person by blood, semen, or other bodily fluids. This can happen through sexual contact, needle sharing, or mother to infant transmission during birth. 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 serious health issues like cirrhosis or liver cancer.

The risk of chronic infection is related to age at infection. Approximately 90% of infected infants will develop chronic infections. As a child gets older, the risk decreases. Approximately 25%–50% of children infected between the ages of 1 and 5 years will develop chronic hepatitis. The risk drops to 6%–10% when a person is infected at over 5 years of age. Worldwide, most people with chronic Hepatitis B were infected at birth or during early childhood.

The CDC estimates that between 700,000 to 1.4 million people in the United States have chronic HBV infections, with an estimated 20,000 new infections every year. Many people are unaware that they are infected or may not show any symptoms. Therefore, they never seek the attention of medical or public health officials. Globally, chronic Hepatitis B affects more than 240 million people and contributes to nearly 686,000 deaths worldwide each year. Even though a preventive HBV vaccine is available, less than 5% of chronic HBV infections are cured.

About GeoVax

GeoVax Labs, Inc., is a clinical-stage biotechnology company developing human vaccines against infectious diseases using its Modified Vaccinia Ankara-Virus Like Particle (MVA-VLP) vaccine platform. The Company’s development programs are focused on vaccines against HIV, Zika, hemorrhagic fever viruses (Ebola, Sudan, Marburg, and Lassa) and malaria. GeoVax recently began programs to evaluate the use of its MVA-VLP platform in cancer immunotherapy and for therapeutic use in chronic HBV infections. GeoVax’s vaccine platform supports in vivo production of non-infectious VLPs from the cells of the very person receiving the vaccine, mimicking a natural infection, stimulating both the humoral and cellular arms of the immune system to recognize, prevent, and control the target infection. For more information, visit www.geovax.com.

Forward-Looking Statements

Certain statements in this document are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act. These statements are based on management’s current expectations and are subject to uncertainty and changes in circumstances. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: 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, and other factors, over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements, and does not intend to do so. More information about these factors is contained in GeoVax’s filings with the Securities and Exchange Commission including those set forth at “Risk Factors” in GeoVax’s Form 10-K.

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