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GeoVax and CaroGen to Collaborate On Development of Therapeutic Hepatitis B Vaccine

Wednesday, February 7, 2018   (0 Comments)
Posted by: Kristen Pappaterra
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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 that it is collaborating with CaroGen Corporation on the development of a combination immunotherapy treatment for chronic hepatitis B virus (HBV) infection.

The project will include testing GeoVax’s MVA-VLP-HBV (Modified Vaccinia Ankara-Virus Like Particle-Hepatitis B Virus) vaccine candidate in combination with CaroGen’s HBV virus-like vesicles (VLVs) vaccine candidate in prophylactic and therapeutic animal models of HBV. Therapeutic experiments may be carried out in combination with anti-viral drugs, TLR agonists, or immune checkpoint inhibitors which are currently in use (or anticipated to be used in future) as part of the standard of care for treatment of this particularly difficult to treat disease. GeoVax’s vaccine candidate is based upon its novel MVA-VLP vector platform, which has been proven safe in multiple human clinical trials of the company’s HIV vaccine. CaroGen’s vaccine candidate employs a transformative VLV platform technology developed at Yale University School of Medicine and exclusively licensed by CaroGen for the development and commercialization of immunotherapies worldwide.

Farshad Guirakhoo, Ph.D., GeoVax’s Chief Scientific Officer, stated, “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 preventive vaccines exist to protect against acquiring HBV infection, but they cannot help patients already diagnosed with the disease. Although HBV infection can be treated with drugs, the treatments cure just 5% of patients and only suppress the replication of the virus in others. 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 to the disease within months of diagnosis.”

Dr. Guirakhoo continued, “We are pleased to begin this collaboration with CaroGen, as it complements our existing collaboration with Georgia State University, increasing our chances of success. Our strategy is to use both vaccines as part of a combination strategy with current or future HBV treatments to induce functional antibodies as well as CD4+, CD8+ T cell responses to break tolerance to HBV antigens and clear the infection. Our ultimate goal is to significantly increase the current cure rate of chronic HBV infection while reducing the duration of drug therapy, overall treatment costs, side effects, and potential drug resistance.”

Valerian Nakaar, Ph.D., Vice President, Research & Development at CaroGen commented, “There is a compelling mechanistic rationale for combining both platform technologies for the treatment of HBV. We are excited to initiate this collaboration because the success accruing from these studies will portend well for other hard-to-treat chronic infections.”

About Hepatitis B

Hepatitis B is a contagious liver disease caused by 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, HBV infection is an acute (short-term) illness, but for others it becomes a chronic (long-term) infection that can lead to serious health issues like cirrhosis or liver cancer.

The risk of chronic HBV 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 a chronic infection. The risk drops to 6–10% when a person is infected at over 5 years of age. Worldwide, most people with chronic HBV are infected at birth, during early childhood or later in life when vaccine-acquired immunity wanes.

The CDC estimates that between 700,000 to 1.4 million people in the United States suffer from 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 HBV affects more than 240 million people and contributes to nearly 686,000 deaths worldwide each year. Currently, there is no FDA approved therapeutic vaccine available and despite more than $4 billion spent annually on anti-viral drugs, 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 MVA-VLP vaccine platforms. The Company’s HIV-1 vaccine for the clade B, the dominant subtype in the Americas, Western Europe and Australia, is advancing in human trials conducted by the HIV Vaccine Trials Network (HVTN). Preclinical programs are focused on preventive vaccines for the clade C HIV (the subtype that is highly prevalent in countries of Southern Africa, as well as in the horn of Africa and India representing nearly 50% of all people living with HIV), Zika virus, hemorrhagic fever viruses (EBOV, SUDV, MARV, and LASV), and malaria, as well as therapeutic vaccines for HIV (aiming for a functional cure), HBV and cancers. 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 and 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.

About CaroGen

CaroGen Corporation is a private biopharmaceutical company focused on developing immunotherapies for chronic viral infections and cancers. CaroGen’s proprietary virus-like vesicle (VLV) platform technology developed at Yale University has been licensed by the company exclusively for the development and commercialization of immunotherapies worldwide for both human and animal use. CaroGen has developed a broad technology platform that is safer and with the potential to deliver multiple targets including antigens, cytokines and shRNAs. For further information, visit www.carogencorp.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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