GOVX: GeoVax: Entering into HBV Market
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OTC:GOVX
On Jun 6, 2016, GeoVax (GOVX) announced the launch of a program to develop a therapeutic vaccine for treatment of chronic Hepatitis B infections (HBV).
This announcement marks the official entry into the HBV market by the company.
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 is a clear medical need to treat Hepatitis B infections, which affect millions of people around the world. The CDC estimates that between 700,000 to 1.4 million people in the United States have chronic Hepatitis B virus infections, with an estimated 20,000 new infections every year. Many people are unaware that they are infected or may not show any symptoms. Globally, chronic Hepatitis B affects more than 350 million people and contributes to nearly 800,000 deaths worldwide each year.
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.
GeoVax Ebola Vaccine Protects Non-Human Primates against Lethal Challenge
On June 1, 2016, GeoVax announced that testing of its Ebola vaccine in non-human primates showed 100% protection against a lethal Ebola virus challenge.
In this study, the Ebola vaccine was administered as either a single inoculation (prime) or as two inoculations at a four week interval (prime-boost) to groups of four rhesus macaques each. A control group received the MVA vector without Ebola virus protein inserts. Four weeks after inoculation, animals in all three groups were exposed to a lethal dose of Ebola virus. Three of the four unvaccinated animals died within 12 days, while all of the vaccinated animals survived.
In early September 2015, GeoVax announced positive animal data from its Ebola vaccine
candidate, GOVX-E301, in rodent models. GOVX-E301 provided 100 percent protection in guinea pigs and Syrian golden hamsters, two rodent models for Ebolavirus infections. The GOVX-E301 vaccine uses a recombinant modified vaccinia Ankara (MVA) vector to express non-infectious virus-like particles (VLPs) using genetic sequences from the 2014 Ebolavirus outbreak in West Africa.
The non-human primate data are encouraging because it shows that a single dose of MVA-VLP Ebola vaccine is sufficient for protection against a lethal challenge. This is not only important for the control of natural Ebola outbreaks, but also for rapid control of Ebola intentionally released as a bioterrorism agent.
GeoVax’s MVA-VLP vaccine against the Ebola virus is one component of a tetravalent hemorrhagic fever virus vaccine being developed by GeoVax. The other components are Sudan virus (Sudan ebolavirus), Marburg virus, and Lassa virus MVA-VLP vaccines. These vaccines are envisioned as either individual vaccines in epidemic situations or combined as a tetravalent vaccine for the protection of the millions of individuals who live in at-risk areas, travelers, military personnel, healthcare workers, and others.
The company is ready for human clinical trials during 1H17.
