REDWOOD CITY, CA – January 5, 2017 – PaxVax announced today its partnership with the National Institutes of Health (NIH) and United States Department of Defense (DoD) on its chikungunya vaccine program. According to the terms of the collaboration, PaxVax has in-licensed the NIH virus-like particle (VLP) vaccine technology for chikungunya with plans to bring the vaccine through full commercialization. NIH has already completed a phase 1 trial, and is currently assessing the vaccine in a phase 2 trial. For the past year, PaxVax has been working to develop a commercial manufacturing process and the necessary release assays. In addition to conducting its own trials, PaxVax will work with the Walter Reed Army Institute of Research (WRAIR)—a DoD biomedical research laboratory—to conduct an additional clinical trial to assess the potential advantages of an alum adjuvant in the vaccine formulation.
“The spread of chikungunya represents a significant unmet public health need. At PaxVax, we are committed to ongoing collaboration with the U.S. government for the development of a vaccine to halt the spread of this debilitating infectious disease,” said Nima Farzan, Chief Executive Officer and President. “PaxVax is closely working with partners including NIH and DoD to combat the growing global burden of disease caused by the chikungunya virus.”
The chikungunya virus has caused millions of infections worldwide in the past few years. In late 2013, the first local transmission in the Americas was identified in Caribbean countries and territories. Since then, chikungunya has been identified in 45 countries with more than 1.7 million suspected cases reported to the Pan American Health Organization from affected areas, increasing the incidence of the disease and risk to U.S. travelers.
VLP vaccines are multi-protein structures that mimic the organization and conformation of naturally occurring viruses but lack the viral genome, potentially yielding safer and more inexpensive vaccine candidates. The chikungunya VLP-based vaccine can be efficiently produced in cells growing in bioreactors by self-assembly of viral proteins, an innovative approach for this group of viruses that was pioneered by scientists at NIH’s Vaccine Research Center.
“There is no licensed vaccine to prevent chikungunya and there is no specific treatment for the complications of infection, which are often persistent and debilitating,” said Colonel Paul B. Keiser, Director of the Viral Diseases Branch at WRAIR. “We look forward to working with industry partners to help advance the development of a much needed vaccine.”
The results of NIH’s phase 1 trial were published in The Lancet in 2014, and demonstrated that the vaccine was very well tolerated and highly immunogenic. Results from an ongoing phase 2 trial are expected in the first quarter of 2017.
Chikungunya virus (CHIKV) is an arthropod-borne virus (arbovirus), closely related to other viruses in Africa, South America and Australia that cause similar symptoms. CHIKV is a small, spherical RNA virus and a member of the Alphavirus genus in the family Togaviridae. The virus is vectored by the daytime-biting Aedes aegypti mosquito, which also transmits yellow fever, Zika and dengue viruses. It originated in sub-Saharan Africa, but has variants that spread throughout tropical areas of the world.
CHIKV can also be transmitted by Aedes albopictus mosquitoes, a more cold-tolerant mosquito that could result in the spread of chikungunya to more temperate areas of the world. Chikungunya has been reported in over 100 countries and causes an acute febrile disease with headache, muscle pain, and skin rashes, with severe, often debilitating joint pain in infected patients that can persist for years, especially in adults. Individuals who are at higher risk for more serious complications include infants, the elderly and individuals with chronic medical conditions. There are no antiviral drugs effective against CHIKV, and non-vaccine interventions to prevent infection are limited to using insect repellent, wearing long sleeves and pants, and otherwise restricting exposure to vector mosquitos.
PaxVax develops, manufactures and commercializes innovative specialty vaccines against existing and emerging infectious diseases. PaxVax has commercial vaccines for typhoid fever (Vivotif®) and cholera (Vaxchora™), and vaccines at various stages of preclinical and clinical development for adenovirus, anthrax, chikungunya, hepatitis A, HIV and Zika. PaxVax is focused on traditionally overlooked markets, such as travel, and as part of its social mission, PaxVax is also working to make its vaccines available to broader populations most affected by these diseases. PaxVax is headquartered in Redwood City, California and maintains research and development and Good Manufacturing Practice (GMP) facilities in San Diego, California and Bern, Switzerland and other operations in Bermuda and Europe. More information is available at http://www.PaxVax.com.