We apply our proprietary BEVS platform technology to produce the next generation of vaccines for the prevention and treatment of a wide range of diseases.
Our lead product candidates are vaccines for protection against seasonal and pandemic influenza. Influenza is a leading cause of illness and death around the world. It results, on average, in more than 200,000 hospitalizations and 3,000 to 49,000 deaths annually in the U.S. alone. New strains of influenza of pandemic potential are continually emerging (e.g., H1N1) and can be associated with high mortality rates (>70%).
An independent market study (Datamonitor, 2007) found that the worldwide influenza vaccine market is growing rapidly and is predicted to more than double in size to more than $4.4 billion by 2016. We have established a broad patent estate on influenza vaccines produced using recombinant technology in our expresSF+ cells.
Flublok Quadrivalent vaccine is the quadrivalent version of FDA-approved trivalent Flublok influenza vaccine and is designed to protect against four strains of influenza - the three strains that are included in trivalent Flublok plus one additional B strain. The vaccine is comprised of purified recombinant hemagglutinin antigens that are manufactured using the same process as is used to make trivalent Flublok. Similar to trivalent Flublok, Flublok Quadrivalent contains 3x more antigen than traditional quadrivalent influenza vaccines.
In a recent clinical study, Flublok Quadrivalent was shown to outperform a traditional quadrivalent influenza vaccine and was better at preventing the flu. The study enrolled approximately 9,000 adults 50 years and older and compared Flublok Quadrivalent to a licensed quadrivalent influenza vaccine made in eggs during the 2014/15 influenza season. The data showed that Flublok recipients were 43% less likely to develop culture confirmed influenza than people who received the traditional vaccine. Click here to learn more.
A supplemental BLA for Flublok Quadrivalent has been submitted to the FDA and approval is expected in 2016.
Our Severe Acute Respiratory Syndrome (SARS) vaccine candidate (D3252) is comprised of purified recombinant Spike protein from the SARS virus. Preclinical studies have shown that immunization with D3252 can elicit neutralizing antibodies to the virus, similar to the effect seen with our vaccines against influenza.
SARS is a respiratory disease caused by a coronavirus that emerged as an infectious agent from an outbreak in 2003. The main symptoms of SARS include fever, cough, shortness of breath and difficulty breathing. In 2004, the World Health Organization reported that SARS was fatal in approximately 10-15% of cases. There are no preventative or treatment options available for SARS.
The vaccine being developed is based on production of recombinant variations of the E protein from the Zika virus. Similar vaccine candidates produced at Protein Sciences against West Nile Virus and Japanese Encephalitis Virus, which are close relatives of the Zika Virus, have previously been shown to neutralize their respective viruses in preclinical studies.
Click on the links below to learn more about influenza and the safety and efficacy of vaccines to prevent infectious diseases.
Centers for Disease Control and Prevention
Families Fighting Flu
National Institute of Allergy and Infectious Diseases
World Health Organization
U.S. Government Reports
President's Council of Advisors on Science and Technology (PCAST)
Influenza Vaccine: Federal Investments in Alternative Technologies and Challenges to Development and Licensure (GAO-11-435)
Influenza Pandemic: Lessons from the H1N1 Pandemic Should be Incorporated in Future Planning (GAO-11-623)