NIAID To Fund Development Of Emergent BioSolutions' Advanced Anthrax Vaccine Candidate

Main Category: Bio-terrorism / Terrorism
Also Included In: Immune System / Vaccines
Article Date: 02 Oct 2009 - 0:00 PDT

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Emergent BioSolutions Inc. (NYSE:EBS) announced that it was awarded a cooperative agreement from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, to further the development of one of Emergent's advanced anthrax vaccine candidates known as dmPA7909. The novel vaccine candidate is designed to have characteristics that will make it ideal to meet the U.S. government's needs for an advanced anthrax vaccine such as the potential to confer a rapid immune response following only two doses, long-term stability to enable ambient storage in the Strategic National Stockpile, and the potential to be distributed in a national emergency without the need for cold chain storage conditions.

"We are excited about receiving NIAID funding support for dmPA7909, one of Emergent's next generation anthrax vaccine candidates in development," said W. James Jackson, Ph. D., senior vice president and chief scientific officer of Emergent BioSolutions. "We look forward to advancing dmPA7909, along with our other vaccine and therapeutic candidates in our anthrax program, as we continue to support the U.S. government's approach of funding the development of multiple medical countermeasures against the threat of bioterrorism."

The anthrax vaccine candidate is composed of the double-mutant recombinant protective antigen (dmPA), which has been genetically engineered for improved stability. dmPA is adsorbed to Alhydrogel®, combined with the immunostimulatory compound CPG 7909 (VaxImmune TM) and formulated as a dry powder. Emergent is employing proven stabilizing technologies for each of the components in the vaccine formulation to seek to maximize vaccine stability even at elevated temperatures and to extend shelf life.

This funding in the amount of $4.9 million over a two-year period provides for manufacturing of clinical lots, non-clinical safety and efficacy studies, and stability studies to demonstrate whether the vaccine candidate can withstand high temperatures up to 37oC.

The cooperative agreement is funded through the American Recovery and Reinvestment Act of 2009 (ARRA), which was signed into law on February 17 to stimulate the growth and recovery of the U.S. economy.

About Emergent's Anthrax Program

Emergent's anthrax program consists of a licensed vaccine and several novel vaccines and immune-related therapeutics in development:

- BioThrax® (Anthrax Vaccine Adsorbed) - the only vaccine licensed by the FDA for the prevention of anthrax infection. Since 1998, the U.S. government has procured nearly 34.5 million doses of BioThrax. During that time period, nearly 8.7 million doses have been administered to more than 2.2 million military personnel.

- rPA Anthrax Vaccine - a recombinant anthrax vaccine candidate, which is composed of a purified protective antigen protein adsorbed to an aluminum adjuvant and is designed to induce antibodies that neutralize anthrax toxins.

- Advanced Anthrax Vaccine (dmPA7909) - a recombinant anthrax vaccine candidate, which is composed of the double-mutant protective antigen, licensed from NIAID, adsorbed to Alhydrogel®, combined with the immunostimulatory compound CPG 7909 (VaxImmuneTM), licensed from Pfizer, Inc., and formulated as a dry powder.

- Advanced Anthrax Vaccine (AV7909) - an anthrax vaccine candidate based on BioThrax combined with the immunostimulatory compound CPG 7909 (VaxImmuneTM), licensed from Pfizer, Inc. We are anticipating this candidate will have advanced characteristics, including one or more of the following: reduced number of doses, enhanced immune response, longer expiry dating or a novel delivery method.

- Anthrax Immune Globulin Therapeutic (AIG) - a polyclonal anthrax immune globulin candidate being developed as an intravenous post-exposure treatment for patients who present with symptoms of anthrax disease. AIG is derived from human plasma from individuals who have been vaccinated with BioThrax.

- Anthrax Monoclonal Antibody Therapeutic - a fully human anthrax monoclonal antibody candidate also being developed as an intravenous post-exposure therapy for individuals who have symptoms of anthrax disease. Based on pre-clinical animal studies, this monoclonal antibody appears to be a highly active therapeutic.

Source
Emergent BioSolutions Inc.