• Subjects had a stronger, more rapid immune response when the adjuvant CPG 7909 is combined with BioThrax;
• Company also completes dosing of the last subject in ongoing NuThrax Phase 1b Clinical Trial.
Emergent BioSolutions Inc. announced today that results from a Phase 1a clinical trial evaluating an investigational anthrax vaccine, Anthrax Vaccine Adsorbed with CPG 7909 Adjuvant mixed at bedside, have been published in Vaccine, a leading medical journal on vaccines and immunology.
In the study, which enrolled 69 subjects, the addition of the CPG 7909 adjuvant to BioThrax® (Anthrax Vaccine Adsorbed), the only FDA-licensed anthrax vaccine, accelerated and enhanced the immune response to the vaccine in healthy volunteers. Trial subjects received three doses of either: (1) BioThrax alone, (2) 1 mg of CPG 7909 alone or (3) BioThrax plus 1 mg of CPG 7909, all given intramuscularly on study days 0, 14, and 28. Data from the trial show that BioThrax plus CPG 7909 generated peak antibody responses that were 6-fold higher than those generated by BioThrax alone (232 g/ml with BioThrax alone; 1465 g/ml with BioThrax plus CPG 7909). BioThrax plus CPG 7909 also accelerated the time to reach the peak immune response seen following BioThrax vaccination by three weeks. Both of these findings were statistically significant (P<0.001). Early immune responses are important due to the rapid disease progression of anthrax.
The paper,"Marked enhancement of the immune response to BioThrax by the TLR9 agonist CPG 7909 in healthy volunteers," appears in the August 26 edition of Vaccine.
Emergent has also completed dosing of the last subject in its ongoing Phase 1b clinical trial to evaluate the safety, tolerability, and immunogenicity of different formulations of BioThrax pre-formulated with a novel immunostimulatory oligodeoxynucleotide compound, CPG 7909, also known as AV7909 or NuThraxTM (Anthrax Vaccine Adsorbed with CPG 7909 Adjuvant). The study, which was initiated in December 2010, involves 105 healthy volunteers. The company anticipates preliminary data to be available as early as Q3 2011.
"Emergent is pleased to share this information related to our anthrax vaccine development program," said Daniel J. Abdun-Nabi, president and chief operating officer of Emergent BioSolutions. "The Phase 1a data on BioThrax plus CPG 7909 add support to our hypothesis that the combination could have enhanced characteristics over BioThrax alone. Such characteristics could increase the attractiveness of this product candidate to potentially support the U.S. government's multi-product strategy in stockpiling medical countermeasures."
The Phase 1a study was supported by Defense Advanced Research Projects Administration (DARPA) contract DAAD1903C0002. The ongoing Phase 1b trial for NuThrax is being conducted with support from a development contract that is jointly administered under contract number HHSN272200800051C by the National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health (NIH), and the Office of the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services (HHS).
About Emergent BioSolutions, Inc.
Emergent BioSolutions (emergentbiosolutions.com) protects and enhances life by developing and manufacturing vaccines and therapeutics that are supplied to healthcare providers and purchasers for use in preventing and treating disease. Emergent's marketed and investigational products target infectious diseases, oncology, and autoimmune disorders.
Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, including any potential future securities offering, our expected revenue and net earnings for 2011, and any other statements containing the words "believes","expects","anticipates","plans","estimates" and similar expressions, are forward-looking statements. Such statements are based upon the current beliefs and expectations of management that are subject to risks, uncertainties, and other important factors that could cause the company's actual results to differ materially from those indicated by such forward-looking statements, including the success of preclinical studies and clinical trials, and post-approval clinical utility of our products; our plans to pursue label expansions and improvements for BioThrax®; the rate and degree of market acceptance of our products and product candidates; the success of our ongoing and planned development programs; the timing of and our ability to obtain and maintain regulatory approvals for our product candidates; our commercialization, marketing and manufacturing capabilities and strategy; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other factors identified in the company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2011 and subsequent reports filed with the SEC. The company disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.
Robert G. Burrows, Vice President, Investor Relations
P: 301-795-1877 / E: BurrowsR[.]ebsi.com.