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Emergent BioSolutions Presents Preclinical Efficacy Data on ES414 Its Lead ADAPTIR Bispecific Therapeutic for Prostate Cancer

ROCKVILLE, Md.–(BUSINESS WIRE)–May. 3, 2013– Emergent BioSolutions Inc. (NYSE: EBS) today announced that it presented preclinical data on its lead bispecific ADAPTIR^TM (Modular Protein Technology) molecule, ES414, at the 9^th Annual Protein and Antibody Engineering Summit (PEGS), currently underway in Boston, MA. ES414 is being developed as a potential therapeutic for metastatic castration-resistant prostate cancer (mCRPC). Emergent recently presented pharmacokinetic and tolerability results at the American Association for Cancer Research annual meeting in Washington, D.C.

The ES414 molecule selectively binds to the T cell receptor on cytotoxic T cells and Prostate Specific Membrane Antigen (PSMA), an antigen commonly found on prostate cancer cells. In preclinical studies, ES414 has been shown to redirect T-cell cytotoxicity (RTCC) towards prostate cancer cells expressing PSMA.

The poster, “Tolerability Assessment of ES414, an Anti-PSMA x Anti-CD3 ADAPTIR Molecule,” presented results of preclinical studies demonstrating that ES414 is pharmacologically active, well tolerated in toxicology models at levels well above the expected human dose, possesses suitable characteristics for additional in vivo toxicology studies, and merits further investigation as a potential therapeutic for mCRPC treatment.

“The ES414 product candidate is a unique molecule developed from our ADAPTIR technology platform. The preclinical data are encouraging and the molecule has a number of advantages; specifically, activity at very low doses, minimal cytokine release on binding to target and T cells, and a long half-life. Additionally, we have a defined, scalable manufacturing process in place for ES414 to supply future clinical demands. The manufacturing process is fairly standard and is similar to that for making monoclonal antibodies. We look forward to filing an Investigational New Drug application next year,” said W. James Jackson, Ph.D., Chief Scientific Officer at Emergent BioSolutions.

About Prostate Cancer

Prostate cancer is the most common cancer in men with approximately 230,000 new cases annually in the United States. Although screening, radiation, surgery and hormone ablation therapy have greatly improved the detection and treatment of early stage prostate cancer, few options exist to treat metastatic castration-resistant prostate cancer.

About the ADAPTIR™ Platform

ADAPTIR bispecific proteins are modular, single chain polypeptides that comprise two separate binding domains, a hinge segment, and an effector domain (huFc). They have a differentiated structure from monoclonal antibodies and can generate a unique signaling response. Some ADAPTIR molecules, like ES414, may mediate T-cell cytotoxicity by redirecting T cells against tumor cells. In addition, other ADAPTIR proteins may mediate complement dependent cytotoxicity and Fc dependent cytotoxicity, similar to monoclonal antibodies.

About Emergent BioSolutions

Emergent BioSolutions is a specialty pharmaceutical company seeking to protect and enhance life by offering specialized products to healthcare providers and governments to address medical needs and emerging health threats. Additional information may be found at www.emergentbiosolutions.com. Follow us on twitter: @emergentbiosolu.

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, are forward-looking statements. Forward-looking statements in this press release include statements about the potential and therapeutic opportunity of the ADAPTIR molecule. These forward-looking statements are based on our current intentions, beliefs and expectations regarding future events. We cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, we do not undertake to update any forward-looking statement to reflect new information, events or circumstances.

There are a number of 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 our ongoing and planned preclinical studies and clinical trials; the rate and degree of market acceptance and clinical utility of our products; the timing of and our ability to obtain and maintain regulatory approvals for our product candidates; and our commercialization, marketing and manufacturing capabilities and strategy. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in our periodic reports filed with the SEC, when evaluating our forward-looking statements.

 

Source: Emergent BioSolutions Inc.