Emergent BioSolutions Presents Preclinical Efficacy Data on ES414 Its Lead
ADAPTIR Bispecific Therapeutic for Prostate Cancer
ROCKVILLE, Md. -- May 03, 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
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
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
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.
Robert G. Burrows, 301-795-1877
Vice President, Investor Relations
Tracey Schmitt, 301-795-1800
Vice President, Corporate Communications
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