Emergent BioSolutions Announces Positive Preclinical Efficacy and PK Data
for Its New Bispecific Adaptir Protein Therapeutic ES414 at AACR
ROCKVILLE, Md. -- April 11, 2013
Emergent BioSolutions Inc. (NYSE: EBS) today announced that two posters on the
development of its lead bispecific ADAPTIR^TM (Modular Protein Technology)
molecule, ES414, were presented earlier this week at the American Association
for Cancer Research annual meeting in Washington, D.C.
The ES414 molecule was constructed using Emergent’s ADAPTIR technology
platform and 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. ES414 is being developed as a potential therapeutic for
castrate-resistant prostate cancer.
In the first poster, Emergent scientists described the efficacy of ES414 to
prevent growth of human prostate cancer cells in vivo that express the PSMA
protein on their surface:
*“Anti-PSMA x anti-CD3 ADAPTIR molecule inhibits tumor growth in vivo”
*Treatment with ES414 showed statistically significant inhibition of
subcutaneous tumor outgrowth in the presence of human T cells in two
independent mouse xenograft models of prostate cancer (C4-2B,
MDA-PCa-2b). In both models, all treatment groups also showed a
statistically significant decrease in serum PSA compared to negative
The second poster described initial PK and tolerability:
*“Pharmacokinetic evaluation and tolerability assessment of anti-PSMA x
anti-CD3 ADAPTIR molecule”
*These non-clinical studies showed that ES414 is pharmacologically
active, has an extended serum half-life compared to antibody
fragments, is well tolerated at levels well above the expected human
dose, and possesses suitable characteristics for further in vivo
“We were excited to present the results of these studies and were very pleased
with the interest these data received at the meeting,” said Jane Gross, Ph.
D., vice president of applied research at Emergent BioSolutions. “ES414 is a
promising molecule. Non-clinical efficacy studies have shown that it is well
tolerated. It can also be manufactured using standard methodologies. These
findings certainly support further development of this molecule and have
generated significant partnering interest in our product candidate.”
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, castrate-resistant prostate cancer.
About the ADAPTIR™ Platform
ADAPTIR bispecific proteins are modular, single chain polypeptides that
comprise two separate binding domains (VL and VH), a hinge segment, and an
effector domain (huFc). They have a differentiated structure from monoclonal
antibodies and can generate a unique signaling response. In addition, ADAPTIR
proteins may mediate complement dependent cytotoxicity and Fc dependent
cytotoxicity, similar to monoclonal antibodies.
ADAPTIR is the new trademark for Emergent BioSolutions Inc.’s modular protein
technologies that were previously identified using the SCORPION^TM
(multispecific protein therapeutic) and SMIP^TM (monospecific protein
therapeutic) trademarks. ADAPTIR and any and all Emergent BioSolutions Inc.
brand, product, service and feature names, logos and slogans are trademarks or
registered trademarks of Emergent BioSolutions Inc. or its subsidiaries in the
United States or other countries. All rights reserved.
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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