Emergent BioSolutions Announces Positive Preclinical Efficacy and PK Data for Its New Bispecific Adaptir Protein Therapeutic ES414 at AACR
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:
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“Anti-PSMA x anti-CD3 ADAPTIR molecule inhibits tumor growth in
vivo”
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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 controls.
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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
The second poster described initial PK and tolerability:
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“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 toxicology studies.
“We were excited to present the results of these studies and were very
pleased with the interest these data received at the meeting,” said
About Prostate Cancer
Prostate cancer is the most common cancer in men with approximately
230,000 new cases annually in
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 SCORPIONTM
(multispecific protein therapeutic) and SMIPTM (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
About
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.
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but not all, of the factors that could cause actual results to differ
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consider this cautionary statement, as well as the risk factors
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Source:
Emergent BioSolutions
Investors:
Robert G. Burrows,
301-795-1877
Vice President, Investor Relations
BurrowsR@ebsi.com
Media:
Tracey
Schmitt, 301-795-1800
Vice President, Corporate Communications
SchmittT@ebsi.com