ROCKVILLE, MD, USA I April 11, 2013 I Emergent BioSolutions Inc. (NYSE: EBS) today announced that two posters on the development of its lead bispecific ADAPTIRTM (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 controls.
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 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 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 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 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 twitter: @emergentbiosolu.
SOURCE: Emergent BioSolutions
Post Views: 242
ROCKVILLE, MD, USA I April 11, 2013 I Emergent BioSolutions Inc. (NYSE: EBS) today announced that two posters on the development of its lead bispecific ADAPTIRTM (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 controls.
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 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 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 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 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 twitter: @emergentbiosolu.
SOURCE: Emergent BioSolutions
Post Views: 242
