Tag Archives: Jane Gross

Emergent BioSolutions Presents Efficacy Data on ES210; a Bispecific ADAPTIR Molecule for Treating Au

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Emergent BioSolutions Presents Efficacy Data on ES210; a Bispecific ADAPTIR Molecule for Treating Autoimmune Diseases

ROCKVILLE, Md.–(BUSINESS WIRE)– Emergent BioSolutions Inc. (NYS: EBS) announced today that it has presented data on ES210, one of its bispecific ADAPTIRTM (Modular Protein Technology) molecules, that is targeting autoimmune disease at Keystone Symposia’s Advances in the Knowledge and Treatment of Autoimmunity in Whistler, British Columbia, Canada.

The ES210 molecule was engineered using Emergent’s ADAPTIR technology platform and contains binding sites specific for CD86 coupled to a monomeric form of IL-10 known to confer immunosuppressive activity.

The poster, entitled A Bispecific ADAPTIRâ„¢ Molecule That Targets CD86 and Delivers IL-10 Inhibits Antigen Presenting Cells and Has Potential as a Therapeutic Treatment of Autoimmune Disease,”presentedpre-clinical data showing that ES210 displays high levels of in vitro and in vivo potency in blocking T-cell proliferation in human mixed lymphocyte reactions and in a humanized graft-versus-host disease model. Dendritic cells play a central role in the generation and regulation of immunity; therefore, targeting dendritic cell function represents a therapeutic opportunity to suppress immunopathological processes in autoimmune disease.

“Emergent is investigating an ADAPTIR molecule that targets and blocks the co-stimulatory receptor CD86, while delivering the immunosuppressive cytokine IL-10 to CD86-expressing antigen presenting cells,” said Jane Gross, Ph.D., vice president of applied research at Emergent BioSolutions. “We are pleased to present the study results, which show the ADAPTIR molecule as having potential applications in the treatment of transplant rejection as well as autoimmune and inflammatory diseases such as Crohn’s disease, ulcerative colitis, and rheumatoid arthritis.”

About the ADAPTIRâ„¢ 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

From: http://www.dailyfinance.com/2013/04/11/emergent-biosolutions-presents-efficacy-data-on-es/

Emergent BioSolutions Announces Positive Preclinical Efficacy and PK Data for Its New Bispecific Ada

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Emergent BioSolutions Announces Positive Preclinical Efficacy and PK Data for Its New Bispecific Adaptir Protein Therapeutic ES414 at AACR

ROCKVILLE, Md.–(BUSINESS WIRE)– Emergent BioSolutions Inc. (NYS: 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.”

From: http://www.dailyfinance.com/2013/04/11/emergent-biosolutions-announces-positive-preclinic/