Date: 2016-09-19
Type of information: Production agreement
Compound: SPEAR® (Specific Peptide Enhanced Affinity Receptor) T-cell products
Company: Adaptimmune (UK) PCT, a Caladrius Company (USA - CA)
Therapeutic area: Cancer - Oncology
Type agreement: production manufacturing
Action mechanism: cell therapy/gene therapy/immunotherapy product. Adaptimmune's T-cell therapy targets the New York esophageal antigen-1 (NY-ESO) peptide which is present across multiple cancer types. The NY-ESO TCR therapeutic candidate is developed in partnership with GSK. In the U.S. Adaptimmune is conducting multiple Phase 1/2 clinical trials for this NY-ESO TCR therapeutic candidate in patients with solid tumors and hematological malignancies including synovial sarcoma, multiple myeloma, melanoma and ovarian cancer.
Disease:
Details: * On September 19, 2016, Caladrius Biosciences, a cell therapy company combining an industry-leading development and manufacturing services provider announced a new five-year strategic manufacturing services agreement under which PCT will produce SPEAR® T-cell therapies for Adaptimmune Therapeutics. PCT, through dedicated, specialized staff and facilities, will produce the SPEAR® T-cell products at its Allendale, New Jersey facility in a manner compliant with both FDA and European Medicines Agency (EMA) regulations. PCT’s relationship with Adaptimmune is intended to provide Adaptimmune with operational flexibility for the manufacture of its SPEAR T-cell products from development through clinical manufacturing and, ultimately, subject to marketing authorizations, into commercialization.
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