jCyte Outlines Plans to Start Trial of jCell® for Retinitis Pigmentosa
The Center for Breakthrough Medicines (CBM), a contract development and manufacturing organization (CDMO) dedicated to addressing the requirements associated with commercializing cell and gene therapies, and jCyte, a clinical-stage biotech focused on preserving and restoring vision in patients with retinitis pigmentosa (RP) and other retinal degenerative diseases, entered a multi-year manufacturing agreement wherein CBM will be the primary manufacturer of jCyte's U.S. FDA’s Regenerative Medicine Advanced Therapy (RMAT) designated cell therapy, jCell. CBM will provide Phase 3 clinical trial supplies and commercial drug product following Biologics License Application (BLA) approval of jCyte's proprietary jCell platform technology. CBM will also provide all BLA-enabling Chemistry, Manufacturing and Controls (CMC) work to support the program through regulatory approval and commercialization.
KING OF PRUSSIA, Pa., Sept. 20, 2022 /PRNewswire/ -- The Center for Breakthrough Medicines (CBM), a contract development and manufacturing organization (CDMO) dedicated to addressing the unique requirements associated with commercializing cell and gene therapies, and jCyte, a clinical-stage biotech company focused on preserving and restoring vision in patients with retinitis pigmentosa (RP) and other retinal degenerative diseases, today announced a multi-year manufacturing agreement wherein CBM will be the primary manufacturer of jCyte's U.S. Food & Drug Administration's Regenerative Medicine Advanced Therapy (RMAT) designated cell therapy, jCell. Under the terms of the agreement, CBM will provide Phase 3 clinical trial supplies and commercial drug product following Biologics License Application (BLA) approval of jCyte's proprietary jCell platform technology. CBM will also provide all BLA-enabling Chemistry, Manufacturing and Controls (CMC) work to support the program through regulatory approval and commercialization.
NEWPORT BEACH, Calif.--(BUSINESS WIRE)--jCyte, Inc., a private biotechnology company dedicated to improving the lives of patients with retinal degenerative diseases, announced the expansion of the company’s leadership team with the appointment of Dr. Stewart Craig as Chief Technology Officer. In his new role, Dr. Craig will be the strategic and technical lead for all drug product development activities, including manufacturing process development, GMP facility design, build-out and scale-up, technology transfer, analytical test method development, quality control, drug product formulation development, and CMC regulatory interactions and filings.
NEWPORT BEACH, Calif.--(BUSINESS WIRE)--jCyte, Inc., a private biotechnology company dedicated to improving the lives of patients with retinal degenerative diseases, today announced the expansion of the role of Dr. Samir Mody. In addition to his Chief Commercial Officer responsibilities focused on preparing for the North American launch of jCell, Dr. Mody will now also assume leadership for the Global Pricing, Health Economics, and Reimbursement functions for jCyte.
NEWPORT BEACH, Calif.--(BUSINESS WIRE)--jCyte, Inc., a private biotechnology company dedicated to improving the lives of patients with retinal degenerative diseases, announced the expansion of the company’s leadership team with the appointment of R. Heath Coats as Vice President of CMC, Regulatory Compliance and Quality Control. In his new role, Mr. Coats will be the strategic and technical lead for manufacturing design, technology transfer, analytical test development, quality control, drug product formulation development, facility buildout, and CMC regulatory interactions and filings for jCyte’s first-in-class regenerative cell therapy, jCell, for retinitis pigmentosa (RP) and future indications.
-jCyte, Inc., a private biotechnology company dedicated to improving the lives of patients with retinal degenerative diseases, announced the continued expansion of the Company’s leadership team with the appointment of Victor Chao as Vice President of Chemistry, Manufacturing and Controls (CMC) Operations.
NEWPORT BEACH, Calif.--(BUSINESS WIRE)--jCyte Inc., a biotech company dedicated to preserving and restoring vision in patients with retinitis pigmentosa (RP) and other degenerative retinal disorders, announced today podium and poster presentations at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting, held May 1-7, 2021.
NEWPORT BEACH, Calif.--(BUSINESS WIRE)--jCyte Inc., a biotech company dedicated to preserving and restoring vision in patients with retinitis pigmentosa and other degenerative retinal disorders, announced today that results from the Phase 2b clinical trial of jCell in retinitis pigmentosa will be presented at the American Society of Retina Specialists (ASRS) 2020 Virtual Annual Meeting, held July 24-26, 2020.