(Boursier.com) — Cellectis a clinical-stage biotechnology company that uses its pioneering TALEN genome-editing technology to develop innovative therapies for the treatment of serious diseases, today announces that its in-house manufactured product UCART22 has been administered for the first once to a patient in the United States, who completed the 28-day observation period (DLT), on December 14, 2022, without complications.
“Administering a patient with an in-house manufactured product candidate for the first time is a major milestone for Cellectis. UCART22 offers a potential therapeutic alternative for patients with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL), including patients who have relapsed or failed to respond to therapy directed against the CD19 antigen. Controlling our in-house manufacturing maximizes the chances that eligible patients can be treated without delay,” said Dr. Mark Frattini, MD, Ph. D., medical director of Cellectis.
“This is an important milestone for Cellectis: our in-house manufacturing capabilities would allow us to develop product candidates like UCART22 from research, through development, to a finished UCART product in a timeframe that would not have been possible by working with a contract manufacturer,” said Steven Doares, Senior Vice President, US Manufacturing & Raleigh Site Head. “We believe that controlling our manufacturing in-house is a great competitive advantage, as it allows us to quickly adapt our product candidates based on clinical responses, resulting in what we hope will be the best possible product.”
UCART22 is an allogeneic CAR T product candidate that targets the CD22 antigen and is being evaluated in the BALLI-01 clinical trial, an open-label Phase 1/2a dose escalation study designed to assess safety and clinical activity of the product candidate in patients with relapsed or refractory B-cell ALL.
Three years ago, Cellectis made the decision to build its own Good Manufacturing Practices (GMP) facilities in Raleigh, North Carolina and Paris to take control of its production and manufacturing timelines. Cellectis’ facilities are fully operational and demonstrate the Company’s transformation into an end-to-end cell and gene therapy company, from discovery to product development, transfer to GMP manufacturing, to clinical development.
Cellectis is one of the few allogeneic CAR T cell therapy companies that controls its end-to-end gene and cell therapy process. ?
BALLI-01 is actively recruiting patients with relapsed or refractory B-cell ALL.