Cellectis Announces First Patient Dosing in Europe with In-house Manufactured UCART22 Product Candidate

(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 candidate UCART22 has been administered for the first time to a patient in France, who has completed the 28-day observation period.

“Our team has been working tirelessly to expand our BALLI-01 clinical trial (evaluating UCART22) in Europe. Having our first patient in France administered our in-house manufactured UCART22 product candidate is a significant step forward for Cellectis,” said Mark Frattini, MD, Ph.D., Medical Director of Cellectis. “By targeting the CD22 antigen, our goal is to offer a new therapeutic alternative to patients with relapsed or refractory B-cell acute lymphoblastic leukemia, including patients who have relapsed or who have failed to respond to directed therapy. against the CD19 antigen.

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 study designed to assess the safety and clinical activity of the product candidate in patients with relapsed or refractory B-cell ALL.

With its own Good Manufacturing Practices (GMP) facilities in Raleigh, North Carolina and Paris, Cellectis has control over its production and lead times. Cellectis believes that its off-the-shelf treatment approach, combined with its ability to manufacture its UCART product candidates in-house, gives it a significant market advantage, and significantly increases the chances of eligible patients being treated without delay.

In December 2022, Cellectis presented updated clinical data from its BALLI-01 study during a live webcast, which supports the administration of UCART22 cells after fludarabine, cyclophosphamide and alemtuzumab (FCA)-based lymphodepletion in patients with relapsed or refractory B-cell ALL.

BALLI-01 is actively recruiting patients with relapsed or refractory B-cell ALL following a lymphodepletion regimen of fludarabine, cyclophosphamide and alemtuzumab (FCA).