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

• UCART22 is currently the most advanced allogeneic CAR T-cell product in development for relapsed or refractory B-cell acute lymphoblastic leukemia
• The BALLI-01 study (evaluating UCART22) is actively enrolling patients with relapsed or refractory B-cell ALL after FCA lymphodepletion

 

New York, NY – April 11, 2023 - Cellectis (the “Company”) (Euronext Growth: ALCLS - NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, today announced that the first patient in Europe has been dosed in France with its in-house manufactured product candidate UCART22 and completed the 28-day Dose Limiting Toxicity period.

“Our team has worked tirelessly to expand our BALLI-01 clinical study (evaluating UCART22) to Europe. Dosing our first patient in France with our UCART22 product candidate manufactured in-house is an important advancement for Cellectis” said Mark Frattini, M.D., Ph.D., Chief Medical Officer at Cellectis. “By targeting the CD22 antigen, we aim at offering   a novel therapeutic alternative to patients living with relapsed/refractory B-cell ALL, including those patients who have relapsed or did not respond to CD19-directed therapy. ”

UCART22 is an allogeneic CAR T-cell product candidate that targets CD22 and is evaluated in the BALLI-01 clinical study, a Phase 1/2a open-label study designed to evaluate the safety and clinical activity of the product candidate in patients with r/r B-cell ALL. UCART22 is currently the most advanced allogeneic CAR T-cell product in development for r/r B-cell ALL.

With its proprietary GMP manufacturing facilities in both Raleigh (North Carolina) and Paris (France), Cellectis has taken full control of UCART production and manufacturing timelines. Cellectis believes that its off-the-shelf treatment approach, coupled with its ability to manufacture UCART product candidates completely in-house, gives the Company a main advantage on the market: it potentially maximizes the chances for eligible patients to be treated without delay.

In December 2022, Cellectis presented positive preliminary clinical data for UCART22 in a Live Webcast, that support the continued administration of UCART22 after fludarabine, cyclophosphamide and alemtuzumab (FCA) lymphodepletion in patients with r/r B-cell ALL. The BALLI-01 study (evaluating UCART22) is actively enrolling patients with r/r B-cell ALL after FCA lymphodepletion. For more information, eligibility criteria and trial locations, please visit www.clinicaltrials.gov (NCT04150497) or contact clinicaltrials@cellectis.com