Jaguar8 commented on a stock · Jul 25 15:31

NEWS

FDA Grants Orphan Drug and Rare Pediatric Disease Designation Status to Cellectis’ UCART22 product candidate for Acute Lymphoblastic Leukemia (ALL) Treatment

Cellectis (NASDAQ: CLLS) announced that the FDA has granted Orphan Drug (ODD) and Rare Pediatric Disease Designation (RPDD) Status to its UCART22 product candidate for treating Acute Lymphoblastic Leukemia (ALL).

ALL represents 10% of leukemia cases in the US, progressing rapidly and often fatal if untreated.

The designations highlight UCART22's potential to address urgent needs in ALL treatment, especially for patients ineligible for stem cell transplantation or relapsing after other therapies.

UCART22, an allogeneic CAR T-cell therapy, is being evaluated in the BALLI-01 Phase 1/2 study. Recent data showed a 67% preliminary response rate at Dose Level 2 for UCART22-P2, manufactured by Cellectis.

The company expects to provide updates on BALLI-01 by year-end 2024.

These FDA designations may expedite development and reduce costs for UCART22.

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