Clinical-stage biotechnology company Cellectis (Euronext Growth Paris:ALCLS) (NASDAQ:CLLS) announced on Thursday that the US Food and Drug Administration (FDA) has granted Orphan Drug and Rare Pediatric Disease Designation for its UCART22 product candidate targeting Acute Lymphoblastic Leukemia (ALL).
ALL, representing 10% of US leukemia cases, progresses rapidly and is typically fatal within weeks or months if left untreated. UCART22 aims to address an urgent need for new therapies for ALL patients who are ineligible for or relapsing after standard treatments.
These FDA designations mark a significant step towards developing allogeneic CAR T products that would be readily available for all patients.
Cellectis expects to provide study updates by the end of the year.
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