Cellectis aanounces EG granted ODD to product candidate UCART22

Cellectis announced that the European Commission, or EC, has granted an Orphan Drug Designation, or ODD, to its product candidate UCART22, for the treatment of Acute Lymphoblastic Leukemia, or ALL. UCART22 is an allogeneic CAR T-cell product candidate targeting CD22 and evaluated in BALLI-01, a Phase 1/2 open-label dose-escalation and dose-expansion study, designed to evaluate the safety, expansion, persistence and clinical activity of UCART22 in patients with relapse/refractory ALL. ALL represents 12% of all leukemia cases, progresses rapidly, and is typically fatal within weeks or months if left untreated1. In 2024, the 10-year prevalence is estimated at 1.9 in 100,000 persons in the European Union. Based on the preliminary clinical data generated with UCART22 in heavily pretreated patients who were relapsed or refractory to approved medicinal products, the European Medicines Agency considered that the significant benefit of UCART22 has been demonstrated.