Cellectis Reports Preliminary Results from its Phase 1 BALLI-01 Study of UCART22 in R/R Adult B-ALL at American Society of Hematology (ASH) Annual Meeting

• Cellectis’ Proprietary Program UCART22 was Safely Administered in BALLI-01 Phase 1 Study with No Dose-Limiting Toxicity or Evidence of Graft-Vs-Host Disease

• 2 out of 3 Patients at DL1 Achieved CR/CRi and 1 out of 2 Patients at DL2 Achieved a Significant Reduction in Bone Marrow Blasts
  
  
• BALLI-01 Currently Enrolling at DL2 with Addition of Alemtuzumab to the FC Lymphodepletion Regimen; Next Data Update Expected in 2021

NEW YORK, Dec. 05, 2020 (GLOBE NEWSWIRE) -- Cellectis (Euronext Growth: ALCLS - Nasdaq: CLLS), a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), announced preliminary results from Cellectis’ dose escalation Phase 1 BALLI-01 study of UCART22 product candidate in relapsed/refractory B-cell Acute Lymphoblastic Leukemia (B-ALL) were presented at the American Society of Hematology (ASH) Annual Meeting. This is the first publicly released data from Cellectis’ BALLI-01 clinical trial.

The BALLI-01 clinical trial presentation released at the ASH Annual Meeting is available on the Cellectis website: https://bit.ly/CellectisASH2020

“We are encouraged by the promising preliminary data obtained from the first two lower dose levels of UCART22 following a standard fludarabine and cyclophosphamide lymphodepletion regimen from the BALLI-01 trial. The anti-leukemia activity observed in these patients with B-ALL who had been previously heavily pre-treated speaks to the validity of CD22 as a target in the CAR T-cell space, and demonstrates the promise of allogeneic cellular therapies to leapfrog the autologous CAR-T products. We have now started enrolling cohorts that include alemtuzumab, an anti-CD52 monoclonal antibody, in the lymphodepletion regimen, as we anticipate this may extend the window of persistence of our TALEN gene-edited allogeneic CAR T-cells,” said Carrie Brownstein, MD, Chief Medical Officer, Cellectis. “Based on the strong progress of our partnered- and proprietary product candidate portfolio, which was presented at ASH, we are looking forward to presenting additional clinical data in 2021.”

Characteristics

As of the November 2, 2020 data cutoff, 7 patients were enrolled and 5 patients received UCART22 cells. One patient failed screening and one patient was discontinued prior to the administration of UCART22 cells due to an adverse event related to the lymphodepletion.

Safety

No patient experienced a DLT, ICANS, GvHD, AESI¹, nor UCART22-related Grade ≥3 adverse event (AE) nor serious adverse event (SAE). No patient discontinued treatment due to a UCART22-related treatment-emergent adverse event.