84% ORR (32 of 38 patients) and 71% CR (27 of 38 patients) documented after 2 million cells/kg dose anbal-cel treatment to patients in relapsed/refractory large B-cell lymphoma Durable complete response was measured-68% at 1 month, 61% at 3 months, and 60% at 6 months respectively.
DAEJEON, South Korea, June 20, 2023 /PRNewswire/ — Curocell Inc, a Korea-based clinical-stage CAR-T cell therapy company, announced updated Phase 2 interim results for Anbalcabtagene-autoleucel (anbal-cel) on June 15, 2023, at ICML (International Conference on Malignant Lymphoma), Lugano, Switzerland.
The anbal-cel is the next-generation OVISTM technology applied to anti-CD19 CAR-T using the 4-1BB domain as a co-stimulation domain as and also it consists of a dual knockdown system for two immune checkpoint receptors, PD-1 and TIGIT, in CAR-T cells.
The Phase 2 study of anbal-cel was conducted to evaluate the efficacy and safety in patients with r/r LBCL. Patients with relapsed or refractory LBCL were enrolled in six Korean investigator sites to receive anbal-cel at a dose of 2×106 CAR-T cells/kg.
41 patients with r/r LBCL were infused with anbal-cel. All patients received two or more prior lines of therapy and 10% (4 of 41) received ≥4 prior lines of treatment before the study.
84% ORR (32/38), 71% CR (27/38) were reached, and durable complete response was monitored as CR at 1 month was 68% (26/38), CR at 3 months was 61% (19/31) and CR at 6 months was 60% (12/20) where median follow-up as 6.3 months.
Grade 3 CRS and ICANS were reported from 14.6% (6/41), and 7.3% (3/41) respectively. No grade 4 CRS and ICANS were observed. Prolonged neutropenia, cytopenia, and serious infection were observed in 31.7% of patients (13/41), 49% of patients (20/41), and 10% of patients (4/41) respectively.
Curocell is planning on submitting an NDA to MFDS in mid-2024 and recently completed the construction of the largest commercial GMP facility for CAR-T production in Daejeon, Korea.
About anbalcabtagene autoleucel (anbal-cel)
Anbal-cel, recognized CD19 and is based on OVIS™, a first-in-class CAR-T platform. OVIS™ technology downregulates PD1 and TIGIT expression on CAR-T cells. Through overcoming the immune suppression by PD-1 and TIGIT ligands, OVIS™ CAR-T has superior cytotoxicity to tumor cells in the tumor microenvironment. Anbal-cel is in a Phase II clinical trial in patients wit DLBCL in South Korea.
Curocell, based in Daejeon, South Korea, is clinical-stage biotech innovating CAR-T therapies. Curocell is developing OVIS™ technology with the goal of improving the clinical efficacy of CAR-T therapies. Curocell is conducting a Phase II clinical trial of Anbal-cel in South Korea and is preparing to commercialize CAR-T therapies to bring innovative treatments to patients, including establishing the first and largest commercial GMP for CAR-T therapies in South Korea.
For more information, visit curocellbtx.com/en.
Details of the oral presentation at ICML are as follows:
Program and Abstract Book Nr. 45
Title: Phase 2 Study of Anbal-cel, Novel Anti-CD19 CAR-T therapy with Dual Silencing of PD-1 and TIGIT in Relapsed or Refractory Large B Cell Lymphoma-Interim Analysis Result
Session Title: New CAR-T cell Approaches
Session date and time: June 15, 2023, 15:30-15:45
Venue: Palazzo dei Congressi, Lugano
Session room: Room B