On June 19, 2023 Curocell Inc, a Korea-based clinical-stage CAR-T cell therapy company, reported updated Phase 2 interim results for Anbalcabtagene-autoleucel (anbal-cel) on June 15, 2023, at ICML (International Conference on Malignant Lymphoma), Lugano, Switzerland (Press release, Curocell, JUN 19, 2023, View Source [SID1234632805]).

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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.