-  82% ORR (9 of 11 patients) and 82% (9 of 11 patients) CR rate documented after  anbal-cel treatment to the patients in relapsed/refractory large B-cell lymphoma

-  2 out of 3 patients dosed with 2x10⁵ cells/kg of anbal-cel lasting the complete response for more than 12 months

-  Well tolerated up to 2X10⁶ cells/kg dose level without DLT and not reached to MTD in Phase 1 dose escalation study

DAEJEON, South Korea, June 13, 2022 /PRNewswire/ -- Curocell, Inc., a leading CAR-T company based in South Korea, announced the phase 1 dose-escalation study results documenting an 82% complete remission (CR) rate after a single dose of anbalcabtagene autoleucel (anbal-cel) to relapsed/refractory large B-cell lymphoma patients.

Three (3) among 4 patients dosed at 2x10⁵ cells/kg of anbal-cel documented complete remission, and 2 responding patients are maintaining the complete remission for more than a year. Strikingly, all patients dosed with 2x10⁶ cells/kg reported complete remission after a single dose of anbal-cel.

The complete phase 1 study results were presented at EHA at EHA (European Hematology Association) congress, Vienna, Austria, Jun 09-17, 2022.

The anbal-cel is the CD19 CAR-T integrated with the OVIS^TM (Overcome Immune Suppression) platform. OVIS^TM technology consists of a dual knockdown system for two crucial immune checkpoint receptors, PD-1 and TIGIT, in CAR-T cells.

"Although CD19 directed CAR-T therapy changed the treatment paradigm for Large B-cell lymphoma, which is one of the most aggressive hematologic malignant cancer, more than 50% of LBCL patients didn't experience the clinical benefit of CD19 CAR-T treatment, and there are still huge unmet medical needs. Anbal-cel's phase 1 study result demonstrates the OVIS^TM platform's potential to maximize CAR-T's functionality to eradicate tumors. We are very excited about this promising clinical result even though the patient number treated with anbal-cel is limited with a total of 11 and looking forward to the ongoing phase 2 clinical trial to confirm the efficacy and safety of anbal-cel. Furthermore, we believe these data represent the excellence of our next-generation CAR-T technology." said Gunsoo Kim, Curocell's chief executive officer.

This phase 1 study was to evaluate the safety and preliminary efficacy in patients with r/rLBCL. Patient was infused as a single intravenous dose with 2x10⁵ cells/kg (Dose Level 1), 7x10⁵ cells/kg (DL2) or 2x10⁶ cells/kg (DL3). Lymphodepletion with cyclophosphamide (500mg/m²) and fludarabine (30mg/m²) was performed for 3 days prior to anbal-cel infusion.

Eleven (11) patients with r/r DLBCL were infused with anbal-cel. All patients received two or more prior lines of therapy, and 36% (4/11) received ≥4 prior lines of treatment before the study. No patient experienced DLT during the study.

Of the 11 patients, 5 (46%) patients experienced CRS; 3 (27%) were grade 1 or 2 and 2 (18%) experienced grade 3 CRS. The median time to onset of CRS was 7 days (range, 1-16) with a median duration of 5 days (range, 1-19).

One patient dosed with 2x10⁶ cells/kg experienced grade 2 ICANS; the time to onset of ICANS was 7 days and lasted for 13 days. This patient had prior CNS involvement history before the study. The frequently reported grade 3/4 treatment related AEs were anemia (2/11, 18%), neutropenia (2/11, 18%), thrombocytopenia (2/11, 18%), CRS (2/11, 18%).

Dose-dependent CRC01 expansion was observed; median T_max was 15.4, 15.8 and 14.5 days at DL1, DL2 & DL3 each; C_max, AUC_0-28 day was dose proportionally increased.

Based on promising safety and efficacy data from Phase 1 study, Phase 2 trial has been commenced, and patient enrollment is ongoing.

Details of the oral presentation at EHA are as follows:

Submission ID: EHA-3438
Title: PHASE 1/2 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
Session Title: Aggressive Lymphoma - CART
Session date and time: Saturday, June 11 11:30 - 12:45
Session room: Hall A7
Final Abstract Code:  S214

Anbal-cel, recognized CD19 and is based on OVIS^TM, a first-in-class CAR-T platform. OVIS^TM technology downregulates PD1 and TIGIT expression in CAR-T cells. Through overcoming the immune suppression by PD-L1 and TIGIT ligands, OVIS^TM CAR-T has superior cytotoxicity to tumor cells in the tumor microenvironment. The Phase 2 clinical trial of anbal-cel has initiated in South Korea in the first half of 2022.

Curocell, based in Daejeon, South Korea, is clinical-stage biotech innovating CAR-T therapies. Curocell is developing OVIS^TM technology intending to improve the clinical efficacy of CAR-T therapies. For more information, visit  www.curocellbtx.com/en.