ABL Bio (298380.KQ) said Tuesday it has submitted an application to the Ministry of Food and Drug Safety to amend the Phase 1 investigational new drug (IND) plan for ABL503 (ragistomig), a bispecific immuno-oncology antibody. The change aims to expand the trial beyond monotherapy in patients with solid tumors to include combination therapy with a PD-1 inhibitor.
ABL503 is a PD-L1·4-1BB-targeting bispecific antibody candidate being jointly developed by ABL Bio and U.S. biotech firm NovaBridge Biosciences. It was developed to improve resistance and low response rates, which are limitations of existing PD-(L)1 inhibitors, and is currently in Phase 1 trials. The Phase 1 trial is being conducted at more than eight institutions in Korea and the United States.
Through this IND amendment, ABL Bio has added a monotherapy cohort targeting a new cancer type to the tumor expansion part of ABL503's existing Phase 1 trial. The company also plans to newly conduct dose-escalation and expansion parts to evaluate the combination therapy of ABL503 and a PD-1 inhibitor.
The primary endpoints of this Phase 1 trial are safety and tolerability, based on factors including dose-limiting toxicity (DLT), adverse events (AE), cytokine release syndrome (CRS), and infusion-related reactions (IRR). In addition, the trial will also evaluate indicators related to preliminary anti-tumor activity, including objective response rate (ORR), duration of response (DOR), and disease control rate (DCR).
"With this IND amendment, we have expanded ABL503's clinical development strategy from monotherapy to combination therapy," ABL Bio CEO Lee Sang-hoon said. "As ABL111 (givastomig), another candidate to which the 4-1BB-based bispecific antibody platform Grabody-T is applied, is drawing significant attention with encouraging clinical data in combination therapy with chemotherapy and PD-1 inhibitors, we expect to confirm positive results in ABL503's combination therapy."
