ABL Bio Inc. unveils clinical results for bispecific immuno-oncology candidates, accelerates follow-up development

[Financial News] ABL Bio Inc. is releasing clinical data on two bispecific immuno-oncology drug candidates and accelerating their further development. Givastomig has completed discussions with the U.S. Food and Drug Administration (FDA) on the design of its Phase 3 trial, while Ragistomig was found to maintain antitumor activity despite an extended dosing interval.
ABL Bio Inc. said on the 26th that it presented clinical results for Givastomig (ABL111) and Ragistomig (ABL503) at the European Society for Medical Oncology (ESMO). The two candidates are 4-1BB-based bispecific antibodies that activate immune responses against cancer cells, and are being co-developed with U.S. company NovaBridge Biosciences.
Givastomig targets Claudin 18.2, which is expressed in gastric and pancreatic cancers, among others. In an additional analysis of the Phase 1b trial, the objective response rate (ORR) among the 29 patients in the 8 mg/kg dose group was 79% (23 patients), and the disease control rate (DCR) was 97% (28 patients). The objective response rate is the percentage of patients whose tumors shrink by at least a certain amount, while the disease control rate is the percentage whose tumors shrink or do not progress for a certain period.
The safety analysis reported no Grade 4 or 5 severe adverse events related to the drug. Gastritis, an immune-related adverse event, was mostly Grade 2.
The two companies selected 8 mg/kg as the dose for further clinical development after considering efficacy, safety and long-term follow-up results for the 8 mg/kg and 12 mg/kg dose groups. They completed discussions with the FDA on key elements of the Phase 3 trial design, which aims to secure global approval. Givastomig has also received FDA Orphan Drug and Fast Track designations.
Ragistomig, also unveiled, targets the immune checkpoint protein PD-L1. In a Phase 1 monotherapy trial, extending the dosing interval from two weeks to six weeks resulted in a lower rate of treatment-related adverse events of Grade 3 or higher than in the group dosed every two weeks. Despite the longer dosing interval, activation of CD8-positive T cells, a type of immune cell, continued, while regulatory T cells that suppress immune responses remained at baseline levels. Of the 13 patients who responded to treatment, 11 (84.6%) had either not responded to prior treatment with PD-(L)1 inhibitors or had relapsed after treatment. The results confirmed its potential as a new treatment option for patients for whom existing immuno-oncology treatment has failed.
ABL Bio Inc. plans to continue preparations for a Phase 3 trial of Givastomig while pursuing further clinical trials of Ragistomig, focusing on combination therapy with PD-1 inhibitors.
Lee Sang-hoon, CEO of ABL Bio Inc., said, “Long-term follow-up data for Givastomig confirmed the durability of its treatment effect and its safety, and we also made progress in discussions with the FDA,” adding, “Based on the results of optimizing the dosing schedule, we will also pursue clinical development of combination therapy for Ragistomig.”

[email protected] Jung Sang-hee Reporter