On March 7, 2025 I-Mab (NASDAQ: IMAB) (the "Company"), a U.S.-based, global biotech company, focused on the development of precision immuno-oncology agents for the treatment of cancer, reported that enrollment has been completed ahead of schedule in the first dose expansion cohort in the Phase 1b givastomig combination study, with continued momentum in the second dose expansion cohort (Press release, I-Mab Biopharma, MAR 7, 2025, View Source [SID1234651011]). The Phase 1b study is evaluating givastomig, a potential best-in-class, Claudin 18.2 (CLDN18.2) x 4-1BB bispecific antibody, targeting CLDN18.2-expressing tumor cells for the treatment of gastric cancer in the first-line (1L) setting. The Phase 1b program includes a dose escalation study (n=17) and a dose expansion study (n=40). Enrollment in the dose escalation study is complete, and topline data are expected in the second half of 2025.
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"The Phase 1b clinical program continues to show encouraging early data, with strong recruitment momentum. Enrollment in the first dose expansion cohort was completed months ahead of schedule and we are observing a similar rate of recruitment in the second expansion cohort," said Phillip Dennis, MD, PhD, Chief Medical Officer of I-Mab. "We hope that the data from these studies will help to establish the optimal dosing regimen and demonstrate givastomig’s potential to provide improved efficacy in the first-line treatment of patients with gastric cancers."
Sam Klempner, MD, Associate Professor of Medicine, Massachusetts General Hospital commented, "I believe the addition of novel Claudin 18.2-targeted therapies to existing standards has the potential to improve treatment outcomes for patients with gastric and gastroesophageal cancers. Givastomig’s activity across a range of CLDN18.2 expression levels and its overall tolerability in combination with standard chemotherapy and anti-PD-1 checkpoint inhibitors is encouraging and offers hope that we may be able to expand the population of patients benefitting from CLDN18.2-directed approaches. I look forward to ongoing participation in the Phase 1b clinical program and hope results of the study will validate the activity of a CLDN18.2 x 4-1BB bispecific strategy in gastroesophageal cancers."
The Phase 1b program is designed to evaluate givastomig’s safety, preliminary efficacy and pharmacokinetics as a potential first-line treatment for gastric cancer in combination with standard of care, nivolumab (an anti-PD-1 checkpoint inhibitor) plus chemotherapy.
About Givastomig
Givastomig (TJ033721 / ABL111) is a bispecific antibody targeting CLDN18.2-positive tumor cells. It conditionally activates T cells through the 4-1BB signaling pathway in the tumor microenvironment where CLDN18.2 is expressed. Givastomig is being developed for first-line metastatic gastric cancers, with additional potential in other solid tumors. In a Phase 1 monotherapy study, reported at the European Society for Medical Oncology in September 2024 (ESMO 2024), givastomig was observed to maintain a strong tumor-binding property and anti-tumor activity, attributable to a potential synergistic effect of proximal interaction with CLDN18.2 and 4-1BB, while minimizing toxicities commonly seen with other 4-1BB agents.
This program is being jointly developed through a global partnership with ABL Bio, in which I-Mab is the lead party and shares worldwide rights, excluding Greater China and South Korea, equally with ABL Bio.