I-Mab Announces Portfolio Prioritization of Givastomig (CLDN18.2 x 4-1BB Bispecific Antibody) as Lead Clinical Program

Core Viewpoint - I-Mab is focusing on advancing its lead program, givastomig, a bispecific antibody targeting CLDN18.2 for the treatment of first-line metastatic gastric cancers and potentially other solid tumors, as part of its strategic outlook for 2025 [1][2][3] Portfolio Prioritization - Givastomig (TJ033721 / ABL111) is designed to target CLDN18.2-positive tumor cells and conditionally activate T cells through the 4-1BB signaling pathway [3] - The drug has shown strong tumor-binding properties and anti-tumor activity in Phase 1 trials, with a favorable safety profile and minimal toxicities compared to other 4-1BB agents [3][6] - A Phase 1b dose escalation study of givastomig in combination with nivolumab plus chemotherapy has been fully enrolled, with data expected in early second half of 2025 [5][6] Financial Outlook - The company reported a cash balance of $184.4 million as of September 30, 2024, which is expected to support operations into 2027 [5][8] - The current cash position is anticipated to fund the givastomig Phase 1b study through dose expansion data readouts and further development initiatives [8] Clinical Development - The company has completed enrollment of a dose escalation study of givastomig, with an overall response rate of 16.3% observed in early data [6] - The ongoing studies are evaluating patients with tumors expressing CLDN18.2, regardless of PD-L1 expression, with data from a 40-patient dose expansion study expected in early 2026 [6] Strategic Focus - The company has paused the development of uliledlimab to concentrate resources on advancing givastomig, while continuing to monitor data from ongoing studies [11]