Glenmark Pharmaceuticals’ innovation arm, Ichnos Glenmark Innovation (IGI), has completed pre‑clinical development of ISB 2301, a next‑generation multispecific antibody for solid tumors, and is preparing to move the candidate into clinical trials.
ISB 2301 is a first‑in‑class, multispecific immune‑cell activator designed to simultaneously target three tumor‑associated antigens on solid‑tumor cells while engaging both T cells and natural killer (NK) cells to drive tumor‑cell death. The candidate is intended for use in multiple solid‑tumor indications, including breast, lung and other epithelial‑driven cancers, where conventional immunotherapies often struggle to deliver durable control.
IGI engineered ISB 2301 to harness antibody‑dependent cellular cytotoxicity (ADCC), checkpoint‑inhibition‑like activity, and a sustained type 1 immune response, using its proprietary BEAT® platform that has already delivered the blood‑cancer candidate ISB 2001. The platform enabled the design of a highly complex, tri‑specific antibody that can still be manufactured via standard multispecific antibody processes, supporting scalable development and commercialization.
Pre‑clinical studies in non‑human primates have demonstrated favorable safety, tolerability and pharmacokinetic properties, with the molecule showing adequate exposure and a clean toxicology profile. These data underpin IGI’s decision to advance ISB 2301 toward human testing, with an Investigational New Drug (IND) submission to U.S. regulators planned by the end of 2026.
IGI expects to initiate first‑in‑human clinical trials of ISB 2301 in solid tumors in 2027, building on the clinical validation of the BEAT® platform through ISB 2001’s strong early‑stage data in relapsed‑refractory multiple myeloma. The progression of ISB 2301 signals Glenmark’s increasing focus on multispecific antibodies as a core innovation pillar, with the company positioning these agents to address both hematological and solid‑tumor indications through immune‑cell engagement.
By combining multi‑target engagement with dual T‑cell and NK‑cell activation, ISB 2301 offers a novel immunotherapeutic strategy for solid tumors. It strengthens IGI’s emerging pipeline of next‑generation biologics in oncology.
