New York-based Ichnos Glenmark Innovation (IGI), a clinical-stage biotechnology subsidiary of Glenmark Pharmaceuticals, has announced significant progress in the development of ISB 2301, an experimental cancer therapy targeting solid tumors.
This innovative drug candidate belongs to a new class of “multispecific antibodies” engineered to identify cancer cells with greater precision and activate the body’s own immune system against them. ISB 2301 is being developed to treat challenging solid tumors, including lung, breast, and colorectal cancers, areas where many existing immunotherapies have struggled to show consistent efficacy.
Unlike conventional antibody drugs that typically focus on a single cancer marker, ISB 2301 is designed to simultaneously recognize three distinct tumor-associated markers. Concurrently, it activates two crucial types of immune cells: T cells and natural killer (NK) cells, both vital for destroying cancerous cells.
Lida Pacaud, President and CEO of IGI, emphasized the therapy's unique approach. “We engineered ISB 2301 to match the biological complexity of solid tumors in a way that conventional immunotherapies have not been able to address,” Pacaud stated.
Preclinical animal studies have demonstrated favorable safety, tolerability, and pharmacokinetic data for ISB 2301. These findings suggest the drug remains in the body long enough to potentially exert its therapeutic activity effectively. The company noted that ISB 2301 is designed to trigger multiple anti-cancer mechanisms simultaneously, including antibody-dependent cellular cytotoxicity (ADCC), a process where immune cells are directed to kill tumor cells.
IGI plans to submit an Investigational New Drug (IND) application to regulatory authorities by the end of 2026, a critical step required before commencing human clinical trials. The company anticipates initiating these clinical studies in 2027.
This advancement builds on IGI’s efforts to strengthen its pipeline of next-generation cancer biologics, utilizing its proprietary BEAT technology platform designed for engineering complex multispecific antibodies. The company previously garnered attention for its experimental cancer asset, ISB 2001, which led to a collaboration with AbbVie, validating its underlying platform technology.