The investigational therapy has been engineered to simultaneously target three tumour-associated antigens while activating both T cells and natural killer cells to stimulate the immune system and drive tumour cell destruction. The company believes the approach could offer a new pathway for addressing the biological complexity of solid tumours that has historically challenged conventional immunotherapies.

According to IGI, ISB 2301 has been designed to induce multiple anti-cancer mechanisms, including Antibody-Dependent Cellular Cytotoxicity (ADCC), checkpoint inhibition and sustained Type 1 immune responses. By combining several therapeutic mechanisms within a single molecule, the company aims to enhance immune activation and improve treatment effectiveness across a range of solid cancers.

Lida Pacaud, President and Chief Executive Officer of IGI, said the therapy was developed to address limitations seen with traditional immunotherapy approaches. She noted that the molecule’s ability to simultaneously engage multiple tumour targets and immune cell types could establish a new benchmark for multispecific antibody development in solid tumour oncology.

The company developed ISB 2301 using its proprietary BEAT technology platform, which enables the engineering of complex multispecific antibody structures while maintaining compatibility with standard manufacturing processes.

Preclinical findings have demonstrated favourable pharmacokinetics, tolerability and safety characteristics in non-human primate studies. Based on these results, IGI plans to submit an Investigational New Drug (IND) application by the end of the year and aims to begin clinical trials in 2027.

The announcement builds on momentum generated by IGI’s previous lead investigational candidate, ISB 2001, which achieved early-stage clinical progress and supported a strategic collaboration with AbbVie. The company stated that lessons and technological capabilities developed through earlier programs contributed to the creation of ISB 2301.

IGI is focused on advancing first-in-class multispecific biologics designed to address complex diseases in oncology through integrated immune-targeting approaches. Headquartered in New York, the company continues to expand its pipeline of multispecific therapies aimed at improving treatment outcomes for patients with cancer.