Ichnos Glenmark Innovation (IGI), a collaboration between Glenmark Pharmaceuticals Limited and Ichnos Sciences Inc., has unveiled promising results from its Phase 1 clinical trial involving the trispecific antibody ISB 2001. The announcement was made ahead of the 66th American Society of Hematology (ASH) Annual Meeting, which is set to take place in December 2024 in San Diego, California. This data could signify a significant breakthrough for patients with relapsed or refractory multiple myeloma (r/r MM), a condition known for its treatment challenges and resistance development.

ISB 2001, developed through IGI’s proprietary BEAT® (Bispecific Engagement by Antibodies based on the TCR) technology, is a first-of-its-kind trispecific antibody that targets BCMA and CD38 on multiple myeloma cells while engaging CD3 on T cells. The results from this early-phase trial showcased an impressive overall response rate (ORR) of 75% in efficacy-evaluable patients. The data further highlighted that one of the patients achieved a minimal residual disease (MRD) negative stringent complete response, which is particularly noteworthy in the context of heavily pretreated patient populations.

Early results demonstrate safety and effectiveness

The Phase 1 trial data, collected as of July 2024, presented an encouraging safety and tolerability profile for ISB 2001. Importantly, the trial did not encounter any dose-limiting toxicities, with only one Grade 2 or higher adverse event reported, which did not lead to treatment discontinuation. Dr. Lida Pacaud, the Chief Medical Officer at IGI, emphasized the need for innovative solutions in treating r/r MM, noting that current therapies, while effective, often face limitations due to resistance mechanisms. She indicated that the initial findings support ISB 2001’s potential as a viable treatment alternative for patients who have exhausted other therapeutic options.

Further data to be presented at ash 2024

The oral presentation, scheduled for December 9, 2024, will delve into the dose-escalation segment of the study and include comprehensive data analysis. The session will be led by Professor Hang Quach, an esteemed haematologist affiliated with the University of Melbourne and St. Vincent’s Hospital Melbourne. Another promising candidate from IGI’s portfolio, ISB 1442, a biparatopic CD38 x CD47 bispecific antibody, will be featured in a poster session during the same meeting. This investigational therapy is currently being assessed in a Phase 1/2 study to evaluate its safety and efficacy in r/r MM.

About ichnos glenmark innovation

IGI operates as a collaborative force between Glenmark Pharmaceuticals and Ichnos Sciences Inc., combining expertise in small molecule drug development and novel biologics to advance treatments for cancer, including hematological malignancies and solid tumors. With research facilities spread across the U.S., Switzerland, and India, and a dedicated team of over 150 scientists, IGI aims to pioneer multispecific therapies that offer new hope for patients facing complex oncological diseases.

Expert insights on the trial’s impact

Industry experts have noted that the development of trispecific antibodies marks an important evolution in targeted cancer therapies. The ability of ISB 2001 to engage multiple receptors and cell types simultaneously could potentially enhance efficacy and address drug resistance seen in traditional monotherapies. The presentation of these results at a leading event like the ASH Annual Meeting highlights the clinical community’s growing interest in such advancements.

  American Society of Hematology, Glenmark Pharmaceuticals, Hang Quach, Ichnos Glenmark Innovation, Lida Pacaud