Ichnos Glenmark Innovation (IGI) on Tuesday presented first-time clinical data from the early dose-escalation portion of its Phase 1 study of ISB 2001 for the treatment of relapsed or refractory multiple myeloma (RRMM).
According to the company’s statement, ISB 2001 is an investigational trispecific TREAT antibody for the treatment of RRMM that targets BCMA and CD38 on myeloma cells and CD3 on T cells. Initial results from 20 patients treated as of October 1, 2024, demonstrated an overall response rate (ORR) of 75% (15/20) across all doses tested (0.005 to 1.2 mg/kg), with a stringent complete remission (sCR) and complete remission (CR) rate of 20%.
The data were presented today during an oral session at the 66 th American Society of Hematology (ASH) Annual Meeting in San Diego, CA.
“The data presented today on ISB 2001 highlight its remarkable effectiveness as a novel trispecific-antibody T cell engager,” said Professor Hang Quach, M.D., Professor of Haematology at the University of Melbourne and Director of Haematology at St Vincent’s Hospital Melbourne. “These results are among the most impressive I have seen in this patient population. ISB 2001 has the potential to revolutionize the treatment landscape for heavily pretreated patients with multiple myeloma who have exhausted currently approved therapies.”
ISB 2001 was designed to enhance avidity with two binders targeting distinct myeloma-associated antigens – even at low expression levels – while offering improved safety compared to first-generation bispecific antibodies. IGI is developing ISB 2001 to meet the critical needs of RRMM patients, who have received prior T-cell directed therapies (including CAR-T cells and bispecifics), the company stated.
“Early data based on only 20 patients are encouraging. ISB 2001 showed high clinical responses in a heavily pretreated and advanced patient population. Combined with a favorable safety and tolerability profile, these findings suggest ISB 2001 could represent a major advance in the treatment of RRMM in the future,” said Lida Pacaud, M.D., Chief Medical Officer at IGI. “We are excited to advance the development of ISB 2001 by completing dose-escalation and moving swiftly into the dose-expansion part of the trial to establish the recommended Phase 2 dose and optimal dosing schedule.”
The company also stated that ISB 2001 was developed using IGI’s proprietary BEAT protein platform, which combines TCR interface-based heavy chain pairing and universal light chain technology to create multispecific antibodies.
“This innovative design can increase binding to tumor cells while minimizing on-target, off-tumor side effects and/or boost immune cell activity against tumor cells by triggering multiple signals,” it added.
“While there have been significant advancements in treatments for relapsed/refractory multiple myeloma, many patients still experience relapse. IGI designed ISB 2001 to offer a therapeutic option to patients who have previously received T-cell directed therapies including first-gen bispecific and CAR-T cell therapies,” said Cyril Konto, M.D., President and CEO of IGI. “These results further validate IGI’s BEAT technology which addresses the stability and engineering bottlenecks that previously hindered the large-scale production of bispecific and multispecific antibodies.”
