Ichnos Glenmark Innovation (IGI) presented positive Phase 1 trial data for ISB 2001, a novel trispecific antibody targeting BCMA, CD38, and CD3, in patients with relapsed or refractory multiple myeloma (RRMM). The therapy demonstrated a 74% overall response rate (ORR) across nine dose levels in heavily pre-treated patients, with a median of six prior lines of therapy. The FDA recently granted ISB 2001 Fast Track Designation.
This positive data is particularly encouraging for RRMM patients who have limited treatment options after exhausting currently available therapies, especially those who have failed previous T-cell redirecting, BCMA-targeted, or anti-CD38 therapies. The high response rate observed, even in patients with prior exposure to these therapies, suggests ISB 2001 could overcome resistance mechanisms that limit the efficacy of current treatments. This opens up possibilities for patients who have historically had few options after progressing on existing therapies.
In the trial, the ORR was 79% in patients treated at active dose levels (≥ 50 µg/kg), with a complete/stringent complete response rate of 30%. Importantly, the ORR remained high across subgroups, including patients refractory to anti-CD38 therapies (72%), those with prior T-cell directed therapy (71%), and those with prior BCMA-targeted therapies (73%). The safety profile was favorable, with mostly low-grade cytokine release syndrome (CRS) and a low incidence of serious infections. The median half-life of ISB 2001 was approximately 17 days, suggesting potential for less frequent dosing.
The promising results from the Phase 1 trial set the stage for further investigation of ISB 2001. The ongoing dose-expansion portion of the study will determine the recommended Phase 2 dose and optimal dosing schedule, paving the way for a potential registrational study. If the efficacy and safety profile observed in the Phase 1 trial are confirmed in larger studies, ISB 2001 could become a valuable new treatment option for RRMM patients, particularly those with limited remaining options.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
