Glenmark Pharmaceuticals Limited has informed the Exchange regarding a press release dated Jun 02, 2025, titled "Full Dose-Escalation Data Show Continued High Response Rates and Favorable Safety Profile of ISB 2001, a First-in-Class BCMA � CD38 � CD3 Trispecific Antibody, for the Treatment of Relapsed/Refractory Multiple Myeloma".
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Glenmark's biotech alliance Ichnos Glenmark Innovation (IGI) presented updated Phase 1 results for ISB 2001, a first-in-class BCMA × CD38 × CD3 trispecific antibody, at the ASCO 2025 conference. In 35 heavily pretreated multiple myeloma patients (median six prior lines of therapy), the drug showed a 79% overall response rate and 30% complete/stringent complete response rate at active dose levels, with 74% ORR across all dose levels. Responses were strong even in patients who had previously failed CAR-T, bispecific, or BCMA-targeted therapies (71-73% ORR). The safety profile was favorable, with no dose-limiting toxicities and mostly mild cytokine release syndrome. The FDA granted ISB 2001 Fast Track Designation in May 2025, and the dose-expansion phase of the study is now underway.
This is a constructive pipeline update that strengthens the long-term story around Glenmark's innovative biologics arm IGI, though near-term stock impact may be limited as the asset is still early-stage. The strong efficacy in hard-to-treat patients, combined with FDA Fast Track status, reduces clinical risk and could attract future partnership or licensing interest.