🟢 At a Glance:
Glenmark’s biotech arm, IGI (Ichnos Glenmark Innovation), just dropped bombshell Phase 1 data at ASCO 2025. Their experimental cancer drug ISB 2001, a first-in-class trispecific antibody targeting BCMA × CD38 × CD3, showed a whopping 79% overall response rate (ORR) in relapsed/refractory multiple myeloma patients. That too in patients who had already been through an average of 6 failed treatments.
FDA has already granted Fast Track status — and this could be Glenmark’s biggest medical moonshot ever.
🧪 What is ISB 2001?
- Type: Trispecific T-cell engager antibody
- Targets: BCMA (B-cell maturation antigen), CD38 (myeloma marker),
- CD3 (T-cell activator)
- Platform: BEAT® (Glenmark’s proprietary multispecifics tech)
- Purpose: To kill myeloma cells even when antigen expression is low AND avoid toxicity from T-cell overstimulation
This is like three snipers embedded in one immune missile, designed to seek and destroy even stubborn multiple myeloma cells.
🔬 Trial Summary: TRIgnite-1 (Phase 1)
| Detail | Summary |
|---|---|
| Patients | 35 total (33 at ≥50 μg/kg active dose) |
| Prior Therapies | Median: 6 (range: 3–11) |
| Response Rate (ORR) | 79% at active dose levels |
| Complete/Stringent Complete Response | 30% |
| MRD Negativity | 6 of 8 patients tested |
| Safety | No dose-limiting toxicities (DLTs); mainly Grade 1 CRS |
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