🟢 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 |
📊 Breakdown of Results (Selected Groups)
| Subgroup | ORR | CR/sCR |
|---|---|---|
| All Active Dose (≥50 μg/kg) | 79% | 30% |
| No prior CAR-T or bispecifics | 84% | 32% |
| Prior BCMA therapies | 73% | 27% |
| Prior T-cell directed therapies | 71% | 28% |
| Anti-CD38 refractory | 72% | 24% |
🧾 Safety Profile
- CRS (Cytokine Release Syndrome):
- Seen in 69% (mostly mild, no life-threatening cases)
- Neurological Adverse Events (ICANS):
- Just 1 patient (Grade 1)
- Infections:
- Only 11% had severe infections (no Grade 4+)
🔍 Why This Matters
- Trispecific is the new bispecific. This next-gen tech may solve resistance issues seen in CAR-T and traditional bispecific therapies.
- Fast Track from FDA = Regulatory green light to speed up trials.
- MRD negativity (no residual cancer cells) = real depth of remission.
- Fewer side effects = potential for outpatient administration.
🧠 EduInvesting Take
“Glenmark just did what most pharma giants struggle to do — make Phase 1 look like Phase 3 fireworks.”
Let’s be clear:
- It’s still early days — Phase 2 & 3 await
- But in oncology terms, this kind of response rate (79%) in heavily pretreated patients is jaw-dropping
- Combine that with solid safety, and Glenmark might finally have a blockbuster biologic on its hands
🧬 What’s Next?
- Dose-expansion trials are ongoing
- European enrollment starting soon
- Aims to find optimal dosage & schedule (Project Optimus compliant)
🚀 Big Picture for Glenmark
| Factor | Impact |
|---|---|
| Biotech Credibility | ✅ Skyrocketing |
| Potential Licensing | 💰 Could bring in upfront + milestone cash |
| Long-Term Valuation | 💎 If Phase 2/3 successful, game-changer for market cap |
📅 Published: 2 June 2025
✍️ Author: Prashant Marathe
🏷️ Tags: Glenmark, ISB 2001, ASCO 2025, Trispecific Antibody, Multiple Myeloma, FDA Fast Track, Cancer Trials, Oncology Breakthrough, IGI Biotech, BEAT Platform, CD38, BCMA, CD3
