Glenmark-Ichnos cancer drug shows 74% response in phase-1 trial

Mint

02-06-2025

Mumbai: Ichnos Glenmark Innovation (IGI), a joint venture between Glenmark Pharmaceuticals and Ichnos Sciences, on Monday shared promising results from an ongoing phase-1 trial of ISB 2001, a novel drug targeting relapsed or refractory multiple myeloma.
The data, presented at the 2025 Annual Meeting of the American Society of Clinical Oncology (ASCO), showed an overall response rate (ORR) of 74% in heavily pre-treated patients.
Refractory multiple myeloma refers to cases where the cancer does not respond or stops responding to treatment. Multiple myeloma is a rare, incurable blood cancer affecting plasma cells. While several therapies have been approved in recent years, most patients eventually relapse or become resistant, leaving limited treatment options.
ISB 2001 is being developed by IGI to address this unmet need, particularly in patients who have previously received T-cell–based therapies such as CAR T-cells or bispecific antibodies.
It is a first-in-class tri-specific antibody designed to simultaneously target BCMA, CD38, and CD3—three proteins associated with multiple myeloma. The drug aims to overcome resistance mechanisms seen with earlier-generation immunotherapies, while minimizing off-tumour toxicity.
The phase-1 trial, known as TRIgnite-1, is evaluating the drug's safety and efficacy in patients who have exhausted standard treatment options. The latest data, from the full dose-escalation phase, covered 35 patients with a median of six prior lines of therapy. The overall response rate was 74%.
'The high response rates and low safety concerns demonstrated in the dose-escalation portion of the TRIgnite-1 study, conducted in a heavily pre-treated population across multiple types of therapies, reinforce the promise of ISB 2001 as a potential new treatment for patients,' said Lida Pacaud, M.D., chief medical officer at IGI.
'As we advance to the second part of the TRIgnite-1 study, our focus is now on defining the recommended dosing schedule and evaluating ISB 2001 in a larger population of heavily pre-treated RRMM patients, where we hope to observe similarly impressive treatment responses and tolerability,' Pacaud said.
Among patients receiving higher, active dose levels (≥50 µg/kg), the ORR rose to 79%, with 30% achieving complete or stringent complete responses. Patients who had not previously received T-cell–based treatments saw an ORR of 84%. Even among those with prior exposure to CAR T or CD38-targeted therapies, response rates remained strong, ranging from 71% to 73%.
The safety profile of ISB 2001 was favourable, with no dose-limiting toxicities reported. The most common side effect was cytokine release syndrome (CRS), seen in 69% of patients—mostly mild (Grade 1), with only four cases classified as moderate (Grade 2). There were no severe neurological adverse events.
The market for multiple myeloma is projected to grow to about $33 billion by 2030, according to estimates by Bloomberg Intelligence.
The trial has now entered its dose-expansion phase, which will determine the recommended Phase 2 dose and optimal dosing schedule.
ISB 2001 was granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) in 2023 and recently received Fast Track status, underscoring the agency's recognition of its potential.