Latest news with #LidaPacaud
&w=3840&q=100)
Business Standard
7 days ago
- Health
- Business Standard
Glenmark's cancer drug shows strong results in early trial for Myeloma
Glenmark Pharmaceuticals' arm, Ichnos Glenmark Innovation (IGI), shared encouraging early results from a new cancer drug being tested on patients with a difficult form of blood cancer—relapsed or refractory multiple myeloma (RRMM). The results were presented at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting. The drug, called ISB 2001, is the first of its kind to target three markers (BCMA, CD38, and CD3) in a single treatment and has shown strong response rates in patients who have already undergone multiple prior therapies. In the dose-escalation stage of the trial, 35 patients were treated, most of whom had received a median of six prior therapies. Among 33 patients who received active doses (50 micrograms and above), the overall response rate (ORR) was 79 per cent, and 30 per cent achieved a complete or near-complete response. Safety data showed that cytokine release syndrome (CRS) occurred in 69 per cent of patients, mostly at Grade 1 severity. Four patients experienced Grade 2 CRS, and no cases of severe CRS or dose-limiting toxicities were reported. One patient experienced a mild neurological side effect, and infection rates remained low. The trial is continuing with a dose-expansion phase to determine the recommended Phase 2 dose and the optimal dosing schedule. According to Professor Hang Quach of the University of Melbourne and St Vincent's Hospital, ISB 2001 showed activity in patients who had previously received multiple treatment types, including T-cell redirecting and BCMA-targeted therapies. Lida Pacaud, Chief Medical Officer at IGI, said the current focus is on identifying the appropriate dose and expanding the trial to a broader patient population.
Mint
7 days ago
- Business
- Mint
Glenmark-Ichnos cancer drug shows 74% response in phase-1 trial
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.
