#USA #New York #Multiple Myeloma #Ichnos Glenmark #ISB 2001

Promising Data on ISB 2001 for Multiple Myeloma Treatment

Ichnos Glenmark Innovation (IGI) has recently announced groundbreaking results from their Phase 1 TRIgnite-1 study, which investigates ISB 2001, an innovative trispecific antibody designed for treating relapsed or refractory multiple myeloma (RRMM). This study was presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in 2025, highlighting the promising potential of this first-in-class therapy.

The results of the study indicated a remarkable overall response rate (ORR) of 74% across multiple dose levels, with particularly high efficacy observed in patients previously untreated by CAR-T or bispecific therapies, achieving an astounding ORR of 84%. Such results underscore ISB 2001's potential to engage the immune system effectively against cancer cells, especially in a patient population that has often exhausted treatment options.

High Response Rates in a Challenging Cohort

In a cohort characterized by heavy pretreatment, the study included 35 patients who had undergone a median of six prior lines of therapy, showcasing an impressive ORR of 79% among those treated with higher doses (≥ 50 µg/kg). Within this promising response rate, a complete or stringent complete remission (CR/sCR) was achieved in 30% of patients, indicating a robust anti-myeloma activity needed desperately in such challenging cases. Furthermore, evaluations for minimal residual disease (MRD) revealed that six out of eight assessable patients achieved MRD negativity, projecting a strong indication of sustained remission.

The study addressed various subgroups of this heavily pretreated population, including those refractory to existing therapies. In patients who had previously received anti-CD38 therapies, the ORR was 72%, while an impressive 84% response rate was observed in patients without prior exposure to T-cell redirected therapies.

Safety Profile and Regulatory Designations

Beyond its efficacy, ISB 2001 continues to demonstrate a favorable safety profile, an essential factor for any cancer treatment. Throughout the dose-escalation phase, no dose-limiting toxicities were recorded. Notably, 69% of patients experienced cytokine release syndrome (CRS), primarily of Grade 1 severity. Even with a few Grade 2 cases, the absence of severe or life-threatening reactions points towards ISB 2001's relatively mild toxicity compared to traditional therapies.

The treatment plan is gaining traction; the U.S. FDA has granted ISB 2001 Fast Track Designation, which enhances the development path for this promising medication.

Future Prospects

As the study progresses, the dose-expansion phase is anticipated to help establish the recommended Phase 2 dose and finalize the optimal treatment schedule. Dr. Lida Pacaud, Chief Medical Officer at IGI, expressed optimism regarding ISB 2001's potential: “The high response rates and minimal safety concerns demonstrated in this heavily pretreated population reinforce the promise of ISB 2001 as a potential new treatment for patients afflicted with multiple myeloma.”

The TRIgnite-1 study, ongoing in the U.S. and Australia, aims to solidify ISB 2001’s position as an essential therapeutic option for RRMM patients. With the pressing need for new treatment avenues, ISB 2001 represents a beacon of hope for many patients facing this challenging diagnosis.

Conclusion

In summary, the findings from the TRIgnite-1 study provide substantial evidence of ISB 2001's capabilities in managing RRMM, with high response rates and a manageable safety profile. This trispecific antibody could redefine treatment paradigms for patients whose options have been severely limited. Ichnos Glenmark Innovation's commitment to addressing this unmet need highlights the importance of ongoing research in the fight against multiple myeloma.