Ichnos Glenmark’s ISB 2001 Shows Promising Results in Phase 1 Myeloma Trial

On December 9, 2024, Ichnos Glenmark Innovation (IGI), a global clinical-stage biotech company, shared initial clinical data from its Phase 1 study of ISB 2001, a trispecific TREAT™ antibody. The results at the 66th American Society of Hematology (ASH) Annual Meeting in San Diego show potential for revolutionising multiple myeloma treatment.

Key Findings from the Phase 1 Study

• Trial Design:
  The study includes heavily pretreated patients with relapsed/refractory multiple myeloma (RRMM) who failed prior therapies, including CAR-T cells and bispecific antibodies. The trial focused on dose escalation and dose expansion across 6 US and Australian sites.
• Clinical Results:
  • 20 patients treated as of October 1, 2024.
  • Overall Response Rate (ORR): 75%, with active doses (≥0.05 mg/kg) showing an ORR of 83%.
  • Deep responses: 20% achieved stringent Complete Remission (sCR) or Complete Remission (CR).
  • Median response time: 36 days.
  • 80% of patients remained on treatment.
• Safety Profile:
  ISB 2001 demonstrated good tolerability with no dose-limiting toxicities. Grade 1 cytokine release syndrome (CRS) occurred in 65% of patients, with only 10% experiencing Grade 2 CRS. Injection site reactions (50%) were mild, and no neurotoxicity was observed.

Innovative Design and Potential Impact

ISB 2001, developed using IGI’s proprietary BEAT® platform, targets BCMA and CD38 on myeloma cells and CD3 on T cells. Its innovative tri-specific design improves binding to tumour cells while reducing off-target effects.

The drug offers a novel approach for patients who have relapsed after using first-generation bispecifics and CAR-T therapies. Durable and deep responses suggest the potential for less frequent dosing due to its long half-life of over 10 days.

A Breakthrough in Multiple Myeloma Treatment

According to Professor Hang Quach, M.D., of the University of Melbourne, ISB 2001 could transform the treatment landscape for RRMM patients. The results are among the most impressive seen in this challenging patient group.

About Ichnos Glenmark Innovation (IGI)

IGI is a collaboration between Ichnos Sciences and Glenmark Pharmaceuticals, combining expertise in biologics and small molecule drug discovery. With innovation centres in the USA, Switzerland, and India, IGI is advancing novel therapies for haematological and solid tumour cancers.

ISB 2001’s development highlights IGI’s commitment to addressing unmet needs in oncology with cutting-edge solutions.

Glenmark Pharmaceuticals share price is currently trading at ₹1,547.80, up by ₹33.65 or 2.22% as of 10:15 AM on December 10, 2024. The stock opened at ₹1,535.00, reached a high of ₹1,576.50, and a low of ₹1,521.00 during the day. The company’s market capitalisation stands at ₹43.68K crore, and it has a dividend yield of 0.16%. Glenmark’s 52-week high is ₹1,830.95, while the 52-week low is ₹771.00. 

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