Glenmark's research arm gets USFDA fast track status for new drug to treat multiple Myeloma

Glenmark Pharmaceuticals' research and innovation arm Ichnos Glenmark Innovation (IGI) on Monday announced that the US Food and Drug Administration (FDA) has granted fast track designation for a new drug ISB 2001 used to treat multiple Myeloma.

"This important designation was granted for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least three prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. ISB 2001 is an investigational trispecific antibody therapeutic that targets BCMA and CD38 on myeloma cells and CD3 on T cells. ISB 2001 is currently being evaluated in a Phase 1 dose-expansion study," the company stated in a BSE filing.

"A growing number of patients with multiple myeloma have been heavily pretreated, have exhausted currently approved therapies, and continue to face disease progression," said Cyril Konto, MD, President and CEO of IGI.

"At IGI, we have long recognized the urgent need for novel treatment options – particularly for patients who have already received first-generation bispecifics or CAR T-cell therapies. Our trispecific candidate is designed to enhance tumor targeting while reducing on-target, off-tumor toxicity. We are honored to receive this Fast Track designation and look forward to working closely with the FDA to advance our MultispecificTM T-cell engager, with the goal of delivering a first-in-class therapy for patients with relapsed or refractory multiple myeloma."

IGI said it recently completed the dose-escalation portion of its Phase 1 clinical study in patients with heavily pretreated multiple myeloma. "Initial study results, presented in an oral session at the American Society of Hematology (ASH) Annual Meeting in December 2024, demonstrated a high overall response rate (ORR) with durable responses and a favourable safety profile. Complete results from the dose-escalation portion will be presented in a rapid oral session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting on Monday, June 2, 2025," it mentioned.

A drug that receives fast track designation may be eligible for more frequent meetings and communications with the FDA and rolling review of any application for marketing approval. "A drug receiving fast track tag also may be eligible for priority review if relevant criteria are met. ISB 2001 was previously granted Orphan Drug Designation by the FDA in July 2023," the pharma giant added.

IGI is an integrated clinical-stage biotechnology company focused on developing multispecifics in oncology. Meanwhile, shares of Glenmark Pharma settled 1.79 per cent higher at Rs 1,400.30 today.