Glenmark Pharmaceuticals shares in focus on drug update to treat multiple Myeloma

Shares of Glenmark Pharmaceuticals are in news today after the firm said its innovation division, Ichnos Glenmark Innovation (IGI), announced on Monday that the US Food and Drug Administration (FDA) has awarded fast track designation for a new drug ISB 2001 aimed at treating multiple myeloma. Shares of Glenmark Pharma settled 1.79 per cent higher at Rs 1,400.30 on Monday. 

"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 said 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 reported that it has recently wrapped up the dose-escalation phase of its Phase 1 clinical trial involving patients with heavily pretreated multiple myeloma. Initial study outcomes, shared during an oral presentation at the American Society of Hematology (ASH) Annual Meeting in December 2024, revealed a promising overall response rate (ORR) along with sustained responses and a favorable safety profile. Comprehensive results from the dose-escalation phase are set to be unveiled in a rapid oral session at the upcoming 2025 American Society of Clinical Oncology (ASCO) Annual Meeting on Monday, June 2, 2025.

Drugs that receive fast track designation can benefit from enhanced communications with the FDA and may qualify for a rolling review process for marketing approval.

IGI is an integrated clinical-stage biotechnology firm dedicated to advancing multispecific therapies in oncology.