Fast Track to Hope: Glenmark’s ISB 2001 Zooms Past FDA Hurdles

Ichnos Glenmark Innovation (IGI), a company co-owned by Ichnos Sciences and Glenmark Pharmaceuticals, reported that the US. Food and Drug Administration (FDA) has granted Fast Track designation to its experimental trispecific antibody, ISB 2001. The designation is for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received a minimum of three previous lines of therapy. The announcement is a big leap in the development of new treatments for patients with few treatment options.

 

Key Points

 

About the Fast Track Designation

The FDA Fast Track program speeds development and review of medications for serious disease conditions that have unmet medical needs, enabling potential earlier access by patients to new treatments that show promise.

 

ISB 2001 can now avail themselves of more regular FDA meetings, rolling review of submissions for regulations, and eligibility for Priority Review when specified requirements are fulfilled. 

 

About ISB 2001

ISB 2001 is a first-in-class trispecific antibody targeting BCMA and CD38 on myeloma cells and CD3 on T cells to engage the immune system to fight cancer more effectively.

 

The treatment has been engineered to improve tumor targeting and minimize off-tumor toxicity, with the potential for better outcomes in patients who have relapsed after multiple prior therapies, including bispecific antibodies and CAR T-cell therapies.

 

Clinical Progress and Results

ISB 2001 is presently being tested in a worldwide Phase 1 clinical trial, with centers in the US, Australia, and India.

 

Preliminary results of the dose-escalation segment of the Phase 1 trial indicate:

 

A total response rate (ORR) of 75% overall and 83% at active doses (0.05 mg/kg and higher).

 

Stringent complete remission (sCR) and complete remission (CR) rates of 20-22%.

 

A good safety and tolerability profile, with no dose-limiting toxicities at doses up to 1.2 mg/kg and mild cytokine release syndrome.

 

The treatment was active even in patients that had been previously treated with CAR-T or bispecific T-cell engagers, with an ORR of 75% in this subgroup.

 

The Phase 1 trial is proceeding to dose expansion, with additional results to be reported at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.

 

Expert Commentary

There has been an increasing number of pretreated patients with multiple myeloma, those who have progressed beyond currently approved treatments, who remain at risk of disease relapse. Our trispecific lead is structured to improve on tumor targeting, lower on-target, off-tumor toxicity.". We are pleased to be granted this Fast Track designation and look forward to closely collaborating with the FDA to move our Multispecific™ T-cell engager forward, with the hope of bringing a first-in-class treatment to patients with relapsed or refractory multiple myeloma."

 

Cyril Konto, M.D., President and CEO, IGI

 

Future Outlook

ISB 2001 was previously given FDA Orphan Drug Designation in July 2023, which recognized its potential to treat rare disease.

 

IGI is pursuing partnership opportunities to expedite the development and launch of ISB 2001, intending to launch this therapy as quickly as possible.

 

Sources: GlobeNewswire, Glenmark Pharmaceuticals, Clival, Express Pharma