Submit Current Safety Data of Indians: CDSCO Panel Tells Glenmark on anti-cancer drug ISB1442

New Delhi: Reviewing the Phase I/II clinical study protocol of the anti-cancer drug ISB1442 presented by the drug major Glenmark, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to submit the current safety data including data of Indian subjects from the already approved clinical trial in India.

This came after the drug maker Glenmark presented Phase I/II clinical study protocol No. ISB 1442-102, version 1.0 dated 16 Feb 2024.

ISB 1442 is a bispecific, biparatopic antibody targeting CD38 and CD47, generated using Ichnos' Bispecific Engagement by Antibodies based on the T cell receptor (BEAT ) platform. ISB 1442 is designed to kill CD38-expressing tumor cells through multiple mechanisms of action including blocking the CD47-signal regulatory protein alpha (SIRPα) axis to increase several antibody effector functions: antibody-dependent cellular phagocytosis (ADCP), antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) through optimized architecture, affinity to targets, and Fc engineering.

ISB 1442 consists of two anti-CD38 arms targeting two distinct epitopes that preferentially drive binding to tumor cells and enable avidity-induced blocking of proximal CD47 receptors on the same cell while preventing on-target off-tumor binding on healthy cells. The Fc portion of ISB 1442 is engineered to enhance complement-dependent cytotoxicity, antibody-dependent cell cytotoxicity, and antibody dependent cell phagocytosis.

At the recent SEC meeting for Oncology on 5th March 2024, the expert panel reviewed the Phase I/II clinical study protocol No. ISB 1442-102, version 1.0 dated 16 Feb 2024 presented by the drug major Glenmark.

After detailed deliberation, the committee opined that the firm should submit current safety data including data of Indian subjects from an already approved clinical trial in India for further review by the committee.

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