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