Sun Pharma Advanced Research Company Ltd. (SPARC) has announced submission of an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA). The IND application supports the next phase of development of SBO-154 which has completed the required IND-enabling preclinical studies with favourable results. A global phase 1 dose-escalation and expansion study has been planned to evaluate SBO-154 in treatment of solid tumours.

Commenting on the development, said Anil Raghavan, CEO of SPARC said, “SBO-154, our first ADC is ready to advance in phase 1 with this IND submission, and this is an important milestone for SPARC as we hope to improve lives of cancer patients globally.”

SBO-154 is a novel humanised MUC1-SEA-targeted ADC developed by SPARC for the treatment of advanced solid tumours. SBO-154 specifically binds with high affinity to the SEA domain of MUC1, and functions by the release of the antimitotic payload after internalisation and cleavage. The released payload inhibits cell division and, thereby contributes to the shrinkage of tumours. SPARC had licensed anti-MUC1 antibody from Biomodifying – a start-up from the University of Tel Aviv.