SPARC submits application for its ADC to US FDA to conduct global phase-1 study

Sun Pharma Advanced Research Company (SPARC) said that it has submitted an investigational new drug (IND) application with the US Food and Drug Administration (FDA) for its antibody-drug conjugate (ADC) SBO-154.

The IND application supports the next phase of development of SBO-154 which has completed the required IND-enabling preclinical studies with favorable results. A global phase-1 dose-escalation and expansion study has been planned to evaluate SBO-154 in treatment of solid tumors.

Antibodydrug conjugates or ADCs are a class of biopharmaceutical drugs designed as a targeted therapy for treating cancer. Unlike chemotherapy, ADCs are intended to target and kill tumor cells while sparing healthy cells.

SBO-154 is a novel humanized 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 internalization 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 startup from the University of Tel Aviv.

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."

Sun Pharma Advanced Research Company (SPARC) is a pharmaceutical company focused on continuously improving standards of care for patients globally through innovation in therapeutics and delivery.

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