Sun Pharma Advanced Research Company submits IND application for SBO-154 to USFDA
Mumbai: Sun Pharma Advanced Research Company Ltd. 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 favorable results. A global phase 1 dose-escalation and expansion study has been planned to evaluate SBO-154 in treatment of solid tumors.
“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.” said Anil Raghavan, CEO of SPARC.
SBO-154 is a novel humanized MUC1-SEA-targeted ADC developed by SPARC for the treatment of advanced solid tumors. 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 tumors. SPARC had licensed anti-MUC1 antibody from Biomodifying a startup from the University of Tel Aviv.
Read also: SPARC announces retirement of Dr Chitturi Trinadha Rao - Senior Vice President, Drug Discovery
Medical Dialogues team had earlier reported that the Company had signed of a binding Letter of Intent (LOI) with the University of California, San Francisco (UCSF) through the office of OTMA, and Tiller Therapeutics Inc. to license SPARC’s rights in the joint intellectual property (IP) held between SPARC and UCSF for pre-clinical oncology asset along with associated IP.
SPARC is a clinical stage bio-pharmaceutical company. SPARC was formed in 2007 through a demerger from SUN PHARMA.
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