SPARC seeks US FDA approval for Phase 1 trial of SBO-154 in solid tumors

India Pharma Outlook Team | Monday, 31 March 2025

 SPARC seeks US FDA approval for Phase 1 trial

Sun Pharma Advanced Research business Ltd (SPARC), a biopharmaceutical business in the clinical stage, said that it has submitted an Investigational New Drug (IND) application to the FDA in the United States. SBO-154's next stage of development is supported by the IND application, since it has successfully finished the necessary IND-enabling preclinical trials. SBO-154 will be evaluated in a global phase 1 dose-escalation and expansion research to treat 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.

SPARC created the innovative humanized MUC1-SEA-targeted ADC SBO-154 to treat advanced solid tumors. SBO-154 operates by releasing the antimitotic payload following internalization and cleavage, and it binds selectively and highly affinity to the SEA domain of MUC1. The payload that is released prevents cells from dividing, which helps tumors shrink. The anti-MUC1 antibody was licensed by SPARC from Biomodifying, a University of Tel Aviv business.

Sun Pharma Advanced Research firm Ltd. (SPARC) is a clinical-stage biopharmaceutical firm dedicated to advancing therapeutic and delivery innovation to consistently raise patient standards of care worldwide. Increasing the number of treatment options available to patients worldwide is the goal of SPARC.

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