Lantern Pharma (NASDAQ: LTRN) and its subsidiary, closely held Starlight Therapeutics, have announced FDA clearance of the investigational new drug (IND) application for STAR-001, in a planned Phase 1 pediatric clinical trial.
STAR-001 is a precision oncology compound whose central nervous system (CNS) and pediatric CNS indications were initially identified using Lantern’s proprietary RADR AI platform. The trial is planned to be conducted in collaboration with the Pediatric Oncology Experimental Therapeutics Investigators’ Consortium—a multicenter network of 14 leading academic children’s cancer centers across the United States, Canada, and Israel.
In a statement, Panna Sharma, CEO and president of Lantern, commented, “This IND clearance is a defining milestone for Starlight Therapeutics and a meaningful step forward for pediatric neuro-oncology. For children with relapsed or refractory CNS tumors, the options are desperately limited—and the science behind this planned trial was built to change that. CNS and pediatric CNS cancers were initially identified as priority indications by our team in support from our RADR AI platform, and that same analysis led us to ERCC3, a DNA repair enzyme that high-grade CNS tumors rely on to survive. Our modeling, analysis and subsequent in-vivo and animal studies showed that spironolactone could dismantle that pathway by degrading ERCC3 before STAR-001 even enters the cancer cell. In ATRT models, the combination extended median survival by 181% compared to the control. We believe this represents a genuinely new way to attack these brain cancers, and we are proud to be advancing it through a network of some of the world’s most respected pediatric oncology centers.”
