Lantern Pharma announces completion of Type C meeting with FDA

Lantern Pharma (LTRN) announced the successful completion of a Type C meeting with the U.S. FDA. The meeting provided critical guidance on the regulatory pathway and trial design for a planned pediatric trial focused on CNS cancers, including Atypical Teratoid Rhabdoid Tumor.During the Type C meeting, the FDA provided constructive feedback on the proposed clinical trial structure, which includes a parallel cohort specifically for ATRT patients to accelerate data collection in this ultra-rare population. Additionally, the agency confirmed the potential incorporation of spironolactone as a combination agent, to allow for the assessment of spironolactone’s synergistic effects with Lantern’s lead investigational therapy, LP-184/STAR-001 in enhancing the potential efficacy in CNS cancers. This feedback aligns with Lantern’s strategy to advance precision oncology solutions for pediatric patients facing limited treatment options. Lantern is now preparing to submit an IND application amendment for LP-184/STAR-001 under its wholly owned subsidiary, Starlight Therapeutics, based on the guidance and dialogue from the Type C meeting. Lantern’s program for ATRT has received Rare Pediatric Disease Designation and Orphan Drug Designation from the FDA, underscoring the urgent unmet need for innovative therapies in these aggressive childhood brain cancers. The planned trial is expected to enroll pediatric patients across multiple sites, with primary endpoints focused on progression-free survival, overall response rate, and quality-of-life measures. “We are thrilled with the constructive dialogue and positive feedback from our Type C meeting with the FDA,” said Panna Sharma, President and CEO of Lantern Pharma. “This guidance not only reinforces our trial design but also highlights the potential of our AI platform, RADR, in identifying and optimizing combination regimens like spironolactone for these devastating pediatric CNS cancers. We remain committed to rapidly advancing this program with the aim of bringing hope to children and families affected by brain cancer.” Lantern Pharma continues to leverage its proprietary RADR AI platform to accelerate drug development, reduce costs, and identify patient responders across oncology indications. The company plans to submit an Investigational New Drug application amendment incorporating the FDA’s guidance in the coming months, with planned trial initiation targeted for Q1 2026.