Lantern Pharma Completes Type C Meeting With FDA, Advancing Pediatric CNS Cancer Trial Including Atypical Teratoid Rhabdoid Tumor

Lantern Pharma Inc. (NASDAQ:LTRN), an AI-driven clinical -stage oncology company developing targeted therapies for cancer that are being advanced using its proprietary computational biology and machine learning platform, today announced the successful completion of a Type C meeting with the U.S. Food and Drug Administration (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 (ATRT).

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 (investigational new drug) 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.

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 (IND) application amendment incorporating the FDA's guidance in the coming months, with planned trial initiation targeted for Q1 2026.