Lantern Pharma Completes FDA Type C Meeting for Pediatric CNS Cancer Trial

Lantern Pharma, a company using artificial intelligence (AI) in cancer therapy development, has completed a Type C meeting with the FDA regarding its pediatric CNS cancer trial. The meeting focused on the clinical execution of its therapies for CNS and brain cancers through Starlight Therapeutics Inc. Lantern Pharma's RADR AI and machine learning platform leverages over 60 billion oncology-focused data points to develop targeted and transformative cancer therapies.

Lantern Pharma Inc. (NASDAQ: LTRN), a leading AI-driven clinical-stage oncology company, has completed a Type C meeting with the U.S. Food and Drug Administration (FDA) to discuss its pediatric CNS cancer trial. The meeting provided critical guidance on the regulatory pathway and trial design, focusing on CNS and brain cancers through its subsidiary, Starlight Therapeutics Inc. Lantern Pharma's proprietary RADR AI and machine learning platform, which leverages over 60 billion oncology-focused data points, played a pivotal role in developing targeted and transformative cancer therapies [1].

During the Type C meeting, the FDA provided constructive feedback on the proposed clinical trial structure, which includes a parallel cohort specifically for Atypical Teratoid Rhabdoid Tumor (ATRT) patients to accelerate data collection in this ultra-rare population. The agency also confirmed the potential incorporation of spironolactone as a combination agent to assess its 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 [2].

Lantern Pharma'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 company is now preparing to submit an IND (investigational new drug) application amendment for LP-184/STAR-001 under Starlight Therapeutics, based on the guidance and dialogue from the Type C meeting. Lantern Pharma plans to initiate the trial in Q1 2026 [1].

References:
[1] https://www.morningstar.com/news/business-wire/20250903320377/lantern-pharma-announces-completion-of-type-c-meeting-with-fda-providing-clarity-on-regulatory-pathway-for-pediatric-cns-cancer-trial
[2] https://www.stocktitan.net/news/LTRN/lantern-pharma-announces-completion-of-type-c-meeting-with-fda-xgm2vqy14ew0.html