Lantern Pharma Advances Pediatric Brain Cancer Trial Following FDA Guidance

Lantern Pharma is advancing clinical development of its investigational therapy LP-184/STAR-001 for treating rare pediatric central nervous system cancers following constructive guidance from the U.S. Food and Drug Administration. The company is preparing to launch a clinical trial targeting Atypical Teratoid Rhabdoid Tumor in the first quarter of 2026, building on recent regulatory progress and design validation from FDA discussions.

The therapy represents a novel approach to treating devastating childhood brain cancers, with LP-184/STAR-001 designed to work synergistically with diuretic spironolactone and other potential combination regimens. This development pathway has been strengthened by the FDA's Rare Pediatric Disease Designation and Orphan Drug Designation granted to Lantern's ATRT program, providing important regulatory advantages for addressing this unmet medical need.

Company leadership emphasized the significance of the FDA feedback in validating both the trial design and the underlying artificial intelligence platform driving drug development. Lantern President and CEO Panna Sharma noted that the guidance reinforces the potential of their AI platform, RADR®, in identifying and optimizing combination regimens for pediatric CNS cancers. The company is now preparing to submit an investigational new drug amendment to advance the program toward clinical testing.

Lantern's approach leverages computational biology and machine learning through its proprietary RADR® platform, which utilizes over 200 billion oncology-focused data points and more than 200 advanced machine learning algorithms. This AI-driven methodology has enabled the company to accelerate drug development timelines significantly, with programs typically advancing from initial AI insights to first-in-human clinical trials in just 2-3 years at approximately $2.5 million per program according to company information available at https://ibn.fm/LTRN.

The upcoming trial represents an important milestone in applying artificial intelligence to oncology drug development, particularly for rare pediatric conditions where traditional development approaches have often proven challenging. The combination of AI-optimized drug candidates with established medications like spironolactone could potentially open new treatment avenues for children facing limited options for CNS cancers.