Lantern Pharma FDA Meeting and Pediatric CNS Cancer Trial FAQ

What is the main announcement from Lantern Pharma?

Lantern Pharma completed a Type C meeting with the FDA and received guidance on the regulatory pathway and design for a planned pediatric trial targeting CNS cancers, including Atypical Teratoid Rhabdoid Tumor (ATRT).

What specific support did the FDA provide for the trial?

The FDA supported Lantern’s proposal for a parallel ATRT cohort and the potential inclusion of spironolactone as a combination agent with LP-184/STAR-001, the company’s lead investigational therapy.

When is the trial expected to begin?

Trial initiation is targeted for Q1 2026, following submission of an IND amendment reflecting the FDA feedback.

What designations does this program hold?

The program holds Rare Pediatric Disease and Orphan Drug designations from the FDA.

What outcomes will the multi-site study focus on?

The study will focus on progression-free survival, overall response rate, and quality-of-life outcomes for pediatric CNS cancer patients.

Who is conducting this trial?

Lantern Pharma, through its subsidiary Starlight Therapeutics, will conduct the trial, which is an AI-driven clinical-stage oncology company.

What is Lantern Pharma’s AI platform called?

Lantern Pharma uses RADR®, a proprietary AI and machine learning platform that leverages over 200 billion oncology-focused data points and 200+ advanced ML algorithms.

What is the market potential of Lantern Pharma’s pipeline?

The company’s AI-driven pipeline of innovative product candidates is estimated to have a combined annual market potential of over $15 billion USD.

Where can investors find the latest news and updates about Lantern Pharma?

The latest news and updates relating to LTRN are available in the company’s newsroom at https://ibn.fm/LTRN.