Lantern Pharma Announces Completion of Type C Meeting with FDA, Providing Clarity on Regulatory Pathway for Pediatric CNS Cancer Trial

By: Lantern Pharma Inc. via Business Wire

September 03, 2025 at 09:44 AM EDT

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.

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

About Lantern Pharma:

Lantern Pharma (NASDAQ: LTRN) is an AI company transforming the cost, pace, and timeline of oncology drug discovery and development. Our proprietary AI and machine learning (ML) platform, RADR®, leverages over 200 billion oncology-focused data points and a library of 200+ advanced ML algorithms to help solve billion-dollar, real-world problems in oncology drug development. By harnessing the power of AI and with input from world-class scientific advisors and collaborators, we have accelerated the development of our growing pipeline of therapies that span multiple cancer indications, including both solid tumors and blood cancers and an antibody-drug conjugate (ADC) program. Our lead development programs include a Phase 2 clinical program and multiple Phase 1 clinical trials. Our AI-driven pipeline of innovative product candidates is estimated to have a combined annual market potential of over $15 billion USD and have the potential to provide life-changing therapies to hundreds of thousands of cancer patients across the world.

Please find more information at:

Website: www.lanternpharma.com
LinkedIn: https://www.linkedin.com/company/lanternpharma/
X: @lanternpharma

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