Lantern Pharma Inc. (Nasdaq: LTRN) said it plans to launch a clinical trial in early 2026 for a rare pediatric brain cancer, following what it called an “optimistic meeting” with the U.S. Food and Drug Administration.

In an announcement, the Dallas-based biotech said the planned Phase 1b/2 trial will evaluate its drug candidate LP-184/STAR-001 in children with central nervous system cancers, including atypical teratoid rhabdoid tumors—a fast-growing brain tumor that primarily affects young children.

The therapy is designed to be used in combination with spironolactone, a diuretic already approved to treat other conditions.

Lantern said it received FDA Rare Pediatric Disease and Orphan Drug designations for its ATRT program and is now preparing to submit an amendment to its investigational new drug (IND) application.

Lantern Pharma CEO Panna Sharma

“We are thrilled with the constructive dialogue and positive feedback from our Type C meeting with the FDA,” Lantern CEO Panna Sharma said in a statement. “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.”

Lantern uses artificial intelligence to identify biomarkers and potential treatment combinations across a range of cancers. Its RADR platform analyzes large genomic datasets to surface genetic variations linked to specific cancers, with the goal of accelerating oncology drug development.

The company said the upcoming pediatric trial will enroll patients across multiple sites. Primary endpoints will focus on progression-free survival, overall response rate, and quality-of-life measures.

While LP-184 is being advanced for pediatric use, it is also part of Lantern’s broader clinical pipeline. The compound is currently in a Phase 1a trial for glioblastoma and advanced solid tumors, including triple-negative breast cancer.

Lantern is also testing LP-300 in a Phase 2 study for non-small cell lung cancer in non-smokers. One patient, a 70-year-old with advanced NSCLC who had failed three prior treatments, recently achieved a complete response after receiving LP-300 in combination with chemotherapy, according to the company.

Another drug candidate, LP-284, is in a Phase 1 trial for relapsed or refractory non-Hodgkin’s lymphoma and other tumors.

“This quarter we observed complete responses in patients across two of our clinical trials, delivering meaningful patient benefit and providing further validation of both the mechanisms and therapeutic potential of our drug candidates,” Sharma said. “Simultaneously, our team is transforming our AI platform into functional, accessible modules for the broader oncology community.”

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