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Lantern Pharma and Starlight Therapeutics Announce FDA Clearance of IND for a Planned Phase 1 Pediatric CNS Cancer Trial of STAR-001

LTRN
  • Lantern Pharma Inc. & its subsidiary Starlight Therapeutics received FDA clearance for an Investigational New Drug (IND) application for STAR-001 in a planned Phase 1 pediatric clinical trial (IND No. 179145).
  • The trial will evaluate STAR-001 as a monotherapy and in combination with spironolactone in pediatric patients with relapsed or refractory central nervous system (CNS) malignancies.
  • Targeted cancer types include Atypical Teratoid/Rhabdoid Tumor (ATRT), Diffuse Intrinsic Pontine Glioma (DIPG), Glioblastoma (GBM), Medulloblastoma, and Ependymoma.
  • The study is a multicenter, open-label, dose escalation trial conducted in collaboration with POETIC, a network of 14 leading academic children's cancer centers across the U.S., Canada, and Israel.
  • Enrollment is planned for approximately 18 to 42 pediatric patients aged 1 to 17 years across approximately 15 academic centers.
  • STAR-001 is a precision oncology compound developed using Lantern's proprietary RADR® AI platform, which identified PTGR1 overexpression as a key vulnerability in pediatric CNS tumors.
  • The combination strategy exploits synthetic lethality: spironolactone degrades the ERCC3 DNA repair enzyme, while STAR-001 induces DNA damage that cannot be repaired in the absence of ERCC3.
  • Preclinical data showed the combination extended median survival by 181% in ATRT orthotopic xenograft models compared to control.
  • Lantern Pharma holds FDA Rare Pediatric Disease Designation for STAR-001 in the treatment of ATRT.
  • The trial aims to assess safety, tolerability, and preliminary activity of the therapy, with initiation subject to obtaining additional funding.