Starlight Therapeutics’ wholly owned subsidiary Lantern Pharma has secured the US Food and Drug Administration (FDA) clearance for its investigational new drug (IND) application to initiate a Phase I paediatric central nervous system (CNS) cancer trial of STAR-001.
The dose-escalation, open-label, multi-centre trial will assess STAR-001 in combination with spironolactone for relapsed or refractory CNS malignancies.
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STAR-001, identified for CNS and paediatric CNS indications by Lantern’s RADR AI platform, will be studied as both a single agent and with spironolactone.
Lantern will collaborate with the Pediatric Oncology Experimental Therapeutics Investigators’ Consortium (POETIC), a network of 14 academic centres in Canada, Israel, and the US.
The trial covers several high-grade paediatric CNS tumours, including diffuse intrinsic pontine glioma (DIPG), atypical teratoid / rhabdoid tumour (ATRT), medulloblastoma, ependymoma, and glioblastoma. Lantern holds a rare paediatric disease designation from the FDA for ATRT.
It intends to recruit 18 to 42 patients aged one to 17 years and will be carried out at nearly 15 academic centres in Canada, Israel, and the US via POETIC’s international network. Additional funding is required before commencement.
The combination arm of the study leverages AI-driven identification of excision repair cross-complementation group 3 (ERCC3) as a therapeutic target in high-grade tumours.
Lantern Pharma CEO and Starlight Therapeutics founder Panna Sharma said: “This IND clearance is a defining milestone for Starlight Therapeutics and a meaningful step forward for paediatric neuro-oncology. For children with relapsed or refractory CNS tumours, the options are desperately limited — and the science behind this planned trial was built to change that.
“In ATRT models, the combination extended median survival by 181% compared to the control. We believe this represents a genuinely new way to attack these brain cancers, and we are proud to be advancing it through a network of some of the world’s most respected paediatric oncology centres.”
Last year, Lantern Pharma completed targeted enrolment for its multi-centre Phase II HARMONIC clinical trial of a disulfide small molecule, LP-300, in Japan for the treatment of non-small cell lung cancer (NSCLC).
