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Lantern Pharma Announces Three U.S. FDA Rare Pediatric Disease Designations Granted to LP-184 in Multiple Ultra Rare Children’s Cancers
Lantern Pharma was granted the rare pediatric disease designation (RPDD) for drug-candidate, LP-184, in three cancer indications: Malignant Rhabdoid Tumors,
About this update from Lantern Pharma Inc.
[{"type":"text","content":"\n\nLantern Pharma was granted the rare pediatric disease designation (RPDD) for drug-candidate, LP-184, in three cancer indications: Malignant Rhabdoid Tumors, Rhabdomyosarcoma, and Hepatoblastoma.\n\n\n\nThis brings the total number of RPDDs for LP-184 to 4, including one previously granted for ATRT (Atypical Teratoid Rhabdoid Tumors).\n\n\n\nEfficacy of LP-184 in these three rare pediatric cancers was demonstrated through evidence of tumor regression and extended event-free survival in specialized models developed as part of the Pediatric Preclinical Testing Program (PPTP), an initiative supported by the National Cancer Institute (NCI) to identify novel therapeutic agents that may have significant activity against childhood cancers.\n\n\n\nCompanies with RPDDs might be eligible to receive a Priority Review Voucher (PRV) upon FDA marketing approval that could be redeemed to receive a priority review for any subsequent marketing application. If received, PRVs may be used by the sponsor or sold to another sponsor and have recently sold for over $100 million(1).\n\n\n DALLAS--(BUSINESS WIRE)--\nLantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence (“AI”) company developing targeted and transformative cancer therapies using its proprietary RADR® AI and machine learning (“ML”) platform with multiple clinical-stage drug programs, announced today that the company has been granted three rare pediatric disease designations (RPDD) by the FDA. Lantern was granted these rare pediatric disease designations in: malignant rhabdoid tumors (MRT), rhabdomyosarcoma (RMS), and hepatoblastoma.\n\n\"At Lantern, we're harnessing AI and data-driven approaches to revolutionize cancer drug development, aiming to dramatically reduce costs, accelerate timelines, and enhance precision in bringing new therapies to patients,\" stated Panna Sharma, CEO and President of Lantern Pharma. \"Our recent breakthrough in identifying three additional, high-potential indications for LP-184 in pediatric cancers exemplifies this progress. We believe that 'AI for good' should address both blockbuster opportunities as well as rare, often overlooked pediatric cases. The FDA's Rare Pediatric Disease designation for these three potential programs is a testament to this commitment. We're acutely aware that patients and their families are relying on innovators like us...