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Lantern Pharma Inc. (Nasdaq: LTRN), an artificial intelligence-driven biopharmaceutical company, has received clearance from the U.S. Food and Drug Administration (FDA) for a Phase 1b/2 clinical trial to evaluate LP-184 in the treatment of triple negative breast cancer (TNBC). The clearance follows the FDA's Orphan Drug Designation for LP-184 in TNBC in 2023 and Fast Track Designation in 2024 [1].
The clinical trial, which will be conducted at select centers in the United States, India, and Nigeria, aims to assess LP-184's safety and efficacy in recurrent, advanced-stage TNBC patients. The trial will evaluate LP-184 as both a monotherapy and in combination with olaparib, a PARP inhibitor. The primary endpoints of the study include safety and efficacy parameters that could potentially support a pathway to regulatory approval [1].
LP-184 is a synthetically lethal small molecule that induces DNA double-strand breaks upon bioactivation by the enzyme prostaglandin reductase 1 (PTGR1) in cancer cells. Preclinical studies suggest that LP-184 may preferentially respond to cancers with DDR gene alterations, including TNBC [1]. The global TNBC market is estimated at $3-5 billion USD annually, with over 300,000 new cases diagnosed worldwide each year [1].
The strategic design of the clinical trial reflects both the compelling mechanistic rationale and the encouraging data supporting LP-184's potential in TNBC. Lantern Pharma's CEO and President, Panna Sharma, stated, "The strategic design of our clinical program reflects both the compelling mechanistic rationale and the encouraging data supporting LP-184's potential in TNBC" [1].
Lantern Pharma's AI-driven platform, RADR®, leverages over 100 billion oncology-focused data points and a library of 200+ advanced ML algorithms to accelerate drug discovery and development. The company's lead development programs include a Phase 2 clinical program and multiple Phase 1 clinical trials [1].
References:
[1] https://finance.yahoo.com/news/lantern-advances-drug-candidate-lp-125500305.html
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