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Lantern Pharma's Investigational Drug-Candidate, LP-184, Receives Second Fast Track Designation from FDA for Treatment of Triple Negative Breast Cancer (TNBC)
This is the second Fast Track Designation granted to LP-184 in 2024, following the designation for Glioblastoma (GBM) announced in October 2024. Fast Track
About this update from Lantern Pharma Inc.
[{"type":"text","content":"\n\nThis is the second Fast Track Designation granted to LP-184 in 2024, following the designation for Glioblastoma (GBM) announced in October 2024.\n\n\n\nFast Track Designation for LP-184 recognizes TNBC as a serious condition impacting approximately 29,000 patients annually in the US, with over 50% of patients relapsing within 3-5 years.\n\n\n\nLP-184 has demonstrated significant preclinical efficacy in TNBC models, including those resistant to PARP inhibitors, and recent data shows promising synergy with checkpoint inhibitors in TNBC.\n\n\n\nFast Track Designation is designed to expedite FDA review of important new drugs to treat serious conditions and fill an unmet medical need.\n\n\n\nLP-184 is currently being evaluated in a Phase 1A clinical trial (NCT05933265) across multiple solid tumor indications, including TNBC.\n\n\n\n DALLAS--(BUSINESS WIRE)--\nLantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence (AI) company dedicated to developing cancer therapies and transforming the cost, pace, and timeline of oncology drug discovery and development, today announced that the FDA has granted Fast Track Designation for investigational drug candidate, LP-184, for treatment of Triple Negative Breast Cancer (TNBC). This marks the second Fast Track Designation received for LP-184 in 2024, following its designation for Glioblastoma in October.\n\nThis press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20241203997484/en/LP-184 demonstrated tumor regression of 107-141% in multiple TNBC PDX models. (Graphic: Business Wire)\nLP-184 is currently in a Phase 1A clinical trial designed to evaluate the safety and tolerability of this synthetically lethal investigational drug candidate in a broad range of solid tumors, including TNBC. LP-184 was optimized and advanced in part with Lantern's AI platform, RADR®, which helped validate mechanisms that could be exploited in the clinical setting to eradicate challenging cancers and uncover insights in targeted patient populations.\n\n\n\"Receiving a second FDA Fast Track Designation for LP-184 reinforces the significant potential of this drug candidate to address critical unmet needs in aggressive cancers, especially those like TNBC where patients have limited therapeutics options,\" stated Panna Sharma, President and CEO of Lantern Pharma....