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Lantern Pharma Receives Clearance Of IND Application From FDA For Phase 1b/2 Clinical Trial For LP-184 In Triple Negative Breast Cancer

Benzinga·05/05/2025 12:57:09
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  • The FDA has cleared the investigational new drug (IND) application of LP-184 in triple negative breast cancer (TNBC) treatment – a novel small molecule advanced and developed with Lantern's AI platform, RADR®
  • The phase 1b/2 clinical trial plans to evaluate LP-184 in recurrent TNBC patients as both monotherapy and in combination with olaparib.
  • This achievement follows the FDA's Orphan Drug Designation for LP-184 in TNBC in 2023 and FDA Fast Track Designation for LP-184 in TNBC in 2024.
  • The average survival for newly diagnosed, metastatic TNBC is estimated at 18 months and presents an annual market opportunity in excess of $4 billion USD. 

Lantern Pharma Inc. (NASDAQ:LTRN), an artificial intelligence company developing targeted and transformative cancer therapies using its proprietary AI platform, RADR®, today announced that it has received clearance of its Investigational New Drug Application (IND) from the U.S. Food and Drug Administration (FDA) for a Phase 1b/2 clinical trial for LP-184 in Triple Negative Breast Cancer. This achievement builds on the previous regulatory momentum including Orphan Drug Designation in 2023 and Fast Track Designation in 2024.