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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

Lantern Pharma's Investigational Drug-Candidate, LP-184, Receives Second Fast Track Designation From FDA For Treatment Of Triple Negative Breast Cancer

Lantern pharma的研发药物候选人LP-184获得FDA针对三阴性乳腺癌治疗的第二次快速通道认证
Benzinga ·  12/03 21:12
  • 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 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.
  • LP-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.
  • Fast Track Designation is designed to expedite FDA review of important new drugs to treat serious conditions and fill an unmet medical need.
  • LP-184 is currently being evaluated in a Phase 1A clinical trial (NCT05933265) across multiple solid tumor indications, including TNBC.
  • 这是LP-184在2024年获得的第二个快速通道设计,之前是因为在2024年10月宣布的对于Glioblastoma(GBM)的指定。
  • LP-184的快速通道指定认可TNBC为一个严重的疾病,每年影响美国约29,000名患者,其中超过50%的患者在3-5年内出现复发。
  • LP-184已在TNBC模型中展示出显著的临床前功效,包括对PARP抑制剂有抵抗性的模型,并最近的数据显示了与TNBC中的检查点抑制剂有希望的协同作用。
  • 快速通道认定旨在加速FDA审查治疗严重疾病的重要新药物,满足医疗需求。
  • LP-184目前正在进行一项Phase 1A临床试验(NCT05933265),涵盖多种固体肿瘤指征,包括TNBC。

Lantern 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.

Lantern Pharma Inc.(纳斯达克:LTRN)是一家致力于开发癌症治疗方案、改变肿瘤药物发现和研发的成本、速度和时间表的人工智能(AI)公司。该公司今天宣布,FDA已为研究药物候选LP-184在治疗三阴性乳腺癌(TNBC)方面授予快速通道指定。这标志着LP-184在2024年获得的第二个快速通道指定,之前是因为在10月份对Glioblastoma的指定。

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