Lantern Pharma (NASDAQ: LTRN), an AI-native precision oncology company, announced that the European Medicines Agency (EMA) has cleared an investigator-initiated Phase 1b/2 clinical trial evaluating its lead drug candidate LP-184 (zirdafulven) in patients with advanced or metastatic bladder cancer. The biomarker-guided study will be conducted at Rigshospitalet in Copenhagen, Denmark, and will enroll up to 39 patients. Participants will be prospectively selected based on PTGR1 overexpression and DNA-damage-repair deficiency, a strategy that leverages Lantern's proprietary RADR platform to identify patients most likely to benefit.
The trial will evaluate LP-184 in patients who have progressed on or are ineligible for current standard-of-care therapies, addressing a significant unmet need in bladder cancer treatment. Bladder cancer is one of the most common cancers worldwide, and advanced stages often have limited treatment options after first-line therapies fail. By focusing on biomarker-driven patient selection, Lantern aims to improve clinical outcomes and demonstrate the power of its AI-driven approach.
LP-184 is an acylfulvene that has shown preclinical activity in tumors with defects in DNA damage repair pathways. The EMA clearance marks a critical milestone for Lantern, as it expands the clinical development of LP-184 beyond ongoing studies in the United States. The company is also developing LP-184 for pediatric CNS cancers through its wholly owned subsidiary Starlight Therapeutics.
Lantern's proprietary RADR platform uses artificial intelligence and machine learning to analyze genomic data and predict drug responses. This trial's biomarker-guided design exemplifies how the platform can be used to optimize clinical development. Additionally, Lantern's withZeta.ai platform, a multi-agentic AI co-scientist, is now commercially available as a subscription-based research platform, representing a new revenue stream for the company.
The clearance by the EMA is a significant regulatory step, allowing Lantern to advance its clinical pipeline in Europe. The company operates an AI Center of Excellence in Bengaluru, India, and is headquartered in Dallas, Texas. For more information, visit the company's newsroom at https://ibn.fm/LTRN.
