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 study, to be conducted at Rigshospitalet in Copenhagen, Denmark, will enroll up to 39 patients and prospectively select participants based on PTGR1 overexpression and DNA-damage-repair deficiency.
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 among the most common cancers worldwide, and advanced stages often become resistant to available treatments. By using a biomarker-guided approach, Lantern aims to identify patients most likely to benefit from LP-184, potentially improving outcomes and reducing unnecessary side effects.
This announcement further advances Lantern's AI-driven precision oncology strategy through its proprietary RADR® platform, which leverages artificial intelligence and machine learning to optimize drug development. The company's clinical pipeline includes LP-184 (acylfulvene), LP-284 (a TC-NER targeting compound in hematologic and solid tumors), and LP-300 (cisplatin/ethacraplatin analog), which is being evaluated in the HARMONIC Phase 2 trial in never-smoker patients with relapsed advanced lung adenocarcinoma following TKI treatment. LP-184 is also being developed for pediatric CNS cancers through Starlight Therapeutics, Lantern's wholly owned CNS-focused subsidiary.
Additionally, Lantern has introduced withZeta.ai, its multi-agentic AI co-scientist platform, now commercially available as a subscription-based research platform for the global biomedical and drug development community. This represents a new revenue stream for the company, which operates an AI Center of Excellence in Bengaluru, India and is headquartered in Dallas, Texas.
The EMA clearance marks a critical step for LP-184, potentially expanding treatment options for bladder cancer patients with limited alternatives. If successful, the trial could validate the use of AI-guided biomarker selection in oncology, influencing future drug development strategies. For the industry, this highlights the growing role of precision medicine and AI in accelerating clinical trials and personalizing cancer care.
For more information, visit the company’s newsroom at https://ibn.fm/LTRN and the full press release at https://ibn.fm/6ku4F.
