Clinical-stage, AI-native biopharma company Lantern Pharma Inc (NASDAQ:LTRN) said on Tuesday that the European Medicines Agency (EMA) has cleared an investigator-initiated Phase 1b/2 clinical trial of LP-184 (zirdafulven) in patients with advanced, recurrent bladder cancer who have exhausted or are ineligible for standard therapies.

The study will be conducted at Rigshospitalet in Copenhagen in collaboration with Professor Helle Pappot and will evaluate a dual-biomarker precision oncology strategy combining PTGR1 overexpression with tumour DNA-damage repair deficiency. The trial is among the first to prospectively select patients using both PTGR1 overexpression and nucleotide excision repair deficiency to identify tumours most likely to respond to LP-184.

Lantern plans to position LP-184 initially as a third-line treatment for advanced metastatic bladder cancer, targeting an estimated global patient population of approximately 137,500 annually, with the company estimating a market opportunity exceeding USD3bn by 2035.

The open-label study will enrol up to approximately 39 patients and will assess objective response rate as the primary endpoint, alongside progression-free survival, overall survival, duration of response, quality of life and biomarker correlations.

Lantern said no FDA-approved therapy currently exists for nucleotide excision repair-deficient tumours, while approximately 20% to 25% of bladder cancer cases progress to third-line treatment.