One-carbon Therapeutics starts new cancer therapy trial

Esme Needham | November 27, 2025 | News story | Research and Development Oncology, One-carbon Therapeutics 

Clinical-stage biotechnology company One-carbon Therapeutics has announced that the first subject has been dosed in its clinical trial for TH9619, a drug treatment that kills tumour cells while avoiding healthy tissues.

The ODIN phase 1/2 clinical trial is testing the potential of TH9619, a first-in-class MTHFD1/2 inhibitor, as a potential therapy for patients with advanced solid tumours. The unique tumour-cell-targeting features of TH9619 means it also has potential as a treatment with fewer harmful side-effects.

The trial is currently being conducted across research centres in the UK, France and Spain, and is expected to expand to other European testing sites. Cancers that could potentially be treated with the new therapy include colorectal cancer, non-small cell lung cancer, head & neck squamous cell carcinoma, gastric cancer and gastroesophageal junction cancer.

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The first patient was dosed at the START Madrid unit at the Fundación Jiménez Díaz University Hospital in Madrid. Victor Moreno, director of clinical research and principal investigator, who oversaw the first dose, commented: “Our subjects now have access to next-generation investigational therapies such as TH9619. This study opens new possibilities for cancer treatments where options remain limited.”

“Dosing the first subject in our ODIN study represents a significant step in turning our cutting-edge science into first-in-class therapies,” said Ana Slipicevic, CEO at One-carbon. “TH9619 embodies our unique strategy of targeting one-carbon metabolism proteins, killing cancer cells while sparing normal cells and bringing new hope to subjects with high unmet medical need.”

Headquartered in Sweden, One-carbon Therapeutics AB focuses on researching and developing novel cancer therapies. Its primary focus is MTHFD1/2 inhibitor therapies, which it has presented at summits across Europe.

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