On November 17, 2025 One-carbon Therapeutics AB, a clinical-stage biotechnology company pioneering a novel cancer therapy, reported that the first subject has been successfully dosed in its ODIN Phase 1/2 clinical trial (NCT07151040) evaluating TH9619, a first-in-class MTHFD1/2 inhibitor.

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This milestone was achieved at START Madrid/Fundación Jiménez Díaz University Hospital, under the supervision of Dr. Victor Moreno, Director of Clinical Research and Principal Investigator. Dr. Moreno commented: "I am pleased that 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, and we look forward to continuing collaborating with One-carbon Therapeutics."

"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, Chief Executive Officer of One-carbon Therapeutics. "TH9619 embodies our unique strategy of targeting one-carbon metabolism proteins, by killing cancer cells while sparing normal cells and bringing new hope to subjects with high unmet medical need. We are deeply grateful to the investigators, clinical teams, our collaborators, and most importantly, the subjects who make this progress possible."

About TH9619

TH9619 is a first-in-class, potent, small-molecule, and a dual inhibitor of MTHFD1/2, highly overexpressed and cancer-specific enzymes within the one-carbon metabolic pathway – TH9619 kills cancer cells via a dual mechanism of action (1) inhibition of MTHFD1 traps folate leading to thymidine depletion (2) inhibition of nuclear MTHFD2 disrupts DNA damage response and repair pathways. With its unique characteristics, TH9619 kills tumor cells, while sparing healthy tissue.

About ODIN Phase 1/2 Clinical Study

This is a first in human, multicenter, open label, dose escalation and expansion study, aiming at evaluating safety, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of TH9619 as monotherapy in subjects with advanced refractory solid tumors, including colorectal cancer, non-small cell lung cancer, head & neck squamous cell carcinoma, gastric cancer or gastroesophageal junction cancer. The trial is currently being conducted across leading academic and clinical research centers in the United Kingdom, France, and Spain, with expansion planned across additional European sites in the coming months.

Clinicaltrials.gov NCT07151040; EudraCT No. 2024-519639-40-00

(Press release, One-carbon Therapeutics, NOV 17, 2025, View Source [SID1234661124])