- Poster presentation (TPS3165) of the ODIN Phase 1/2 first-in-human study of TH9619, a first-in-class dual MTHFD1/2 inhibitor, in subjects with advanced refractory solid tumours
- Study actively enrolling across leading clinical research centres in the United Kingdom, France, and Spain, with European expansion ongoing
- Trial-in-Progress poster to be presented on Saturday, May 30th, 2026, 1:30–4:30 PM CDT, Board 297A
Solna, Sweden, May 29th, 2026. One-carbon Therapeutics AB, a clinical-stage biotechnology company pioneering first-in-class cancer therapies that exploit cancer’s oncogene addition, today announced that a Trial-in-Progress poster on its ongoing ODIN Phase 1/2 clinical study (NCT07151040) of TH9619 will be presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from May 29th to June 2nd in Chicago, Illinois.
Presentation details: Abstract TPS3165 — “A Phase 1/2 First-in-Human Study of TH9619 in Patients with Advanced Refractory Solid Tumours (ODIN)” will be presented by Dr. Victor Moreno (START Madrid–FJD, Hospital Fundación Jiménez Díaz, Madrid, Spain) during the Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology poster session on Saturday, May 30th , 2026, from 1:30 to 4:30PM CDT (Board 297A).
TH9619 is a first-in-class potent small molecule MTHFD1/2 inhibitor that selectively kills cancer through folate trapping. In cancer cells, high MTHFD2 expression drives the release of formate from mitochondria into the cytosol, to generate 10-CHO-THF (formylfolate). Inhibition of MTHFD1 by TH9619 prevents further use of 10-CHO-THF for downstream thymidylate synthesis. This creates a folate trap, depleting the folate (THF) necessary for thymidylate production, resulting in nucleotide shortage, DNA damage, and cancer cell death. Normal cells lack MTHFD2 expression, and the formate overflow needed to create this trap.
ODIN (NCT07151040; EudraCT No. 2024-519639-40-00) is a first-in-human, multicentre, open-label, Phase 1/2 study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumour activity of TH9619 as monotherapy in adult subjects with advanced colorectal cancer, non–small cell lung cancer, head and neck squamous cell carcinoma, gastric cancer, or gastroesophageal junction cancer who have exhausted standard-of-care options. The Phase 1a dose-escalation part is actively enrolling across leading academic and clinical research centres in the United Kingdom, France, and Spain, with expansion planned across additional European sites in the coming months.
“We are pleased to share the rationale and design of the ODIN Phase 1/2 study with the global oncology community at ASCO. This Trial-in-Progress poster presentation reflects the careful translation of years of preclinical research into a clinical programme aimed at a clear and pressing unmet need. Dose escalation is progressing as planned, and we look forward to generating the safety, pharmacokinetic and early activity data that will inform the path forward for TH9619 in subjects with advanced refractory solid tumours,” said Eva Ehrnrooth, Chief Medical Officer of One-carbon Therapeutics and co-author of the presentation.
The poster will be made available on the One-carbon Therapeutics website (https://one-carbon.com/) following its presentation at the meeting.
About One-carbon Therapeutics
One-carbon Therapeutics AB is a clinical-stage biotechnology company pioneering novel anti-cancer therapies. Based on the strong preclinical data for TH9619 — first-in-class, potent, small molecule and dual inhibitor of MTHFD1/2 — One-carbon Therapeutics is targeting difficult to treat advanced refractory solid tumors. The company is headquartered in Sweden and is committed to translating cutting-edge metabolic science into transformative clinical impact for subjects worldwide. For more information, please visit https://one-carbon.com/.
