Isofol’s drug candidate arfolitixorin receives additional clinical patent approval in US

Isofol Medical AB (publ), a clinical stage biotech company, announced approval of a clinical patent for arfolitixorin in the United States. The patent expires in 2038 and is a divisional patent for the master patent granted in the US in May 2019.

The now granted patent (US 10,639,311) is more specifically focused on the dose regimen used in the ongoing clinical AGENT study.

This regime has shown superior effectiveness of reducing tumor growth compared to leucovorin and 5-fluorouracil. This better effect is due to a stronger inhibition of Thymidylate Synthase (TS), a vital enzyme for the DNA synthesis and tumor growth, which can be simply measured as the increased level of the biomarker deoxyuridine in blood samples from patients. The master patent refers to the way to increase the blood concentration of deoxyuridine, a blood biomarker that indicates inhibition of tumor growth in the treatment of cancer patients.

Ulf Jungnelius, CEO of Isofol commented, “This patent is considered of particular importance for Isofol. It is a clinical patent that mirror the ongoing global phase 3 study AGENT with arfolitixorin demonstrating potential superior activity for arfolitixorin and 5-fluorouracil treatment compared to today’s standard of care therapy with leucovorin and 5-fluorouracil.”

Arfolitixorin is Isofol’s proprietary drug candidate being developed to increase the efficacy of standard of care chemotherapy for advanced colorectal cancer. The drug candidate is currently being studied in a global phase 3 study, AGENT. As the key active metabolite of the widely used folate-based drugs, arfolitixorin can potentially benefit all patients with advanced colorectal cancer, as it does not require complicated metabolic activation to become effective.