Presentation

Company Profile
Isofol Medical is a clinical-stage biotech company founded in 2008 in Gothenburg, Sweden. The firm was born through the research of Professor Bengt Gustavsson and his collaboration with Merck & Cie, the leading manufacturer of folate-based therapies. Isofol’s lead candidate is a novel folate-based therapy named arfolitixorin, which aims to increase efficacy and reduce the side effects of antimetabolites used in cancer treatment. The firm's objective is to initially enhance the effect of SoC chemotherapy within metastatic colorectal cancer (mCRC), one of the most common cancers. The Ph3 pivotal trial AGENT is aiming to show superiority versus SoC. Isofol has signed licensing agreement for arfolitixorin covering Japan and Canada.

Recent highlights
In the interim analysis after 330 patients, conducted in March, the IDSMB recommended that the AGENT study continues according to the original protocol with 440 patients. Q2 was eventful for the company; it completed recruitment of the Japanese arm of the Phase III AGENT study, raised SEK 450m and was subject to yet another successful interim safety analysis by the iDSMB.

Outlook
With more than SEK 500m in its coffers, Isofol is now focusing on pre-commercialization activities awaiting the top-line results from the AGENT study. The study is event-driven, and the cut-off is 300 PFS events. Top-line results are expected in H1 2022.