Presentation

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 arfolitixorin aims to increase efficacy and reduce the side effects of antimetabolites used in cancer treatment. The company’s objective is to initially enhance the effect of SoC chemotherapy within metastatic colorectal cancer (mCRC), the third most common cancers type. Isofol holds a worldwide exclusive license agreement with Merck & Cie, Darmstadt, Germany to develop and commercialise arfolitixorin for oncology indications.

Recent highlights
In August, Isofol announced that neither the primary endpoint of Overall Response Rate (ORR) nor the key secondary endpoint in Progression Free Survival (PFS) achieved statistical significance in the multi-center, international Ph3 AGENT Study of arfolitixorin in combination with 5-FU, oxaliplatin and bevacizumab in metastatic colorectal cancer (mCRC). The AGENT Study will be completed in accordance with applicable regulations and the full data set will be published.

Outlook
Following recent announcement of its Ph3 study results, Isofol will complete the data analysis before confirming next steps and look forward to working with regulatory agencies to consider alternative paths forward. Decisions related to Isofol’s clinical programme will be on hold until consultation with relevant regulatory bodies which is tentatively planned during H1 2023.