About Isofol and arfolitixorin (Modufolin®)
Isofol Medical AB was founded in 2008 based on the research of Professor Bengt Gustavsson and his collaboration with Merck & Cie, the world’s leading manufacturer of folate-based therapies. Isofol’s main objective is to improve the outlook for the majority of cancer patients undergoing chemotherapy treatments.
Isofol’s clinical lead candidate is arfolitixorin (Modufolin®), a novel folate-based therapy developed to increase the efficacy and reduce the side effects of antimetabolites used in cancer treatment. It is the key active metabolite of all clinically used folate-based drugs today, including leucovorin and levoleucovorin, and therefore does not require metabolic activation to exert its action. All current folate-based therapies used in cancer treatment are prodrugs that need multiple activation steps into an active metabolite to exert their actions. Isofol has shown that a few genes determine cancer patients’ ability to activate these prodrugs. By purifying the key active metabolite of all the marketed folate-based prodrugs, Isofol has created a product that does not require metabolic activation to exert its action.
A majority of all patients treated for colorectal cancer with chemotherapy are also treated with folate-based therapies, and the combination of chemotherapy with folates is the most commonly used cancer treatment in the world. The market opportunity for arfolitixorin (Modufolin®) may therefore be measured in billions of US$. Isofol is now conducting combined phase I and II clinical trials to verify the benefits ofarfolitixorin (Modufolin®) as a co-therapy in the treatment of cancer. To date, arfolitixorin (Modufolin®) has been shown to be safe after treating numerous patients and Isofol is to commence the ISO-CC-007 study to prove the efficacy of arfolitixorin (Modufolin®) in colorectal cancer patients.
Isofol intends to take arfolitixorin (Modufolin®) to market registration through a couple of clinical trials. Isofol will then follow the most favourable strategy to commercialise arfolitixorin (Modufolin®) worldwide. To help achieve this, Isofol collaborates with a number of companies:
- Isofol has a strategic R&D partnership with Merck & Cie, an affiliate of Merck KGaA, a leading science and technology company in healthcare, life science and performance materials and the world’s leading supplier of reduced folates such as Metafolin®and Leucovorin. Isofol holds an exclusive supply and license agreement for arfolitixorin (Modufolin®) from Merck & Cie.
- A collaboration is in place with Recipharm for the exclusive commercial manufacture of arfolitixorin (Modufolin®). Recipharm is a leading European CDMO (Contract Development and Manufacturing Organization) in the pharmaceutical industry.
- Sahlgrenska University Hospital is an important clinical development platform for Isofol as it provides key clinical and medical competence to the company as well as offering state of the art facilities for Isofol’s clinical trials.
Isofol has had successful meetings with regulatory authorities in Sweden, the US and Europe
In 2015, a meeting with the Swedish Medical Products Agency indicated that arfolitixorin (Modufolin®) could be eligible for market approval if a clinical superiority program would be completed. Isofol met with both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) during 2016. Both agencies endorsed the clinical development plan for arfolitixorin (Modufolin®), and were in agreement with Isofol regarding the requirements for the registration of arfolitixorin (Modufolin®). Isofol’s development plan aims for the completion of a proof-of-superiority program in 2020/2021.