About Modufolin

What is Modufolin?

MODUFOLIN® CONTAINS THE KEY ACTIVE METABOLITE OF ALL CLINICALLY USED FOLATE-BASED DRUGS

Modufolin® is Isofol’s clinical lead candidate, a novel folate-based therapy developed to increase the efficacy and reduce the side effects of antimetabolites used in cancer treatment. The active pharmaceutical ingredient (API) of Modufolin® is the key active metabolite of all clinically used folate-based drugs today, including leucovorin and levoleucovorin, and does therefore not require metabolic activation to exert its action. As part of their cancer treatments, more than 500 000 patients are treated with folate-based therapies annually, in the US, Europe and Japan – more than any other single cancer drug.

UNMET CLINICAL NEED

A MAJORITY OF PATIENTS DO NOT FULLY BENEFIT FROM THEIR FOLATE-BASED THERAPIES TODAY

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. Against this background, Modufolin® may be beneficial regardless of the patient’s genetic ability to activate folates and thus holds the potential to replace the folates used in cancer treatment today.

MULTIPLE METABOLIC STEPS REQUIRED TO CONVERT LEUCOVORIN

MODUFOLIN® INCLUDES THE ACTIVE METABOLITE OF ALL FOLATE-BASED THERAPIES

COLLABORATORS

MODUFOLIN® – INNOVATION THROUGH COLLABORATION

It was not until 2005 that the active ingredient of Modufolin® could be commercially manufactured when Merck & Cie developed and patented a production method. Isofol collaborates closely with Merck & Cie, who are the world’s leading manufacturer of reduced folates. Isofol has a worldwide, exclusive and sub-licensable supply and license agreement for Modufolin® in oncology. The GMP production process for Modufolin® is patent protected and has been validated. Recipharm produced the first large-scale technical GMP batch for Isofol in October, 2016.

Want to read more about the history of Modufolin® and folates? Read more