Collaborators

Solasia Pharma K.K.

Isofol has established a regional license agreement for Japan, the world’s second largest pharmaceutical market, with Solasia Pharma K.K. The agreement has a total value of 100 million dollars, consisting of initial payments and future milestone payments linked to clinical development, regulatory processes and sales. Additionally, Isofol is entitled to an incremental double-digit royalty based on the future net sales. This agreement provides insight into the potential value that licensing in other regions of the world, or alternatively a divestment of the project, could generate.
In March 2024, Solasia announced their continued strong commitment to the development of arfolitixorin, and in August, the company confirmed their readiness to finance potentially upcoming studies in Japan. Solasia contributes with their expertise on an ongoing basis and participates in shaping the details of the clinical development program. By the end of 2024, Solasia announced their intention to expand the Phase II portion of the upcoming study to include Japanese patients in 2026. This inclusion significantly increases the study size and enhances diversity in the patient population, creating a solid foundation for subsequent regulatory processes in both Japan and other geographic markets.

Endo Inc. och Paladin Pharma Inc.

Additionally, Isofol has a license agreement with Paladin Pharma Inc. covering commercialization in the Canadian market, which will also generate royalty income from future sales. As the clinical development program advances, discussions will be initiated with additional potential partners for other regions of the world, regarding both further clinical development and commercialization.

Merck – experts in the processing of substance

Isofol maintains a strategic research and development partnership with Merck Life Science KGaA, Germany, and its Swiss subsidiary Merck & Cie. This partnership, formalized through a global licensing agreement, offers numerous synergies. Isofol contributes with specialized knowledge in the development and application of arfolitixorin for cancer treatments, while Merck & Cie provides expertise in synthesizing of a stable API (active pharmaceutical ingredient) of [6R]-MTHF as well as formulating a stable and sustainable drug.

Charité-Universitätsmedizin Berlin

Isofol has established a collaboration with Charité-Universitätsmedizin Berlin, Germany, and its Department of Hematology, Oncology and Cancer Immunology (CCM) headed by Professor Sebastian Stintzing, MD. The collaboration focuses on the further development of the drug candidate arfolitixorin for colorectal cancer and other solid tumors. Under this agreement, Isofol and Charité – Universitätsmedizin Berlin will jointly conduct the Phase Ib/II clinical study. Professor Stintzing serves as the coordinating investigator of the study.

Link Medical – CRO

A Clinical Research Organization (CRO) is a company that assists with the practical implementation of clinical studies, something that is entirely necessary for a company of Isofol’s size. A CRO may, for example, provide statistical calculations and analyses, have databases for study data, work with preclinical studies, mark and distribute drugs for studies and assist companies when resources and geographic distance make it difficult to work directly with hospitals. Link Medical is Isofol’s primary CRO that manages the clinical study on behalf of and in collaboration with Isofol.

Recipharm – commercial manufacturer

Recipharm in Wasserburg, Germany has been a partner for the manufacturing of Isofol’s product, arfolitixorin, since 2015. A large-scale production process is in place and Isofol has a close dialogue with Recipharm to secure manufacturing and deliveries in connection with the clinical studies.

Other partnerships

In addition to the above mentioned partners, Isofol maintains close collaborations with advisors and experts in regulatory affairs, statistical planning and analysis, intellectual property and patents, legal matters, and other fields.