Partnerships

Isofol has established a comprehensive network with expertise in fields such as oncological research, clinical studies, manufacturing, patent issues, and commercialization. Together, these partnerships create favorable conditions for advancing the development of arfolitixorin.

Isofol is led by individuals with extensive experience in pharmaceutical and business development. The company operates in a cost-effective manner, utilizing a well-established network of leading experts in the field who are engaged on a consultancy basis. This approach provides Isofol access to essential expertise in areas including research, production (CMC), quality assurance (QA), patent matters, clinical drug development and business development. With support from highly competent, quality-focused, and flexible partners, active knowledge exchange in external networks, and collaborations with academic institutions, the work to improve current cancer treatments continues.

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 provides expertise in synthesizing of a stable API (active pharmaceutical ingredient) of [6R]-MTHF as well as formulating a stable and sustainable drug. The companies engage in ongoing collaboration regarding, for example, intellectual property and patents as well as further product development.

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 and will expand the phase II part 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.

Knight Therapeutics Inc.

Isofol has a license agreement with Knight Therapeutics Inc. (formerly 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.

Charité – Universitätsmedizin Berlin

Isofol has established a research 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 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

Clinical Research Organization; a company specialized in the practical conduct of clinical studies. 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.