Isofol’s partner Solasia intends to increase investments in upcoming trials with arfolitixorin

The information in the press release is intended for investors.

In conjunction with a current visit to Tokyo, Japan, by Isofol’s Chairman Jan-Eric Österlund, CEO Petter Segelman Lindqvist and CMO Dr. Roger Tell, Isofol is able to reconfirm the details of Solasia’s recently updated development plans for Isofol’s drug candidate arfolitixorin and give it its full endorsement. Solasia has announced an increased commitment to developing arfolitixorin and will sponsor upcoming Japanese phase II and III trials, while Isofol will support the program and ensure alignment with the clinical development in other geographical regions.

To secure funding for the clinical program in Japan, Solasia has launched a new warrant program corresponding to approximately 140 MSEK (JPY ~2.1 bn) that will exclusively fund the trials as well as regulatory submissions. According to Solasia, the phase II trial is planned for 2025 and 2026, followed by phase III and regulatory submission between 2027 and 2029.

During the visit in Tokyo, Isofol have also had the opportunity to visit two prominent hospitals and affiliated medical experts: Professor Dr. Yu Sunakawa at the department of Clinical Oncology at the St Marianna University School of Medicine in Kawasaki, who is supporting Isofol with its current phase Ib/II trial; as well as with Isofol’s advisory board member Dr. Takayuki Yoshino, MD, Ph.D., at the Department of Gastrointestinal Oncology, National Cancer Center Hospital East in Chiba. Dr. Yoshino is also the Chairman of the Japan Society of Clinical Oncology.

Isofol and Solasia also participated in joint meetings with the clinical research organization selected for the Japanese trial program, to plan for the upcoming trials and consultations with the Japanese pharmaceutical regulatory authority, PMDA.

“We are very pleased with the trust and confidence Solasia places in arfolitixorin. The new, significant investment in our drug candidate is a strong testament to their engagement. We share the same aim of improving the outcomes for chemotherapy-treated patients facing difficult forms of cancer, and as Solasia is now announcing its plans for a complete Japanese development program, we are moving closer to realizing this vision. We are also energized by the discussions with Prof. Sunakawa and Dr. Yoshino and their involvement in Isofol’s clinical development,” says Petter Segelman Lindqvist, CEO of Isofol.

For more information, please contact
Isofol Medical AB (publ)
Petter Segelman Lindqvist, Chief Executive Officer 
E-mail: petter.s.lindqvist@isofolmedical.com
Phone: +46 (0) 739 60 12 56

The information was submitted for publication, through the agency of the contact person set out above, at 08:00 CEST, on April 3, 2025.

About Isofol Medical AB (publ)
Isofol Medical AB (publ) is a research-based biotechnology company working to improve the prognosis for patients with severe forms of cancer. The company's drug candidate arfolitixorin aims to increase the effect of first-line standard treatment for several forms of solid tumors and is currently being studied in colorectal cancer, the world's third most common cancer, where the medical need for better treatments is urgent. A phase Ib/II study is now being conducted with a new dosing regimen that is expected to optimize the effect of the drug candidate. Isofol Medical AB (publ) is traded on Nasdaq Stockholm.
www.isofolmedical.com

About the collaboration with Solasia Pharma K.K.
Isofol Medical AB (publ) has licensed out the development and commercialization rights for arfolitixorin in Japan to Solasia Pharma K.K, a company working to bring innovative medicines to Japan and other Asian countries. Under the terms of the agreement, Isofol will receive tiered double-digit royalties on net sales made by Solasia in Japan as well as upfront, development, regulatory and sales-based milestone payments.
http://www.solasia.co.jp/en/