GOTHENBURG, Sweden, February 24, 2026 - Isofol Medical AB (publ) (Nasdaq Stockholm: ISOFOL) today provides an update on the company's ongoing phase Ib/II clinical study of arfolitixorin, which is initially conducted at Charité - Universitätsmedizin Berlin. All patients evaluated to date in the study have shown tumor shrinkage without dose-limiting side effects, and half of them have unexpectedly become candidates for tumor surgery during treatment.
The information in the press release is intended for investors.
Isofol is developing arfolitixorin - a proprietary clinical-stage drug candidate designed to enhance the efficacy of established cancer treatments. Based on extensive clinical research, arfolitixorin is now being tested in a phase Ib/II clinical study with an optimized dose regimen. The drug candidate has the potential to fill a known treatment gap in cancer care.
The study is carried out in two stages, where the first part, phase Ib, evaluates escalating doses of the drug substance in patients with RAS-mutated metastatic colorectal cancer, a difficult-to-treat population. The study is currently evaluating the third dose level, 300 mg/m2. The subsequent phase II part will be conducted in a broader patient population and will include a control arm. Furthemore, the study will be expanded beyond Charité to several other hospitals in order to enable swift patient enrollment.
Ahead of the upcoming subscription period for Isofol's TO1 warrant program in March, the company today provides an update on the status of the ongoing open-label clinical study:
- To date, no dose-limiting side effects have been observed in the treated patients.
- Preliminary results show that all patients included in the study to date have responded to treatment and exhibited tumor shrinkage, with total tumor burden reductions of up to approximately 50 percent.
- Half of the six patients evaluated to date have responded so well to the treatment that they were removed from the study for consideration of tumor surgery (removal of the tumors), which is unexpected in this patient population where surgery is not normally considered feasible.
"Today's update from the ongoing study of arfolitixorin is highly promising, not least because in this initial phase we are focusing on a difficult-to-treat patient group with RAS-mutated metastatic colorectal cancer. That all patients have responded to treatment, and that several of them have improved to such an extent that they have been able to undergo tumor surgery, is unexpectedly positive," says Prof. Dr. med. Sebastian Stintzing at Charité Universitätsmedizin and lead investigator in the study.
"I am very happy to release this update. It indicates is that the new, optimized dosing regimen so far is both safe and efficacious - which is very promising for the continued development and as we proceed towards the next phase in the trial," says Isofol's CEO Petter Segelman Lindqvist.
Further results from the ongoing study will be presented at upcoming medical congresses during the year.
Colorectal cancer is the third most common form of cancer globally, and the second most common cause of cancer-related death, according to the World Health Organization (WHO). The need for new treatments in the field is, therefore, high.
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
This information is information that Isofol Medical AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 09:32 CET on February 24, 2026.
About Isofol
Isofol Medical AB (publ) works to improve the quality of life and 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 truly urgent. A phase Ib/II study is now being conducted with a new dosage regimen that are expected to optimize the effect of the drug candidate. Isofol Medical AB (publ) is traded on Nasdaq Stockholm.
www.isofolmedical.com
