Isofol Medical AB (publ)

Isofol initiates last dose cohort in ongoing phase Ib study with arfolitixorin

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Positiv

Sammanfattning

Isofol Medical AB har initierat den sista doskohorten i sin fas Ib/II-studie med arfolitixorin. Detta följer godkännande från säkerhetskommittén efter positiva resultat från tre tidigare dosnivåer. Fas II-delen av studien planeras att inledas under andra halvåret 2026.

Analys

Bolaget fortskrider enligt plan i sin kliniska studie med arfolitixorin. Initieringen av den sista doskohorten i fas Ib är en viktig milstolpe som möjliggör övergången till fas II. De hittillsvarande resultaten visar en gynnsam säkerhetsprofil utan dosbegränsande toxicitet, vilket stärker förtroendet för den valda doseringsregimen. Detta steg närmar bolaget mot potentiell kommersialisering av en ny cancerbehandling.

Insikter

  • • Initieringen av den sista doskohorten är en viktig milstolpe som för bolaget närmare fas II.
  • • Den positiva säkerhetsprofilen utan dosbegränsande toxicitet stärker förtroendet för läkemedelskandidaten.
  • • Arfolitixorin adresserar ett betydande medicinskt behov inom kolorektalcancer.

GOTHENBURG, Sweden, July 8, 2026 - Isofol Medical AB (publ), (Nasdaq Stockholm: ISOFOL), announces today that the company has completed the third dose level in the dose-escalation part of the phase Ib/II study with arfolitixorin. Following approval from the safety review committee, the next dose level – also the final one in the dose-escalation – has now been initiated.

GOTHENBURG, Sweden, July 8, 2026 - Isofol Medical AB (publ), (Nasdaq Stockholm: ISOFOL), announces today that the company has completed the third dose level in the dose-escalation part of the phase Ib/II study with arfolitixorin. Following approval from the safety review committee, the next dose level – also the final one in the dose-escalation – has now been initiated.

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, initially conducted at the German hospital Charité – Universitätsmedizin Berlin. The drug candidate has the potential to fill a known treatment gap in cancer care.

The study is conducted in two parts, with the first part, phase Ib, evaluating increasing doses of the drug substance in patients with metastatic colorectal cancer. The third dose level, at 300 mg/m², was recently completed and successfully evaluated without dose-limiting toxicities. Based on recommendations from the study’s safety review committee, Isofol has decided that the newly initiated dose level, evaluating 500 mg/m², will be the final one in the dose-escalation phase. This decision is based on the favorable results generated in the three previous dose cohorts. Isofol continues to plan for the initiation of the phase II part of the arfolitixorin study in the second half of 2026.

“The fact that we can now initiate the final dose cohort and thereby move closer to the Phase II part of the study is an important milestone in the development of arfolitixorin. The results from the three dose levels completed so far in patients with metastatic colorectal cancer continue to support the dosing regimen underlying the study, and the safety profile has consistently been favorable,” says Petter Segelman Lindqvist, CEO of Isofol.

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 contactIsofol Medical AB (publ)Petter Segelman Lindqvist, Chief Executive Officer E-mail: petter.s.lindqvist@isofolmedical.comPhone: +46 (0) 739 60 12 56

The information was submitted for publication, through the agency of the contact person set out above, at 11:30 CEST on July 8, 2026.

About IsofolIsofol Medical AB (publ) is a clinical stage biotechnology company focused on improving outcomes for patients with severe forms of cancer. The Company’s drug candidate arfolitixorin, a next generation folate treatment, is designed to enhance the efficacy of established standard treatments for several types of solid tumors. Arfolitixorin is currently being evaluated in phase Ib/II in colorectal cancer, the world’s third most common cancer, where there is a significant unmet medical need. Isofol is listed on Nasdaq Stockholm.www.isofolmedical.com

Attachments20260708_Isofol_PM_Phase Ib Dose cohort III

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