Oncopeptides secures fast-track designation for Window-of-Opportunity study
Oncopeptides has achieved key regulatory agreement with both the Swedish and Norwegian Medical Products Agencies regarding the design of its planned “Window-of-Opportunity” study evaluating a Peptide Drug Conjugate (PDC) in glioblastoma.
The study will be conducted in Norway, where DMP has granted fast-track designation.
This WoO study represents the first clinical evaluation of a PDC in glioblastoma, marking a significant and strategic milestone for Oncopeptides as the company expands the application of its PDC platform beyond multiple myeloma, it states.
The study will utilize Oncopeptides’ already approved drug in approximately 10 patients with glioblastoma, to provide rapid human proof-of-concept for brain penetration. This efficient study design aims to validate the mechanism in a cost-efficient manner before advancing a PDC into dose-finding and larger trials, for a global glioblastoma market estimated to be worth more than 8 billion USD in 2035 and with high unmet medical need.
“Reaching regulatory agreement with authorities in both Sweden and Norway is a significant milestone for Oncopeptides” says Sofia Heigis, CEO of Oncopeptides. “The planned Window of Opportunity study is the first time our PDC platform will be evaluated in glioblastoma, and it marks a significant step in expanding the potential of our technology beyond multiple myeloma. The constructive dialogue with MPA and DMP, together with the fast‑track designation granted in Norway, reinforces our confidence in the scientific rationale and clinical relevance of this program. We believe this study will generate important insights and further support our ambition to bring innovative, targeted therapies to patients with high unmet medical need.”
Published: March 9, 2026
