Press release

Oncopeptides launches new real-world evidence study of Pepaxti in Spain, first patient enrolled

May 20, 2025

Stockholm, May 20, 2025 – Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on difficult-to-treat cancers, today announces that the first patient has been enrolled in its new real-world evidence study, evaluating the use of Pepaxti in routine clinical settings across Spain.

The non-interventional study OP-115, named LAGOON, will include approximately 50 adult patients at approximately 20 participating sites. Its objective is to collect real-world clinical data on the effectiveness and safety of Pepaxti in patients with relapsed, refractory multiple myeloma (RRMM), reflecting the approved indication. This marks the first study of its kind for Pepaxti in Spain and is expected to generate important insights to support clinical decision-making and future market development.

“Beginning the LAGOON study with our first enrolled patient, from Hospital Universitario de Cabueñes in Asturias, is an important milestone in understanding how Pepaxti performs in real-world conditions,” says Enrique Ocio, Head of the Hematology Department at Marqués de Valdecilla University Hospital in Santander and principal investigator of the study. “We’re proud to contribute to the advancement of care for patients with RRMM through this collaboration with Oncopeptides.”

“This is a crucial step in building the real-world evidence base for Pepaxti,” says Sofia Heigis, CEO of Oncopeptides. “Spain represents an important market for Oncopeptides, and we are excited to work alongside clinicians to broaden our understanding of how Pepaxti benefits patients outside of the clinical trial setting.”

The results of the LAGOON study will support Oncopeptides’ efforts to provide relevant real-world data to healthcare providers, payers, and regulators across Europe.

In July 2024, Oncopeptides communicated the first patient in a similar real-world study in Germany, named HARBOUR.

For more information, please visit www.oncopeptides.com, where a Q&A for investors will also be published.