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.
For more information, please contact:
David Augustsson, Director of IR and Communications, Oncopeptides AB (publ)
E-mail: ir@oncopeptides.com
Cell phone: +46 76 229 38 68
About Oncopeptides
Oncopeptides is a Swedish biotech company focusing on research, development and commercialization of targeted therapies for difficult-to-treat cancers.
The company uses its proprietary Peptide Drug Conjugate platform (PDC) to develop compounds that rapidly and selectively deliver cytotoxic agents into cancer cells. Its flagship drug is currently being commercialized in Europe with partnership agreements for South Korea, the Middle East and Africa and elsewhere.
Oncopeptides is also developing several new compounds based on its two proprietary technology platforms PDC and SPiKE.
The company was founded in 2000, has about 80 employees with operations in Sweden, Germany, Austria, Spain and Italy. Oncopeptides is listed on Nasdaq Stockholm with the ticker ONCO.
For more information see: www.oncopeptides.com
About Pepaxti
Pepaxti® (melphalan flufenamide, also called melflufen) has been granted Marketing Authorization, in the European Union, the EEA-countries Iceland, Lichtenstein and Norway, as well as in the UK. Pepaxti is indicated in combination with dexamethasone for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. For patients with a prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation.
