STOCKHOLM - March 16, 2026 - Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company specializing in difficult-to-treat cancers, today announces the initiation of the MARINA study in close collaboration with iOMEDICO. This investigator-initiated, prospective, non-interventional study (NIS) is designed to evaluate the real-world effectiveness, safety, and treatment patterns of Pepaxti (melflufen) in combination with dexamethasone for patients with relapsed, refractory multiple myeloma (RRMM).
The study focuses on adult patients in Germany who have received at least three prior lines of therapy. By observing 50 patients across approximately 25 sites, MARINA aims to bridge the gap between controlled clinical trials and routine clinical practice.
"The MARINA study represents a sophisticated approach to capturing the nuances of modern myeloma management," says Dr. Patrick Marschner, Scientific Leader at iOMEDICO. "By evaluating parameters such as the Disease Control Rate and the drug's utility as a bridging therapy to novel immunotherapies, we are providing German hematologists with the high-quality evidence they need to optimize patient care in late-line settings".
The study is conducted as an investigator-initiated study with iOMEDICO serving as the sponsor and coordinator, with financial support provided by Oncopeptides.
"While pivotal trials like OCEAN and HORIZON provided the regulatory foundation for Pepaxti, the 'real world' is often more complex than a controlled clinical environment," says Sofia Heigis, CEO of Oncopeptides. "MARINA will provide essential data on how Pepaxti performs in diverse patient populations-including older patients and those with significant comorbidities - informing prescribers how Pepaxti can make a difference for patients in a real world setting."
Key Objectives of the MARINA Study
The study utilizes the innovative SYNERGY operational platform, which allows for agile center activation once an eligible patient is identified. Key areas of evaluation include:
- Primary Effectiveness: Assessing the Disease Control Rate (DCR), a metric of high value for patients in late-stage disease.
- Safety & Tolerability: Continuous monitoring of (serious) adverse events and adverse drug reactions in a routine setting.
- Bridging Therapy Utility: Investigating how physicians use Pepaxti as a bridging therapy prior to other immunotherapies, such as CAR-T cells or bispecific antibodies.
- Quality of Life (QoL): Evaluating patient-reported outcomes to understand the global health status of patients during treatment.
The MARINA study is scheduled to begin enrolment with the first patient in during the second quarter of 2026.
For more information, including a Q&A for investors, please visit www.oncopeptides.com.
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.
