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First patient enters Oncopeptides study aiming to gain real-world insights from Pepaxti in Germany

Stockholm, July 22, 2024 – Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on difficult-to-treat cancers, today announces entry of the first patient in a new study evaluating the real-world effectiveness and safety of Pepaxti in German patients. The study, which will include 100 patients across around 50 sites in Germany, aims at gathering evidence on Pepaxti’s effectiveness and safety in a real-world clinical practice and is the first Pepaxti study engaging treating physicians at multiple German sites.

The study, named HARBOUR, will assess real-life clinical outcomes of Pepaxti treatment of patients suffering from refractory, relapsed multiple myeloma (RRMM) in a patient population that mirrors the indication of Pepaxti. The study marks another step forward in Oncopeptides’ ongoing efforts to strengthen the medical understanding of Pepaxti and will support the evidence base for the Pepaxti indicated population. 

"Initiating the HARBOUR study with the enrollment of the first patient is a pivotal step forward to address the unmet needs of RRMM patients," says Dr. med. Johannes Waldschmidt, the Scientific Leader of the study from Universitätsklinikum Würzburg, Germany. "This partnership with Oncopeptides offers an opportunity for the German medical community to contribute to significant advancements in myeloma treatment and patient care."

"Our aim is to understand the performance of Pepaxti in the real world. It is important evidence to generate, not only for the German market but for the full European commercialization," says Sofia Heigis, CEO of Oncopeptides. "We are happy to for the first time initiate a study across Germany and also the very first study that is fully focused on our target population.”

For more information, please visit the German Clinical Trials Register or Oncopeptides’ web site where questions and answers for investors will also be published.

For more information, please contact:
David Augustsson, Director of IR and Communications, Oncopeptides AB (publ)
E-mail: david.augustsson@oncopeptides.com
Cell phone: +46 76 229 38 68

About Oncopeptides
Oncopeptides is a biotech company focusing on research, development and commercialization of targeted therapies for difficult-to-treat cancers. The company uses its proprietary Peptide Drug Candidate platform (PDC) to develop compounds that rapidly and selectively deliver cytotoxic agents into cancer cells. 

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.

Oncopeptides is developing several new compounds based on its proprietary technology platforms and is listed on Nasdaq Stockholm with the ticker ONCO. For more information see: www.oncopeptides.com

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First patient enters Oncopeptides study aiming to gain real-world insights from Pepaxti in Germany

Datum 2024-07-22, kl 08:30
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First patient enters Oncopeptides study aiming to gain real-world insights from Pepaxti in Germany
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