Oncopeptides’ drug Pepaxti included in European Guidelines for the treatment of multiple myeloma
Idag, 08:20
Stockholm, July 8, 2025 – Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on difficult-to-treat cancers, today announces that its drug Pepaxti has been included in new clinical practice guidelines from EHA-EMN* for patients with relapsed, refractory multiple myeloma. This marks an important recognition by leading experts of the drug’s clinical value and ability to meet an unmet medical need in the treatment of this serious blood cancer.
The guidelines are based on a thorough evaluation of clinical evidence by leading experts and aim to support doctors in selecting appropriate therapies for their patients. For patients who have received multiple prior lines of therapy and are triple-class refractory/exposed (TCR/TCE) – meaning their disease no longer responds to three major classes of myeloma drugs – Pepaxti is recommended based on Level 1 evidence, the strongest possible, and has a Grade B recommendation.
“The fact that Pepaxti has received a recommendation by this expert group once again confirms the drugs’ value in later lines of treatment and will support awareness of Pepaxti as a treatment option,” says Sofia Heigis, CEO at Oncopeptides. “We are happy to see Pepaxti having the highest combination of recommendation and clinical evidence of all non-CAR T therapies, supporting the use of Pepaxti as the first choice in subsequent treatment of multiple myeloma.”
Furthermore, Pepaxti has also been listed as a treatment option for patients with even more advanced disease, TCR/TCE patients relapsing after immunotherapy with either CAR-T cells or ADC and whose disease no longer responds to four drug classes.
“It is encouraging that Pepaxti is included as an option for even the most treatment-resistant patient population,” says Stefan Norin, Chief Medical Officer at Oncopeptides. “This reflects growing trust in the drug’s clinical performance in the pivotal studies and real-world settings.”
For Oncopeptides, this recognition is an important step toward broader use of Pepaxti in Europe and a strong signal of its potential to help patients with few remaining treatment options.
For more information, please visit Oncopeptides’ website, www.oncopeptides.com, where a Q&A for investors will be published.
* EHA-EMN refers to the collaboration between the European Hematology Association (EHA) and the European Myeloma Network (EMN). These organizations work together to advance research, clinical practice, and education in the field of hematology, with a particular focus on multiple myeloma.
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.
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Oncopeptides’ drug Pepaxti included in European Guidelines for the treatment of multiple myeloma
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Oncopeptides’ drug Pepaxti included in European Guidelines for the treatment of multiple myeloma
Idag, 08:20
Stockholm, July 8, 2025 – Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on difficult-to-treat cancers, today announces that its drug Pepaxti has been included in new clinical practice guidelines from EHA-EMN* for patients with relapsed, refractory multiple myeloma. This marks an important recognition by leading experts of the drug’s clinical value and ability to meet an unmet medical need in the treatment of this serious blood cancer.
The guidelines are based on a thorough evaluation of clinical evidence by leading experts and aim to support doctors in selecting appropriate therapies for their patients. For patients who have received multiple prior lines of therapy and are triple-class refractory/exposed (TCR/TCE) – meaning their disease no longer responds to three major classes of myeloma drugs – Pepaxti is recommended based on Level 1 evidence, the strongest possible, and has a Grade B recommendation.
“The fact that Pepaxti has received a recommendation by this expert group once again confirms the drugs’ value in later lines of treatment and will support awareness of Pepaxti as a treatment option,” says Sofia Heigis, CEO at Oncopeptides. “We are happy to see Pepaxti having the highest combination of recommendation and clinical evidence of all non-CAR T therapies, supporting the use of Pepaxti as the first choice in subsequent treatment of multiple myeloma.”
Furthermore, Pepaxti has also been listed as a treatment option for patients with even more advanced disease, TCR/TCE patients relapsing after immunotherapy with either CAR-T cells or ADC and whose disease no longer responds to four drug classes.
“It is encouraging that Pepaxti is included as an option for even the most treatment-resistant patient population,” says Stefan Norin, Chief Medical Officer at Oncopeptides. “This reflects growing trust in the drug’s clinical performance in the pivotal studies and real-world settings.”
For Oncopeptides, this recognition is an important step toward broader use of Pepaxti in Europe and a strong signal of its potential to help patients with few remaining treatment options.
For more information, please visit Oncopeptides’ website, www.oncopeptides.com, where a Q&A for investors will be published.
* EHA-EMN refers to the collaboration between the European Hematology Association (EHA) and the European Myeloma Network (EMN). These organizations work together to advance research, clinical practice, and education in the field of hematology, with a particular focus on multiple myeloma.
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.
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Oncopeptides’ drug Pepaxti included in European Guidelines for the treatment of multiple myeloma
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