More than 20 years of passionate drug development

Oncopeptides AB (publ) was formed in year 2000 by some of Sweden’s leading cancer researchers and cancer research institutions. More than 20 years later the company is dedicated to providing patient access to its innovative alkylating drug.

2000 Oncopeptides is formed

  • Oncopeptides AB is founded to further develop drugs candidates, including melflufen
  • Melflufen becomes patent protected

2003–2009 Research & development phase

  • Preclinical development phase, financed by Industrifonden and Karolinska Development AB

2009–2011 First clinical studies and research collaboration in the US

  • Phase 1 study in solid tumors conducted at Uppsala University Hospital, Sweden
  • Research collaboration established with Harvard Medical School – Dana-Farber Cancer Institute
  • New freeze-dried drug formulation of melflufen is developed and patented

2012–2013 Important investments in the future

  • Phase 1/2 study initiated in multiple myeloma patients, the study was led by Harvard Medical School – Dana-Farber Cancer Institute
  • HealthCap and Industrifonden, together with a number of key individuals in the company, provide funding for the Phase 1/2 clinical program in late-stage multiple myeloma patients
  • Industrifonden acquires Karolinska Development’s shares in Oncopeptides
  • HealthCap becomes a shareholder

2014–2015 Orphan Drug Designation and promising phase 1 data

  • Melflufen is granted Orphan Drug Designation in the EU and US
  • The phase 1 part of the phase 1/2 study in patients with late-stage multiple myeloma is presented at the American Society of Hematology’s annual meeting

2016 Expanded dialog with regulatory authorities

  • Scientific meetings with European authorities and FDA regarding the design of a phase 3 study
  • Meeting with the FDA regarding the completed phase 2 study in late-stage multiple myeloma patients
  • The phase 2 of the phase 1/2 study presented to the European Hematology Association

2017 Oncopeptides becomes a public company

  • The phase 2 study HORIZON is initiated
  • Overall survival data from the phase 2 study and interim data from the ongoing phase 2 HORIZON study are presented at the American Society of Hematology, ASH
  • The phase 3 OCEAN study with melflufen in patients with relapsed refractory multiple myeloma is initiated
  • Melflufen is granted additional patent protection in Europe until 2032
  • Oncopeptides is listed on Nasdaq Stockholm

2018 Organization expands and raises ambitions

  • Phase 1/2 combination study ANCHOR with melflufen is initiated
  • First interim data from the ongoing Phase 2 combination study ANCHOR and updated interim data from HORIZON presented at the American Society of Hematology, ASH
  • First patient enrolled in the phase 2 BRIDGE study in patients with relapsed refractory multiple myeloma with renal impairment
  • Updated interim data from the ongoing phase 2 HORIZON study with melflufen is presented at the European Hematology Meeting, EHA

2019 US application and additional research data

  • New interim data from the Phase 2 HORIZON study presented at the International Myeloma Workshop
  • Decision to apply for conditional approval in the US is made
  • Updated data from the clinical studies O-12-M1, HORIZON and ANCHOR are presented at several congresses, including ASCO, EHA and SOHO

2020 A commercial stage biotech company

  • The organization is strengthened to prepare for the commercial launch of melflufen in the US
  • An application for conditional approval of melflufen in combination with dexamethasone for the treatment of multiple myeloma is submitted to the FDA
  • Oncopeptides develops into a fully integrated global biotech company
  • The FDA approves the application to start clinical studies in the US for OPD5, the second drug candidate based on the proprietary PDC platform
  • Enrollment to the phase 3 OCEAN study is completed. The first results are expected in the first half of 2021
  • First patient enrolled in phase 1/2 study with AL amyloidosis, the first study to investigate the effect of melflufen outside of multiple myeloma
  • A lab in Solna for pre-clinical drug development is established
  • Final data from the pivotal phase 2 study HORIZON is presented at the virtual European Hematology Congress, EHA

2021 Science shows the way

  • On February 26, the FDA grants conditional approval to Pepaxto plus dexamethasone for the treatment of adult patients with relapsed, refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is resistant to at least one proteasome inhibitor, one immunomodulatory drug and one monoclonal antibody drug targeting CD38
  • A European business unit is formed to prepare the commercialization of melflufen in the EU. In addition, a so-called Early Access program was initiated to provide early access to melflufen for patients with no or few treatment options
  • Oncopeptides submits an application to the European Medicines Agency (EMA) for conditional approval of melflufen plus dexamethasone in the EU based on the phase 2 HORIZON study
  • Results from the phase 3 OCEAN study are published. Melflufen met the primary endpoint of progression-free survival (PFS) in a direct comparison with pomalidomide. However, the overall survival in the so-called Intention to Treat population, showed a hazard ratio of 1.10 in favor of pomalidomide
  • Based on unsatisfactory survival data, the FDA requests that enrollment of new patients in all clinical trials be stopped. The FDA also issues a safety alert for Pepaxto and calls for an expert public advisory committee (ODAC) meeting to discuss the future of Pepaxto
  • On October 22, Oncopeptides decides to withdraw Pepaxto from the US market and return to being a Sweden-based research and development company, focused on further developing the proprietary PDC platform
  • The application process to the European Medicines Agency, EMA, for a potential market authorization continues

2022 A transformative year

  • Phase 3 study OCEAN is published in The Lancet Haematology
  • Oncopeptides rescinds the voluntary withdrawal of Pepaxto in the US, based on additional analyses of survival data from OCEAN and other relevant studies
  • The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommends a full approval of Pepaxti in combination with dexamethasone in Europe for the treatment of triple-class refractory multiple myeloma
  • The European Commission grants marketing authorization for Pepaxti in combination with dexamethasone in the EU, as well as in the EEA countries Iceland, Lichtenstein and Norway
  • Commercialization in Europe begins, with Germany as the first market
  • The clinical benefit of melflufen is further confirmed in the phase 3 LIGHTHOUSE study
  • Pepaxti receives market authorization from the MHRA in the UK
  • The company enters into a renewed loan agreement of up to EUR 30 million with the European Investment Bank
  • At the end of the year, the FDA requests the withdrawal of the marketing authorization for Pepaxto in the US

2023 Commercialization in Europe

  • German sales initiated while a full marketing team is built and fully recruited by the end of the year
  • First sales of Pepaxti in Greece
  • In July, the FDA reiterates its request that Oncopeptides withdraw Pepaxto in the US, a decision that the company chooses to appeal. A decision is expected in the second half of 2023
  • Sofia Heigis, former CCO, becomes CEO of the company in August, and Henrik Bergentoft takes over as CFO towards the end of the year
  • Oncopeptides publishes two articles with results from the ANCHOR and LIGHTHOUSE studies in Haematologica
  • Successful price negotiations between Oncopeptides and German payment authorities lead to a German price for Pepaxti of €7,058
  • The medicines agency EMA recommends that Pepaxti be approved for use in earlier lines of therapy, which would increase its potential use but at a lower price, later prompting the company to withdraw its application
  • Article with exploratory alkylator-refractory subgroup analysis from Oncopeptides OCEAN study observing longer PFS and OS in melflufen compared to pomalidomide is published in the European Journal of Hematology
  • Oncopeptides are selected to present additional data from the OCEAN study at the American Society of Hematology congress