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

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