Oncopeptides AB was formed in 2000 to develop anti-cancer drugs based on research by some of Sweden’s leading cancer researchers and cancer research institutions.
The focus of Oncopeptides’ current development, melflufen (Ygalo®), is a result of work originally undertaken by Dr Joachim Gullbo at Uppsala University, Sweden, and in particular his development of a molecule that was first known as ‘J1’ and later as melflufen.
Backed initially by funding from one of Sweden’s leading venture capital firms, Industrifonden, and the development arm of the Karolinska Institutet, Oncopeptides embarked on the pre-clinical development stages.
Following an early study into the effectiveness of ‘J1’ in solid tumours, further work resulted in the molecule that is now melflufen. During this period, Oncopeptides also established a research collaboration with the Harvard Medical School – Dana Farber Cancer Institute in the USA.
Oncopeptides was then able to embark on the Phase 1 and Phase 2 clinical trials of melflufen in late-stage multiple myeloma patients. These studies were financed by Healthcap, a life sciences venture capital fund, and Industrifonden together with participation by the Chairman of the Board and the CEO.
In 2015 following the completion of Phase 1 of the Phase 1/2 study, melflufen was granted Orphan Drug Designation by both the US and EU regulatory authorities, the benefits of which include extended exclusive marketing rights.
There was an intensification of Oncopeptides clinical research and regulatory engagement in 2016. The Phase 2 element of the Phase 1/2 study was presented to the European Hematology Association and several productive meetings were held with the US Food and Drug Administration (FDA) and European authorities.
In the course of 2016, the detailed design of the melflufen Phase 3 study was approved through the US FDA’s Special Protocol Assessment process, which if the study achieves its statistical targets, will lead to marketing approval.
- Oncopeptides AB was founded to further develop drug candidates, including the future melflufen
- Melflufen was patented
- Pre-clinical development stage, funded by Industrifonden and Karolinska Development AB
- Phase 1 study in solid tumours conducted with Akademiska sjukhuset in Uppsala, Sweden, as lead hospital
- Development of pharmaceutical formulation as melflufen has shown instability in its original liquid format
- New melflufen freeze-dried pharmaceutical formulation developed and patented
- Research collaboration with Harvard Medical School – Dana-Farber Cancer Institute (“DFCI”)
- HealthCap became a shareholder
- Industrifonden acquired Karolinska Development’s stake in the Company
- HealthCap and Industrifonden, together with participation by the Chairman of the Board and the CEO, provided financing for the clinical Phase1/2 programme in late-stage multiple myeloma patients
- Phase 1/2 study initiated in late-stage multiple myeloma patients together with Harvard Medical School / DFCI as lead hospital
- Phase 1 part of the Phase 1/2 study in late-stage multiple myeloma patients presented at the American Society of Hematology annual meeting
- Melflufen received Orphan Drug Designation in the EU and US
- Phase 2 part of the Phase 1/2 study presented at the European Hematology Association
- End of Phase 2 meeting held successfully with the FDA based on late-stage multiple myeloma patients clinical data
- Scientific Advice meetings held with European authorities and the FDA regarding Phase 3 design
- Approval of Phase 3 protocol with MHRA and the FDA through Special Protocol Assessment