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, 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 studies 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 members of the Board and Management.
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.
- Patient recruitment in the Pivotal phase 2-Study HORIZON completed
- New Interim Data in RRMM Patients with Extramedullary Disease from the Pivotal phase 2 Horizon-study presented at International Myeloma Workshop
- Oncopeptides completed a directed share issue of approximately SEK 727 million (USD 78 M)
- Oncopeptides decided to Apply for Accelerated Approval in the US
- Additional patent protection was granted for melflufen in the US until 2033
- Oncopeptides presented updated data from the cinical studies O-12-M1, HORIZON and ANCHOR at multiple conferences including ASCO, EHA, SOHO
- Oncopeptides completed a directed share issue of approximately SEK 546 million (USD 62 M)
- Oncopeptides held a Capital Markets Day in New York
- Oncopeptides presents first interim data from the ongoing phase 2 combination study ANCHOR and updated Interim data from the ongoing HORIZON study at the American Society of Hematology Meeting
- First patient included in the phase II-study BRIDGE in RRMM patients with renal impairment
- Oncopeptides presented updated interim data from the ongoing HORIZON phase 2 Study with melflufen at the 23rd Congress of The European Hematology Association (EHA)
- The phase 1/2 combination Study ANCHOR with melflufen started
- Oncopeptides performed a directed share issue of SEK 314 million
- Additional patent protection for melflufen was granted in Japan until October 2033
- Oncopeptides presented survival data from the phase 2 Study, O-12-M1 of melflufen. Interim data from the ongoing phase 2-study HORIZON was also presented at the 59th Annual Meeting of ASH
- The phase 3 Clinical study OCEAN with melflufen in RRMM patients started
- Additional patent protection for melflufen was granted in Europe until 2032
- Oncopeptides AB was listed on the Nasdaq Stockholm Stock Exchange
- The phase 2 Clinical study, HORIZON, in patients with Relapsed and Refractory Multiple Myeloma (RRMM) in late stage started
- Approval of phase 3 protocol with MHRA and the FDA through Special Protocol Assessment
- Scientific Advice meetings held with European authorities and the FDA regarding phase 3 design
- End of phase 2 meeting held successfully with the FDA based on late-stage multiple myeloma patients clinical data
- Phase 2 part of the phase 1/2 study presented at the European Hematology Association
- Melflufen received Orphan Drug Designation in the EU and US
- Phase 1 part of the phase 1/2 study in late-stage multiple myeloma patients presented at the American Society of Hematology annual meeting
- Phase 1/2 study initiated in late-stage multiple myeloma patients together with Harvard Medical School / DFCI as lead hospital
- HealthCap and Industrifonden, together with participation by the Chairman of the Board and the CEO, provided financing for the clinical phase 1/2 programme in late-stage multiple myeloma patients
- Industrifonden acquired Karolinska Development’s stake in the Company
- HealthCap became a shareholder
- Research collaboration with Harvard Medical School – Dana-Farber Cancer Institute (“DFCI”)
- New melflufen freeze-dried pharmaceutical formulation developed and patented
- Development of pharmaceutical formulation as melflufen has shown instability in its original liquid format
- Phase 1 study in solid tumours conducted with Akademiska sjukhuset in Uppsala, Sweden, as lead hospital
- Pre-clinical development stage, funded by Industrifonden and Karolinska Development AB
- Melflufen was patented
- Oncopeptides AB was founded to further develop drug candidates, including the future melflufen