Oncopeptides AB |
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Concept Development |
Lead Discovery |
Lead Optimization |
Preclinical Development |
Phase I |
Phase II |
Phase III |
Launch |
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Project: Melflufen (J1) |
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The Challenge
In spite of the progress made in treating recurrent and often therapy resistant cancer with new targeted drugs, treatment of most types of cancers remains a challenge. In most cases, treatment is performed by combining standard chemotherapy regimens with newly developed targeted agents if available. In order to improve on these regimens there is a need for new chemotherapeutic agents and treatment combinations that are more efficacious, or more specific, than current drugs in this class.
Oncopeptides' Solution
Oncopeptides develops targeted prodrugs of chemotherapeutic agents already approved for cancer treatment. Designed to be activated by enzymes that are over-expressed in tumor cells, they provide for accumulation of anticancer drugs more selectively in cancer cells compared to normal cells. In addition to direct effects on tumor cells, the company's drug candidate, melflufen, has also shown a strong inhibitory effect on the growth of blood vessels.
Competitive Advantages
Melphalan flufenamide has a considerable better uptake into tumor cells compared to melphalan and following hydrolysis by an enzyme that is overexpressed in many malignant tumors, melphalan flufenamide has the advantage of preferentially trapping the cytotoxic agent, at high concentrations in the tumor tissue. As a pro- drug to melphalan, melphalan flufenamide is considerably more active than melphalan.
The Market
The market for basic chemotherapeutic drugs is significant, as both Treanda (bendamustine) and Abraxane (albumin-bound paclitaxel) have recently shown, with global sales figures of around USD 500m each in 20111. Oncopeptides is initially focusing on hematologic cancers, which also represent significant markets. The first indication the company is focusing on is multiple myeloma. This is a disease where there is a great medical need and represents a significant market. Two big-selling drugs for multiple myeloma are Velcade (bortezomib) and Revlimid (lenalidomid), which are expected to attain sales of 2.2 and USD 3.6bn respectively in 20121.
Status
- Several potential therapeutic areas have been identified in which tumors have shown a high sensitivity to melflufen
- Synergistic effects with specific chemotherapeutic drugs have been verified in preclinical in vitro and in vivo studies
- The Phase I/II study to establish dose and side-effects profile has been completed
- A clinical development plan has been prepared for the indication of multiple myeloma

Planned Milestones
- Further strengthen the preclinical program
- Start a proof-of-concept study in multiple myeloma
- Obtain orphan drug status for faster route to market
Patent Status
Patent protection covering the drug candidate has been granted in the USA, Europe and Canada and is pending in Japan. The drug formulations have also been protected through patent applications.
Commercialization
The owners of Oncopeptides intend to license the project or sell the company during or after the Phase II studies.
- Source: Datamonitor PharmaVitae Explorer, 2012
| Contact: Jakob Lindberg, CEO | +46 70 569 54 71 | jakob.lindberg@oncopeptides.se | www.oncopeptides.se |
