The clinical drug candidate EndoTAG®-1 is a novel composition of the established cytostatic drug paclitaxel combined with neutral and positive lipids. The positively charged lipids mean that EndoTAG®-1 interacts with newly developed, negatively charged endothelial cells, which are primarily required for the growth of tumor blood vessels. The EndoTAG®-1 paclitaxel component attacks the endothelial cells as they divide, thus targeting the blood supply to tumors without affecting the supply to healthy tissue. By doing this, EndoTAG®-1 is expected to prevent the formation of new tumor blood vessels and to inhibit tumor growth. Compared to tumor cells, endothelial cells are genetically stable. Medigene assumes that due to this characteristic, EndoTAG®-1 can be used in the targeted treatment of those tumors that have already developed a resistance to conventional paclitaxel therapy.

Medigene has successfully provided proof of concept of EndoTAG®-1 in two clinical trials. A controlled phase II clinical trial for pancreatic cancer showed significantly increased survival rates of those patients treated with EndoTAG®-1 and gemcitabine combination therapy. A phase II trial in triple negative breast cancer also showed a positive efficacy trend of EndoTAG®-1 combination therapy. European and US authorities have granted orphan drug status for EndoTAG®-1 in the treatment of pancreatic cancer. This status affords benefits in the development, approval and, under certain circumstances, the commercialization of the drug.

Outlook:

Medigene intends to enter into one or more partnerships for EndoTAG®-1 with pharmaceutical or biotech companies and envisages the partner or partners taking over the further development and future commercialization of the drug candidate.