The evaluation of the efficacy study in a preclinical model of chronic lymphocytic leukemia is mainly based on analyses of cells using flow cytometry, protein analysis, and an analysis of possible side effects. Analyses of cells by flow cytometry have been carried out on human cancer cells which were administered to the animals. The results show that the number of human leukemia cells and ROR-bearing cells has been reduced by approximately 75% after seven days of daily oral administration of 40 mg/kg of KAN0439834. Protein analysis was carried out with the help of markers of ROR1-activation in cancer cells as well as apoptosis (cellular suicide). The results of the protein analysis show that the animals that were treated with 40 mg/kg of KAN0439834 orally per day have reduced ROR1 activity and an increase of apoptosis. Tolerance studies show that healthy cells from the spleen are not affected by treatment with KAN0439834 at the dose used, supporting that the effect of this substance is mainly directed against cancer cells. A clinical chemistry analysis of 17 markers in the blood of treated animals shows an indication of some side effect from one of these markers. This marker is a sensitive indicator of effect on liver that previously has shown response after intake of certain foods and approved drugs. This liver marker will be monitored as part of the further drug development of KAN0439834.
Taken together, the findings support Kancera’s selection of KAN0439834 as the first candidate drug in the ROR project. The development is now focused on new technologies for oral administration of KAN0439834 and further preclinical studies of efficacy and tolerance in animal models of several cancer diseases.
About the ROR project
ROR is a family of receptors, ROR1 and ROR2. The ROR receptors mediate signals for growth and survival. Originally ROR was linked to fetal development, but it is now known that they also contribute to cancer cell development and proliferation. Professor Håkan Mellstedt, Kancera´s co-founder and professor at the Karolinska Institute, and his colleagues have shown that Kancera´s ROR inhibitors have the ability to kill cells from tumors in pancreas, and leukemia cells. Professor Mellstedt and his colleagues as well as independent researchers have shown that ROR is also active as a target in prostate, breast, skin and lung cancer.
Because ROR primarily generates a survival and growth signal to tumor cells but is inactive in healthy cells in adults, there are good prospects that a drug directed against ROR hit the tumor much harder than the surrounding healthy cells. Kancera and Professor Mellstedt have shown that inhibition of ROR leads to that cancer cells eliminate themselves by cellular suicide. Against this background, there are reasons to anticipate that a ROR-targeted drug is both safer and more effective than several chemotherapies currently used to treat cancer.
About Kancera AB (publ)
Kancera develops the basis for new therapeutics, starting with new treatment concepts and ending with the sale of a drug candidate to international pharmaceutical companies. Kancera is currently developing drugs for the treatment of leukemia and solid tumors, based on blocking survival signals in the cancer cell and on addressing cancer metabolism. Kancera’s operations are based in the Karolinska Institutet Science Park in Stockholm and the company employs around 10 people. Kancera shares are traded on NASDAQ OMX First North and are held by around 6300 shareholders as of September 30, 2014. Remium Nordic AB is Kancera’s Certified Adviser. Professor Carl-Henrik Heldin and Professor Håkan Mellstedt are board members and Kancera´s scientific advisers.
For additional information, please contact:
Thomas Olin, CEO: Tel +46 735 20 40 01
Karolinska Institutet Science Park
SE 171 48 Solna,Sweden
Please visit the company’s web www.kancera.com