Idogen reports positive pre-clinical results
Idogen AB (”Idogen”) initiated in the autumn of 2015 a pre-clinical ”proof-of-concept”-study of the company’s cell therapy in a model of hemophilia A. The results of the study show that treatment with tolerogenic dendritic cells results in a reduced occurrence of inhibitory factor VIII antibodies and has a long-lasting effect. If the method can be transferred to humans it means that tolerogenic vaccine can provide protection against the formation of inhibitory antibodies following repeated treatment with factor VIII in patients with hemophilia A.
The ”proof-of-concept”-study was initiated after a consultative meeting with the EMA before a planned application for orphan drug designation. The hemophilia model used is based on immunization with human coagulation factor VIII in rats and subsequent treatment with autologous zebularine-treated dendritic cells. The results show that Idogen’s treatment with tolerogenic dendritic cells have achieved a statistically significant difference in the occurrence of inhibitory factor VIII antibodies as compared to the control group. The treatment has a long-lasting effect and a delay to established effect ‒ in line with the existing method to achieve tolerance in hemophilia patients who have developed inhibitory antibodies. If the method can be transferred to humans it means that treatment with tolerogenic vaccine provides protection against the formation of inhibitory antibodies in hemophilia patients. These positive”proof-of concept”-data will be included in the application for orphan drug designation the company plans to submit later this year.
”It is with pleasure that we can report the results of our ”proof-of-concept”-study and conclude that Idogen’s tolerogenic vaccine seems to reduce the occurrence of inhibitory factor VIII-antibodies in an animal model of hemophilia A, which is a great success for us. Interestingly is especially that the effect persists long after treatment”, comments CEO Lars Hedbys.
For additional information, please contact:
Lars Hedbys, CEO
Tel: +46 - 46 - 275 63 30
E-mail: lars.hedbys@idogen.com
Idogen develops tolerogenic vaccines which reprogrammes the immune system. The term "tolerogenic" refers to that the immune system will tolerate the selected molecule after treatment. It represents a new treatment method for autoimmune diseases, organ rejection after transplantation and patients without treatment after developing antibodies against standard treatment. The first indication for the therapy will be patients with the bleeding disorder hemophilia A who have developed an immunological reaction against their necessary factor VIII replacement.
The treatment method comprise that cells from the patient's blood are reprogrammed to dendritic cells with capacity to specifically counteract the adverse immune reaction. The company's platform technology has the potential to develop long-acting treatment of anti-drug antibodies as well as autoimmune diseases that currently can not be cured. In addition, Idogen has the potential to change the transplantation market by reducing the need for immunosuppressive therapy after transplantation. Idogen was founded in 2008 based on a fundamental immunological discovery at Lund University. For more information, visit www.idogen.com