Idogen signs agreement with global contract research partner
Idogen AB (”Idogen”) today announces that the company has signed an agreement with Advinus Therapeutics, a leading global contract research organization, for synthesis of zebularine for future pre-clinical and clinical trials. Zebularine is a key component in Idogen’s tolerogenic vaccine. The agreement means that zebularine will be synthesized according to current regulations for GMP (”Good Manufacturing Practice”). This represents an important step taken by Idogen towards a product for clinical trials.
Idogen is starting cooperation to synthesis the company’s drug candidate zebularine in accordance with current regulations for pharmaceuticals (GMP), with a leading global contract researcher. Zebularine in GMP-quality is required for preclinical safety studies of the company’s tolerogenic dendritic cells and for the upcoming clinical trial, which the company estimates to commence during 2018. Idogen has performed an on-site quality audit at Advinus and ensured that the necessary regulatory requirements are fulfilled.
”The successful proof-of-concept-study in human cells, together with the recent timely financing event, we are now taking another step toward being able to produce our tolerogenic vaccine. Having the agreement ready for GMP synthesis of zebularine means that we are adhering to the communicated schedule for the development toward clinical trials and treatment of patients with severe hemophilia A and antibodies to factor VIII.”, CEO Lars Hedbys comments.
Advinus is a Contract Research Organization (CRO) with a wide range of services, in the areas of preclinical toxicology testing, chemical process development, analytical R&D, drug metabolism and pharmacokinetics for pharmaceutical and biotechnology industries. The company has over 24 years of experience of studies performed in accordance with global regulations for pharmaceutical development. For additional information about Advinus Therapeutics, see www.advinus.com.
For additional information about Idogen, please contact:
Lars Hedbys, CEO
Tel: +46 (0)46-275 63 30
This is an English version of an original Swedish press release communicated by Idogen AB. In case of interpretation issues or possible differences between the different versions, the Swedish version shall apply. This constitutes information that Idogen AB is required to publish under the EU’s Market Abuse Regulation. The information was submitted for publication through the above contact person on the 21st of November 2016.
Idogen develops tolerogenic vaccines which re-program 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 comprises cells from the patient's blood being reprogrammed to dendritic cells with the capacity to specifically counteract the adverse immune reaction. The company's technology platform has the potential to develop long-acting treatment of anti-drug antibodies as well as autoimmune diseases that currently cannot 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