Idogen’s cell technology successfully advanced to large-scale production
Idogen AB (Spotlight Stock Market: IDOGEN) has today announced that the company’s technology platform for tolerogenic dendritic cell generation has been successfully advanced from pilot to production-scale. Results from completed tests show that the technology platform can now generate functional cells in considerably larger volumes than previously possible. As the next step, Idogen now initiates the partnership with Radboud University Medical Center in the Netherlands, to establish cell production meeting Good Manufacturing Practice (GMP) requirements prior to upcoming clinical trials.
Idogen’s tolerogenic cell therapy is based on dendritic cells, a type of white blood cell that plays a key role in the immune system by controlling the response of other immune cells to the body’s own and foreign molecules and tissues. The company’s most advanced project, IDO 8, is designed to restore the efficacy of haemophilia drugs in patients who have developed neutralising antibodies. The IDO T project is being developed to prevent kidney transplant rejection.
Recently, Idogen has successfully evaluated and documented a range of methods for scaling up the company’s production. That is creating flexibility prior to selection of the method to be used for manufacturing the materials for the planned clinical trials for the company’s cell therapy projects. All of the methods are compatible with the GMP-certified production system that is available from the company’s partner, the Radboud University Medical Center.
“The fact we have now been able to show the scalability in the generation of our cell therapy products is a major success because it significantly reduces the level of risk in our projects. Our partner, Radboud University, is a global leader in the field and will assist us in our ongoing efforts to establish a GMP-certified manufacturing process prior to starting clinical trials,” says Hanne Risager Romedahl, Chief Scientific Officer at Idogen.
For further information, please contact:
Anders Karlsson, CEO, Idogen AB
Tel: +46 70 918 00 10
E-mail: anders.karlsson@idogen.com
Idogen (Spotlight Stock Market: IDOGEN) develops tolerogenic cell therapies to prevent the patient’s immune system from attacking biological agents, transplanted organs or the body’s own cells or tissue. Idogen’s most advanced product candidate IDO 8 is designed for patients with severe haemophilia A who have developed anti-drug antibodies against their critical treatment with coagulation factor VIII (factor VIII). The company´s second project IDO T is developed to prevent kidney transplant rejection. In a third project, IDO AID, Idogen focuses on the treatment of autoimmune diseases. The treatment is based on the patient's own cells and is expected to have a favorable safety profile and long-lasting effect. The fact that a short treatment has the potential to yield a long-lasting effect is another great advantage. For more information, visit www.idogen.com