Idogen in brief

Idogen is a Swedish biotechnology company based in Lund. The Idogen share has been listed on Spotlight Stock Market since the 12th of June 2015 under the ticker IDOGEN and is traded through banks and stockbrokers. 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 tissues. The term “tolerogenic” refers to the immune system’s selective tolerance of a specific pathogenic or immune activating antigen following treatment with Idogen’s therapy. Idogen’s intention is to revolutionise the treatment of several disorders in which the body’s immune system does not function as it should, and for which there is a major unmet medical need – such as in autoimmune diseases, organ transplant rejection and in patients who have developed anti-drug antibodies.

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 also develops IDO T – a tolerogenic cell therapy to prevent organ transplant rejection, primarily kidney transplant rejection. IDO T is expected to reduce the need for immunosuppressive drugs and improve transplant survival, thereby reducing the risk of cancer and infections.

IDO 8 – treatment of antibodies against factor VIII in Haemophilia A

IDO 8 is Idogen’s most advanced project, aimed at developing a tolerogenic cell therapy for patients with severe haemophilia A who have developed inhibitory antibodies against their standard treatment. Idogen´s treatment has the potential to restore the original efficacy of factor VIII treatment. The company has chosen haemophilia A as its first indication due to the major unmet medical need of these patients and because the disease has a well-defined antigen, presenting an opportunity to develop an effective treatment for this patient group. Haemophilia A is a rare disease and Idogen has been granted Orphan Drug Designation in Europe for the treatment – a key value-adding step for the company since orphan drug designation provides several advantages, such as less extensive requirements for clinical trials, scientific guidance from the regulator during development and ten-year market exclusivity after launch.

The company expects the first clinical trial to commence in the beginning of 2020 and has had constructive scientific discussions with the Swedish Medical Products Agency (MPA) regarding the design of the study.

IDO T- prevention of organ rejection in kidney transplantation

The same method that is currently under development for the treatment of haemophilia A can also be used for other indications with only minor adjustments of the production process. The company has therefore made a strategic decision to commence parallel development of a product candidate for kidney transplantation, IDO T. The basic principle is to “teach” the patient’s immune system to recognise and accept the transplanted organ rather than attack it. This could eventually reduce the need for current methods of often lifelong treatment with drugs that inhibit immune system functionality. There is a major unmet need for long-acting, cost-effective and safe treatment to avoid the risk of transplant rejection.

Preclinical development for IDO T is ongoing with the aim of commencing a Phase I/IIa clinical trial starting earliest in the end of 2020.

Idogen’s first product, IDO 8, will treat patients with severe hemophilia A affected by neutralising antibodies against its vital coagulation factor VIII-treatment