Future and Strategy

Idogen’s intention is to enter into commercial license agreements based on the clinical trial results in each development program. In recent years, a number of smaller cell therapy companies have signed commercial license agreements with global pharmaceutical companies under attractive terms.

Cell therapies are a recent addition to treatments for severe diseases and to date a handful of therapies have already made it all the way to becoming a marketed product. A highly promising cell therapy developed by Novartis, one of the largest pharmaceutical companies in the world, was approved for the treatment of cancer in the US in 2017 and Europe in 2018. The approval is regarded as an historic milestone for the establishment of cell therapies, reducing uncertainty among those investors who were previously doubtful about this area. Idogen has analyzed the European market and conducted a survey of the US market regarding potential products that could be developed using our platform for tolerogenic cell therapy. The company is of the opinion that there is a great potential market for the treatment of hemophilia A patients who have developed inhibitors against factor VIII, since current treatment guidelines in North America and Europe still recommend inducing tolerance for the first-line treatment with factor VIII. The potential is even greater in kidney transplantation, since over 11,000 patients yearly receive transplants from living donors at Idogen’s addressable markets for tolerogenic cell therapy.

At present, there are already several established regulatory programs whose purpose is to speed up the development and time to market of new treatments with substantial medical potential for patients. One initiative is PRIME (priority medicines), which was launched by the European Medicines Agency (EMA) in 2016. Another is accelerated approval at the FDA, which entails early market approval for pharmaceutical candidates that demonstrate promising results from treating seriously ill patients who have no other treatment alternatives. The company’s ambition is to evaluate these regulatory opportunities in parallel with completion of the first clinical trial of IDO 8.

Idogen was awarded research funding of MEUR 2.9 by Horizon 2020 (the EU Framework Programme for Research and Innovation), for development of the company’s tolero­genic cell therapy for the treatment of patients suffering from severe hemophilia. The EU grant SME Instrument Phase 2 has the overarching target of conducting pre­clinical safety studies, creating processes for manufacturing tolerogenic cell therapy for clinical trials and conducting the first phase 1/2a clinical trial in patients with hemophilia A and neutralizing antibodies against factor VIII. Idogen was awarded the grant in intense competition with other companies, which is proof of the company’s quality, and the grant has been a vital contribution in financing the development of the product candidate IDO 8.