Idogen receives approval from the Norwegian Medicines Agency, NoMA, for the start of its clinical phase 1/2a study with IDO 8

Idogen AB (publ) has received approval from the Norwegian Medicines Agency, NoMA, to begin recruitment    for its clinical phase 1/2a study with IDO 8, a completely new type of cell therapy for patients with severe hemophilia A who have developed antibodies to their treatment with coagulation factor VIII.

The Swedish Medical Product Agency has already previously approved the phase 1/2a study and patient recruitment in Sweden will begin as soon as the authority has formally approved the local trial center where the study is to be carried out. The approval from NoMA now gives the go-ahead to start patient recruitment in Norway as well. The plan is for the study to be carried out in several European countries.

“It is tremendously gratifying that we now also have an approval from the NoMA for our phase 1/2a study. This application concerns Oslo University Hospital, which is a leading center and very reputable for the treatment of patients with severe hemophilia A. We have initiated a collaboration with Professor Pål Andre Holme, senior consultant at the university hospital and who has been involved in our application to NoMA.  Professor Holme is now taking on the role of principle investigator in Norway,”says Hanjing Xie, Chief Medical Officer at Idogen and responsible for conducting the study.

Idogen's cell therapy IDO 8 is tailored for each individual patient in a GMP-certified facility at the company's Dutch manufacturing partner Radboud University Medical Center (RUMC). The study has been designed in dialogue with the regulatory authorities in the Nordic countries and the goal is to evaluate the safety of IDO 8 and to follow signals of treatment effect in patients.

For further information, please contact:

Anders Karlsson, CEO, Idogen AB

Phone: +46 70 918 00 10

Email: anders.karlsson@idogen.com

Certified Adviser:
Erik Penser Bank AB, Box 7405, 103 91 Stockholm
Phone: +46 (0)8-463 80 00
Email: certifiedadviser@penser.se

The information was submitted for publication, through the agency of the contact persons set out above, on 11 April 2022 at 08.53 CET.

The English text is an unofficial translation of the original Swedish text. In case of any discrepancies between the Swedish text and the English translation, the Swedish text shall prevail.

Idogen (Nasdaq First Growth 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. The company’s most advanced project, IDO 8, is designed to restore the efficacy of hemophilia drugs in patients who have developed neutralizing antibodies. The company’s second project, IDO T, is being developed to prevent kidney transplant rejection. In a third programme, IDO AID, Idogen is focused on the treatment of autoimmune diseases. The treatment for all indications is based on the patient's own cells and is expected to have a favorable safety profile and long-lasting effect. The potential for a short-term treatment intervention to yield a long-term effect is a major advantage in health economics for both patients and divisions providing care. More information about Idogen is available via https://www.idogen.com