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Idogen submits clinical trial application


Idogen submits clinical trial application

21 December, 2021

Last week, biotech company Idogen submitted a clinical trial application to the Swedish Medical Products Agency to initiate a clinical phase I/IIa study with the cell therapy IDO 8 in patients with haemophilia A who have developed antibodies to their treatment. Once the application has been reviewed and approved, the study can be initiated, which is expected to be in the second quarter of 2022. In order to finance the upcoming study, Idogen will be carrying out a rights issue of approximately 50.4 MSEK.

Idogen develops tolerogenic cell therapies for the treatment of unwanted activation of the immune system.The company’s most advanced cell therapy is IDO 8. It is developed to create tolerance to factor VIII and thus enable ongoing substitution treatment with clotting factor VIII – a vital treatment for haemophilia A – despite the fact that some patients develop neutralising antibodies that remove the treatment effect.

The company’s second project, IDO T, is intended to prevent kidney transplant rejection. The third project, IDO AID, targets severe, and in many cases rare, autoimmune diseases, i.e. diseases where the immune system has become the body’s own enemy.

First-in-Human study with IDO 8 in 2022 

Idogen’s cell therapy is based on the patient’s own cells and is tailored for each individual patient in a GMP-certified laboratory at the company’s manufacturing partner Radboud University Medical Center in the Netherlands. During the fall, Radboud has successfully optimized the production process to increase the antigen levels, a very important component of IDO 8. The company is now ready to take the project into a clinical phase I/IIa study in patients with severe haemophilia A who completely lack FVIII and who have developed antibodies against their substitution treatment with FVIII.

A clinical trial application was recently submitted to the Swedish Medical Products Agency, which is a big step for the company according to CEO Anders Karlsson:

»We are now taking a much-desired step towards the clinical development of IDO 8 for patients who are in need of a means of successfully continuing their treatment for hemophilia even in a situation where FVIII reactive antibodies have been developed. The application is a result of our solid preclinical research efforts and successful work in scaling up our manufacturing process from laboratory scale to industrial scale and to a treatment to be used in the clinical trial.«

Evaluation of safety and preliminary clinical treatment effect

The aim of the study, which is the first time Idogen’s cell therapy will be used in humans, is to evaluate thesafety of IDO 8 and obtain preliminary results regarding the effect of treatment. At the end of the study, patients will be given FVIII to see if the immune system tolerates the treatment. If it does, it means that IDO 8 has created a protection against the formation of inhibitory antibodies, thus succeeding in re-inducing the effect of the vital FVIII treatment.

Securing financing for clinical phase through rights issue

In order to finance the clinical trial with IDO 8, Idogen will carry out a rights issue of units, consisting of shares and warrants. Upon full subscription in the rights issue, Idogen will initially receive approximately 50.4 MSEK before issue costs. If all warrants are fully exercised for conversion into shares, Idogen will receive additional proceeds of 42.0 MSEK before issue costs.

The capital will primarily finance the clinical study with IDO 8, as well as the preclinical preparations for a clinical study with IDO T project. The company intends to apply for the IDO T study approval by the end of 2023. 

ODD facilitates clinical development and commercialisation

Idogen has chosen haemophilia A as the first indication due to the major unmet medical need of these patients and because the disease has a well-defined antigen, giving great possibilities to develop an effective treatment according to the company. Haemophilia A is a rare disease and Idogen has thus been granted Orphan Drug Designation in Europe for IDO 8. This designation brings a number of benefits, such as less extensive requirements for clinical trials, authority guidance throughout the development process and market exclusivity upon launch (10 years in the EU and 7 years in the US).

Over the years, Idogen has put many important pieces of the puzzle in place for the development of IDO 8. Now, the company is looking forward to 2022, the year when they are expected to enter the clinical phase.

The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.

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