Idogen has reached milestone in clinical trial preparations
Idogen has optimised the GMP manufacturing process in order to maximise the treatment effect of the cell therapy IDO 8 in patients with haemophilia A. The extensive optimisation work is now completed and Idogen is thus approaching the first clinical study with IDO 8. The company is about to submit a clinical trial application to the Medical Products Agency and plans to initiate the study during the second quarter of 2022.
Biotech company Idogen develops tolerogenic cell therapies against diseases and conditions in which the immune system has become the body’s own enemy. The cell therapies are intended to prevent the immune system from attacking biological drugs, transplanted organs or the body’s own cells.
The first candidate, IDO 8, targets patients with haemophilia A who have developed antibodies to their vital FVIII treatment, i.e. the coagulation factor that is missing in the patients’ blood. The company’s second candidate, IDO T, is being developed to prevent rejection of transplanted kidneys. With IDO AID, the company’s third development programme, Idogen focus on the treatment of autoimmune diseases.
Successful collaboration with Radboud University Medical Center
In 2019, Idogen signed a collaboration agreement with Radboud University Medical Center (RUMC) in the Netherlands, a world-leading manufacturer of cell therapies. Since then, RUMC has established and scaled up the production of Idogen’s cell therapy. These were crucial steps to prepare for the clinical trial with IDO8.
During the autumn, RUMC has further optimised the manufacturing process, in close collaboration with Idogen. The antigen levels in IDO 8 have been maximised to increase the likelihood of a desired treatment effect. In addition, RUMC has succeeded in achieving product characteristics with IDO 8 that are equivalent to what was demonstrated in Idogen’s research laboratory. Looking forward, RUMC is eager to continue its quest with Idogen to developing a new treatment concept with the potential to help a large number of haemophilia patients:
»IDO 8 has shown very promising properties in preclinical studies and it is a great success that we can now, in a reproducible way, manufacture this unique tolerogenic cell therapy on a larger scale in order to be able start of the clinical trial program. The IDO 8 project has thus taken another significant step forward and we look forward to contributing to Idogen’s continued work to create a medical solution to the problem of neutralizing antibodies to coagulation factor VIII« – Professor Jolanda de Vries, RUMC
Will start a clinical study with IDO 8 in 2022
With the project, Idogen is addressing a major medical problem – FVIII antibodies. Approximately 30 per cent of all patients with haemophilia A treated with FVIII eventually develop inhibitory antibodies to the added coagulation factor, making the treatment ineffective. Out of these, about a third do not respond to the current tolerance inducing treatment. It is this patient group that will be included in Idogen’s upcoming phase I/II clinical trial, with the objective to evaluate the safety profile of IDO 8 in patients, identify an appropriate dose regimen, and evaluate the treatment effect.
However, before the clinical study with IDO 8 can begin, Idogen needs to submit a clinical trial application (CTA) to the Medical Products Agency and other relevant authorities, which they plan to do before the turn of the year. Thereafter, the company expects to be able to start the study in the second quarter of 2022, provided that the necessary regulatory approvals are obtained.
Idogen’s tailor-made cell therapy – a potential breakthrough in haemophilia
The cell therapy will be tailored for each patient in a GMP-certified laboratory at RUMC. The fact that the treatment is tailored means that it is based on the patient’s own cells, differentiated into “programmed” dendritic cells using Idogen’s unique tolerance inducers and the specific antigen that the body should learn to tolerate. This is expected to counteract the harmful immune response and induce immunological tolerance.
According to the company’s CEO Anders Karlsson, the extensive optimisation work has resulted in IDO 8 being upgraded in a way that significantly increases the potential to obtain a good treatment effect.
The ambition is that IDO 8 will prevent the immune system from developing antibodies to FVIII, which will allow the patient to be treated again with FVIII without the immune system reacting and disabling the coagulation factor. This would be a major breakthrough in haemophilia, according to a previous interview in BioStock with Professor Rolf Ljung.
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.
