Idogen develops tolerogenic cell therapies for diseases and conditions where the immune system has become the body's own enemy. The goal of the cell therapies is to prevent the unwanted activation of the immune system.
The company's most advanced cell therapy project IDO 8 aims to restore the effect of the life-saving treatment with coagulation factor VIII (FVIII) in hemophilia A, the most common form of bleeding disorder. Approximately one third of patients develop antibodies to the FVIII treatment, making it ineffective. Idogen wants to change this with IDO 8, which will create tolerance to FVIII and thus enable continued treatment.
Green light for phase I/IIa study with IDO 8
During the second quarter, Idogen plans to initiate a clinical phase I/II study with IDO 8, where the goal is to evaluate safety and monitor signals of treatment effect in patients. In March, the company received approval from the Swedish Medicines Agency to initiate the study – see BioStock's interview with Anders KarlssonNow the Norwegian Medicines Agency has also NoMA, has given the go-ahead to begin patient recruitment for the study.
Idogen intends to conduct the study in more countries than Sweden and Norway and is in dialogue with several European trial centers regarding this.
Idogen's cell therapy to be tested on patients for the first time
The upcoming Phase I/IIa study is a so-called First-in-Human study where IDO 8 will be tested in patients for the first time. The study design has been developed in dialogue with the regulatory authorities in the Nordic region and leading specialists in the field. The study will include nine hemophilia A patients with antibodies to the standard treatment with FVIII.
An initial follow-up will be conducted 26 weeks after the patient has received their treatment. In addition, a long-term follow-up will be conducted after 52 weeks. Three different doses will be evaluated for safety, but also preliminary clinical efficacy.
The effect that is desired to be achieved with IDO 8 is to extinguish the immune response to the FVIII treatment so that the antibody reaction disappears, which would allow the patient to be treated with factor concentrate again. Read more about the expectations of IDO8's effect in BioStock's interview with professor Jan Astermark, principal investigator in the clinical study with IDO 8.
Collaboration agreement with two CROs
The study is expected to last during 2022-2023 and will be conducted together with Klifo and 4Pharma, two contract research organizations (CROs) with extensive experience in drug development. The collaboration agreements were signed in March and apply to all trial centers in Europe where Idogen intends to conduct the study.
Strengthens the organization ahead of the start of the study
To strengthen the organization ahead of the clinical development phase, Idogen has recruited three new employees – Hanjing Xie as CMO, Rory Graham as CRO and Martina Johannesson to the role of Program Manager Cell Therapy.
Hanjing Xie, who most recently came from a role as Senior Medical Study Director at Oncopeptides, will be responsible for the clinical development of IDO 8. Rory Graham, with extensive experience in regulatory processes in Europe and the US, will continue the regulatory work with IDO 8 and further applications prior to the start of the Phase I/IIa study.
Martina Johannesson, who most recently came from the stem cell company Amniotic, will ensure the coordination and implementation of the IDO 8 project, as well as the development program for IDO T which aims to reduce the risk of organ rejection in kidney transplantation.
A strengthened organization, as well as study approval in both Sweden and Norway, bodes well for exciting months ahead for Idogen.