We are very pleased that the positive discussions we have had with clinical experts in Norway have now resulted in the intention to participate in our first clinical study with IDO 8. This is another important and long-awaited step to enable effective treatment of patients with severe hemophilia A and who have developed neutralizing antibodies to their vital treatment
The extensive optimization work carried out during the autumn has resulted in our cell therapy IDO 8 being upgraded in a way that we believe significantly increases the possibilities to obtain a good treatment effect. We will shortly submit our application to the Medical Products Agency for the first clinical study for IDO 8, which is planned to start during the second quarter of 2022
The fact that we are now approaching the first clinical trial is therefore not only inspiring from the perspective that our technology will at last be evaluated in use with patients, but also entails a significantly stronger base for our business development.
Tolerogenic cell therapy has the potential to improve and prolong the life of many patients with immune driven conditions and diseases. Idogen aims to play a key role in the rapid development that is taking place in the field.
We are very happy to receive this very positive news confirming the patent grant from the European Patent Office. The patent protects Idogen´s technology to prevent the production by the immune system of neutralizing (inhibiting) antibodies against treatment with blood factors such as Factor VIII (FVIII). This patent will provide additional protection and strengthen the company´s patent portfolio for IDO 8, for which we intend to initiate clinical studies during the second half of 2021
This patent will provide additional protection and strengthen the company´s patent portfolio for IDO 8, for which we intend to initiate clinical studies during the second half of 2021
Despite the effects of the coronavirus pandemic, which presented major challenges at global level as well as in the corridors of Idogen, we are now putting a highly eventful and productive year behind us. We are moving into 2021 with a stronger team than ever before since we during the year, have recruited several new experienced and competent employees for key positions in the company
”The rights issue proceeds will primarily finance three different focus areas: the safe start of the company’s first clinical study with IDO 8 in second half of 2021, accelerate the pace of development of Idogen’s treatment for organ rejection in transplantation, IDO T and increase the focus on commercial and academic partnerships”
It is satisfying that Idogens manufacturing partner has succeeded, despite its limited capacity during the COVID-19 pandemic, to establish a successful production process for our cell therapy. We have chosen to make a slight adjustment to the timelines of the project to ensure that we maintain the high standards imposed on quality in the remaining development work. The capacity-related delay at Radboud University Medical Center results in a delayed start to the clinical study, but we see good opportunities to shorten the time for patient recruitment by using several trial centers that operate in parallel. Our previous assessment was that the clinical study can be completed in December 2022 and at present we see good opportunities to complete it during the first quarter of 2023.
Idogen is continuing to develop positively and we are working at a rapid pace so that our unique tolerogenic cell therapy will be able to normalise lives for a number of patient groups whose current treatments leave a great deal to be desired
“It is widely known that the establishment of scalable production of cell therapy products is a major challenge, so we are therefore very pleased about the significant milestones we can announce today. We have now taken yet another important step on the path to the first clinical trial of IDO 8, which is expected to commence in the first half of 2021”
“The listing on Nasdaq First Growth Market is an external validation of the quality of Idogen’s corporate governance, internal procedures and financial information, and increases the Company’s visibility on the capital market. Through this, we hope to attract even more long-term owners who see the potential in our unique cell therapy projects,”
”The listing on Nasdaq First North Growth Market has been an important and prioritized target for Idogen in 2020 and we are happy that we today can announce that the Company fulfills all Nasdaq’s requirements and thus has obtained a conditional approval. Nasdaq is a global well-known brand that enables increased visibility in the stock market and facilitates institutional and international investors to become shareholders in the Company. I also want to take the opportunity to thank Spotlight Stock Market for good cooperation over the years”
“The feat of successfully raising capital in the prevailing stock market climate is proof of Idogen’s strength, and emphasises the confidence in our competence and the potential in our product portfolio”
The success of our systematic evaluation work means that we have been able to establish a significantly stronger method for the preparation of our tolerogenic cell therapy. The last few months have been a test of strength for the company's employees and with the promising results achieved we can now look back on our efforts with pride. We are now continuing the development of our projects at a fast pace
This study is an important step in the evaluation of a number of autoimmune diseases that we are now conducting and it is positive that we are able to achieve these results. The results represent an important piece of the puzzle in our analysis and will be compared with the additional work that is carried out in other autoimmune diseases and with other methods of administration
This patent provides very important protection for our tolerogenic cell therapy in Canada, the 10th largest pharmaceutical market globally and an important territory for innovative therapies such as ours. This patent family covers key components of our technology, together with its use and its products
The orphan drug designation in the United States means that we now receive support from the FDA during the development work and seven years of market exclusivity after launch. This facilitates further development and potential commercialization of our cell therapy, which targets a well-defined group of hemophilia patients in great need of improved treatment
We are very excited about the opportunity to evaluate the potential of Idogen's technology platform in the field of autoimmune diseases. Today, there is a major unmet medical need in patients with current standard treatments, where we believe that Idogen's tolerogenic cell therapy can play an important role. Our focus will be on one or several rare diseases, which allows for the grant of orphan drug designation that can reduce both development costs and time until market approval, as well as extended market exclusivity
The patent now granted provides strong intellectual property protection in the world's largest pharmaceutical market, thereby significantly increasing the commercial potential of our innovative tolerogenic immunotherapies
For Idogen, it is very pleasing and satisfying to be participating in the establishment of an internationally recognized center for cell- and gene therapy, together with large and small companies in the area, all Swedish universities and several healthcare providers. The collaboration is expected to contribute positively to the development of our tolerogenic vaccines, as it gives us easier and faster access to cell therapy expertise and becomes an important source of support for clinical development and production, logistics and commercialization
Cell- and gene therapy is a future area that provides the opportunity to cure or treat patients who currently lack treatment options, but in the long term also for major public diseases. We have recently seen significant investments internationally in the area, and it is an extremely important signal that Vinnova is now contributing to making Sweden a leader in the field with such an extensive venture. The unique thing in our granted project is that we create a broad collaboration in which academia, healthcare and small as well as large pharmaceutical companies jointly establish an internationally recognized cell and gene therapy center
We are very grateful and proud to be one of the few chosen in the tough competition for funding from Horizon 2020, SME Instrument. The fact that EU chooses to fund our project is an important confirmation of the potential of our vaccine technology.
Based on the three significant advances we have achieved in the past year with successful proof-of-concept in a model of hemophilia, results showing that we can influence parts of the human immune system in test tube experiments and our initiated transfer of the method to a GMP-customed process, we have great confidence in our technology. We have therefore decided on a more progressive development program with parallel development of tolerogenic vaccines within two different important therapeutic areas with need for a novel treatment regimen
I look forward to working with Idogen and hemophilia again – a patient group I’ve worked a lot with. Idogen has an interesting technology which can change the current treatment modality of medically very vulnerable patients and I think my previous experiences will be useful.
The granted patent in Europe is a significant endorsement. Idogen develops tolerogenic vaccines with high medical and commercial potential, and we have now secured patent protection for these methodologies in two major markets – Europe and Japan. We also have a Notice of Allowance issued in the USA
This patent provides very important protection for our tolerogenic vaccine platform in the USA. This is a key market representing 40% of the global pharmaceutical market and is important territory for innovative therapies such as ours. The decision that the USPTO will grant a patent gives us great encouragement
The granting of our patent application in Japan is pleasing and a statement representing a considerable strengthening of Idogen’s patent portfolio
This patent provides very important protection for our tolerogenic vaccine platform on the European market – a key market for us. The decision that the European Patent Office intends to grant the patent is very pleasing
As another major market for our tolerogenic vaccine is now added to the patent portfolio, our future prospects are strengthened. The decision represents a clear increase in the value of our product portfolio.
Big pharma companies have demonstrated interest in cell therapy and keep themselves updated on progress. To out-license part of the portfolio is a clear long-term strategy for Idogen.
The successful proof-of-concept-study in human cells, together with the recent timely financing event, we are now taking another step toward being able to produce our tolerogenic vaccine. Having the agreement ready for GMP synthesis of zebularine means that we are adhering to the communicated schedule for the development toward clinical trials and treatment of patients with severe hemophilia A and antibodies to factor VIII
The study shows that two of the follow-up molecules to Zebularine we have tested so far have a good treatment effect in a model of rheumatoid arthritis, which is very pleasing. This study confirms that we have interesting alternative candidates for new indications. The results strengthen the company’s platform and create important opportunities in the future to out-license projects in several indications
Our success in producing human tolerogenic dendritic cells is of major importance to us. We have previously demonstrated proof-of-concept in an animal model – now we have taken the next step and shown proof-of-concept in a study with human cells in vitro. This progress is an important milestone and means that the company has taken a major step towards a treatment method for patients with severe hemophilia A affected by neutralizing antibodies against their vital factor VIII
It is with pleasure that we can report the results of our ”proof-of-concept”-study and conclude that Idogen’s tolerogenic vaccine seems to reduce the occurrence of inhibitory factor VIII-antibodies in an animal model of hemophilia A, which is a great success for us. Interestingly is especially that the effect persists long after treatment