After a somewhat shaky start to the year with adversities in the company’s cell therapy project, Idogen now seems to have turned the ship around and yet again be on a steady course ahead. The company has successfully replaced the missing subcomponent in its treatment concept and established a new method. In addition, a new CEO, Anders Karlsson, has been recruited with solid international life science experience from both the major pharmaceutical company Novartis and listed companies within medtech. BioStock has reached out to Karlsson to hear more about his views on Idogen’s goals and future.

Idogen develops tolerogenic cell therapies based on dendritic cells. These cells are a type of white blood cell that controls the actions of other immune cells against both endogenous and unknown molecules. Simply put, one can say that the goal is to teach the body’s immune system to distinguish “good” from “evil.”

At present, Idogen has three focus areas: hemophilia, organ rejection after transplantation (mainly kidney transplants) and autoimmune diseases.

The patient’s own cells are used

The word tolerogen means that the treatment teaches the immune system to tolerate a selected disease or rejection-causing, immune system activating, antigen. The goal is to create a therapy with tolerogenic dendritic cells from the patient’s own blood and then treat the dendritic cells outside of the body, among other things, with tolerance inducers and, to make the treatment unique and effective, disease-specific antigens.

Next, the now tolerogenic dendritic cells are injected back into the patient. This therapy, in the form of the reprogrammed cells, should now have the capacity to affect the immune system and thus counteract harmful immunological responses.

Tough start to the year

2019 started with a backlash for Idogen when the intended tolerance inducer zebularin, which was a subcomponent in the therapy preparation, didn’t produce the effect on human immune cells as previously indicated by preclinical studies.

Idogen’s research team therefore quickly shifted focus to identify a new tolerance inducer and the initiation of clinical trials was postponed.

On the way to clinical trials with a new method

In June, no more than five months later, Idogen was able to announce that the systematic work on finding a new tolerance inducer had borne fruit. After carefully evaluating a range of tolerance inducers, the company managed, through solid and intensive work, to identify a new method for developing tolerogenic cell therapy projects in the areas of hemophilia (IDO 8), kidney transplantation (IDO T) and autoimmune diseases (IDO AID).

The new method is based on a combination of tolerance-inducing substances that replace zebularine. This means that Idogen again can focus on the next step in development – clinical studies.

Experienced new CEO at the helm of the company

The new development method was not the only big news from Idogen during the summer. In July, Anders Karlsson was recruited as new CEO.

The recruitment means that Idogen is now armed with a new CEO with long and solid experience in international life science from both pharmaceutical companies and the medtech industry. With his strong background in economics, Karlsson could be defined as a specialist in market economy, and he has held leading positions in, among others, Novartis and Olerup International. His most recent assignment was as a CEO of listed Allenex where he, for example, led the merger with CareDx – a San Francisco-based company listed on Nasdaq in the US.

In addition, Idogen’s newly appointed CEO has experience in positioning companies and negotiating global cooperation agreements – experiences that should benefit Idogen in the company’s future development.

Karlsson’s long experience was particularly emphasized by Idogen’s Chairman of the Board Agneta Edberg in connection with the announcement of the recruitment:

»We are very pleased with the recruitment of Anders Karlsson. His combined experience from both the pharmaceutical and medical technology industry and his recognized leadership ability will be very valuable to Idogen. Anders has a strong business focus and has repeatedly contributed to large value increases in companies. We on the board look forward to continuing to develop Idogen together with Anders«

BioStock has taken the opportunity to talk to Anders Karlsson about how he views his new role and the future development of Idogen.

Anders Karlsson, you have a long experience from the life science and medical technology industry and on August 19 you were recruited as the new CEO at Idogen. Can you tell us more about your past work experience?

Anders Karlsson, CEO

– I have worked in commercial roles in life science for virtually my entire professional life, driven by working with products that help patients achieve better health and better lives. Since becoming CEO and Country President of Novartis in Norway in 2003, I have been CEO of several companies, where a common denominator has been transplantation and immunology.

In what way can you use your past experience in working with Idogen?

– My experience in immunology is of great value. We have a number of decisions that will be made in the coming months and together with a competent management we will advance our positions. It also feels nice to return to the pulse on the stock exchange.

What made you want to say yes to becoming CEO of Idogen?

– Idogen’s groundbreaking development project can be transformed into life-saving treatments for many seriously ill patients in the future. I have worked a lot in these areas over the years and know how great the need is, while it is clear that advanced techniques are needed to reach the next breakthrough, and there I see great potential in Idogen’s technology. I am also impressed by the efforts made by the research team during the spring, which requires great expertise and efficiency in order to be able to find new solutions so quickly, which bodes well for the future development.

What are your thoughts on the company’s three focus areas?

– All three indications are areas where there is a great need for new therapies and where many patients are waiting for the next breakthrough. It makes us very motivated in our work. Now we are completely focused on hemophilia and IDO 8 during the first part of the year. We will resume work on the other areas in the coming year.

At the beginning of the year, the company faced a major challenge as the then tolerance inducer did not produce the desired effect. That challenge has now been solved successfully, but what would you say is Idogen’s biggest challenge right now?

– Our focus now is to take our first project to clinical trial and show good effect in patients there. An important milestone is also to secure patent protection for the newly developed tolerance inducer. We also begin planning for the manufacturing of the therapies that we will use in our clinical trials.

This summer you announced that, after an initial intellectual property evaluation, the process of applying for a patent for the new method had begun. Can you guide us through this process? How far have you come in the patent application process and what protection do you currently have?

– This process is ongoing in close cooperation between our development department and patent law experts. It is important to point out that the new patents can give us a significant extension of market exclusivity, until 2039. This is because the clock does not start ticking until the patent applications are filed. The patent for the tolerance inducer that we used earlier expires as early as 2027. This, of course, further strengthens Idogen’s attractiveness and position in the market.

Patent processes and laws look different in different markets. Can you say something about what your patent strategies look like for your intended markets?

– We have previously worked with a broad geographical protection and we intend to do so for the new patent protection as well.

Idogen has previously announced plans to switch from Spotlight Stock Market to Nasdaq First North. Is a list change still relevant, and, if so, what progress has been made?

– We have been preparing the company for a move to Nasdaq First North for a long time, but in order to move forward we first needed to solve the problem of finding a new and effective tolerance inducer. Now that we have succeeded in doing so, a list change is again highly prioritized. However, a practical detail is that the company’s CEO must have at least 3 months in his role in the company before a move can become relevant.

Clinical studies are expensive, what does Idogen’s financial situation look like for the upcoming development steps?

– We have funding for operations with the current organization and activity level up to Q3 2020, which gives us plenty of time to prepare for clinical studies. If we receive the payments that are likely from Horizon 2020, the cash will last another three months.

The company has been granted EUR 2.9 million from Horizon2020, the EU’s framework program for research and innovation, for the development of a treatment for severely hemophiliac patients. The grant is paid out in installments. Have you received all payments or are you expecting more money from Horizon?

– We have so far received about half of the funds allocated. We anticipate that most of the remaining funds will be disbursed over the next 24 months.

Finally, where do you anticipate Idogen will be in one and three years, respectively?

– In a year, we have come a long way towards our first clinical trial. In three years, the hope is that we have shown good results not only from one of our projects, but also been able to apply our technology platform to other indications with good results.

Published by BioStock 2019-09-09