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Important progress for cell therapy

Idogen Lars Hedbys

Nordic Life Science asked Lars Hedbys, CEO of Idogen, about the potential and challenges for cell therapies.

For gene and cell therapies 2017 really was a breakthrough year. For example, there was an increasing interest in companies developing these therapies, like the recent news about Takeda’s intention to acquire TiGenix, a biopharma company developing novel stem cell therapies for serious medical conditions. In December last year the EMA CHMP adopted a positive opinion, recommending a marketing authorization for TiGenix’s leading investigational therapy Cx601 for this indication. An EMA decision on marketing authorization for Cx601 is expected in the first half of 2018, which will make this the first allogenic stem cell therapy to achieve marketing authorization.

Idogen is a Swedish company that develops tolerogenic cell therapies that re-program the immune system and represent a new treatment method for autoimmune diseases, organ rejection after transplantation and for patients having developed antibodies against treatment with biologics.

Idogen is involved in the Swedish innovation agency-financed project CAMP (Centre for Advanced Medical Products), which, among other things, will further develop new processes to characterize cells used for medical treatment, optimize the manufacturing processes and improve quality control and logistics. What can Idogen contribute with?

“CAMP will be important in consolidating the competence that is today scattered over different operators and places, and will also build up new knowledge. Idogen and the phase we are in right now is a good fit with what CAMP aims to achieve. We can offer a number of specific cases to learn from. As a company we could also contribute with profound experience from the different phases of pharma development, not least within authority requirements as well as understanding of the market.”

What is needed in order for the Nordic region to have a leading edge in this field?

“The Nordic countries have good competence in terms of development of pharmaceuticals, via AstraZeneca, Novo Nordisk, and Lundbeck etc. We also have a strong scientific knowledge about the underlying biology. But we are not that strong in taking the step from the lab to clinical studies and the market in relation to cell therapy due a lack of experience. In this case, CAMP will be an important vehicle for knowledge creation.”

In what way have you noticed an increased interest in companies that develop cell therapies?

”I have noticed an increased interest from authorities in Europe and Sweden about the need to increase knowledge about cell therapy. For example, Idogen received 2.9 MEUR from the EU last spring and CAMP is another example. I have also noticed an increased interest during my discussions with large pharma companies. It seems like most of them are building their strategies in this field. Some of them have advanced plans  while others are in the starting blocks, but all of them are interested and are following developments carefully. The CHMP decision about Cx601 is an important milestone for cell therapy and evidence of the possibilities.”

In order for these therapies to become a reality for patients, what are the challenges we need to overcome?

“Cell therapies are expensive and complex from a manufacturing point of view. Hence, the first treatments will address diseases with great medical need that are also expensive for society. Eventually manufacturing processes will need to become more effective and we are seing several initiatives within this area.”

What’s next for Idogen?

“We are currently working to optimize and transfer our cell therapy process from the lab bench to clinical scale. We will produce our cell therapy for the upcoming clinical studies in our own facility here in Medicon Village in Lund. We are currently establishing the quality systems and getting the equipment on-site.”

Photo of Lars Hedbys: Annette Säfholm