Immunotherapy with the US in sight

Evelina Vågesjö’s research in immunophysiology at Uppsala University led her to found Ilya Pharma. The company is now developing the next generation of immunotherapy to heal wounds in both the skin and the gastrointestinal tract.

IT ALL STARTED when Evelina Vågesjö, Mia Phillipson, and Stefan Roos collaborated in an interdisciplinary research project and found new functions in immune cells that could be developed to affect their behavior. The trio chose to commercialize their innovation, and the step from research to development has gone fast.

In short, Ilya Pharma’s solution is about letting lactic acid bacteria produce the human therapeutic protein that heals wounds much faster. Through clinical trials and systematic experiments in animals, successful results have been achieved. Now a first product is being developed for the treatment of severe skin wounds.

– One area of application will be for diabetic patients with chronic wounds on their feet or legs. It is a common problem, but difficult to address. It can also be used for the treatment of wounds during surgery, especially in diabetics because they suffer an extra high risk of serious wound complications, says Evelina Vågesjö.

She has always had great faith in her innovation. Ilya Pharma has just received its first patents approved in the EU and the USA. The first patent application was filed as early as 2014.

– We have five other patents in other markets, but approvals in the EU and the US were a real milestone for us. Now we can continue to build a broader portfolio while protecting our upcoming strategic projects.

What has the time in Uppsala looked like from a development perspective?

– We have used all parts of the innovation system, which has been particularly important for the patent process. I was involved in several other projects as a researcher, but it was very scientific. I wanted to work with something that could benefit people and then patent protection is necessary. Through UU Innovation, she received advice and help with applications and strategy. One important piece of advice was to build a platform to show that the technology works with different types of bacterial strains. Through a grant from a fund in the Swedish bank Handelsbanken, the company was able to pay for the first patent application. Evelina herself has participated in Uppsala Innovation Centre’s training program for researchers who want to commercialize their research results.

– When we received a good response to the first patent application, we set up the company. Then we received 30 million SEK in EU grants from Horizon 2020, now known as the EIC Accelerator. That allowed us to work really fast, and we went from animal experiments to clinical trials in only sixteen months. The large contributions have also helped us to raise additional venture capital, as well as to recruit sharp people to the company. Today we have a team working from six different countries.

What about the future?

Evelina Vågesjö sees a big boom in cell and gene therapy.

– 90 percent of all companies in this field have been started after 2016, so it is a megatrend in the industry. In Europe, over 300 private investment rounds have been conducted and many of these innovations are now entering the clinical phase. Cell and gene therapy are changing the pharmaceutical industry in the same way biological drugs did 15 years ago. In five years, so-called microbiome drugs will also be common in clinical trials. It is very exciting.

Why are the big pharmaceutical companies not present in this market?

– Out of the 20 largest big pharma companies, only one has an in-house program for cell and gene therapy products. The innovations come from small and medium-sized companies that are often formed around a specific product or technology. It is no longer uncommon for a company – especially not within cell and gene therapy – to take a drug candidate all the way to market approval. Half of all new approvals from the FDA and EMA are granted to a company that gets its first product approval. I think we are addressing the medical needs that the classic drugs have failed to address.

Are acquisitions an option for the larger players?

– It all depends on which therapy fields and skills you are looking for. The difference is that it is not always possible to build a generic process for this type of drug – the development must come from science, while both regulatory and investment assessment are more on a case-by-case basis. Since cell and gene therapy are more disruptive, it is often difficult to compare directly with traditional drug candidates.

What is your time horizon for the future?

– We plan to submit our first product for wound treatment for market approval in 2024, which is super-fast compared to many other projects. But it is still a long time and some risks remain until then. We will start with the US and the FDA since we see that Europe is a more fragmented market for our type of product. EMA has done a great job of harmonizing, but there is still some way to go – in some countries you can suddenly be placed in the agricultural category, and the processing can just as easily take two months as two years. In the United States, it is one process, one authority, and one market.