What began as a project for Evelina Vågesjö’s doctoral thesis grew into groundbreaking drug candidates and delivery methods, followed not long afterwards, by a clinical-stage biopharmaceutical company.
Fascinated by the workings of the human body, Evelina Vågesjö, born and raised in Småland, Sweden, began researching a way to help the body heal hard-to-heal wounds as a project for her doctoral thesis studies at Uppsala University. She had decided to major in Physiology because of her interest in the mechanics of the human body, and was able to study other fields as well.
“I got the chance to study Immunology and I was able to study in real time how bodily functions work,” she says. ”I was able to observe how immune cells regulate blood flow in wounded tissue.”
She developed, and continues to refine, genetically modified lactic acid bacteria that act as ”mini-bioreactors” at the treatment site to produce chemokines, human therapeutic proteins, directly to the injured site – nudging the local immune cells to reduce inflammation or assist with and accelerate the healing and regenerative processes. This provides a new and cost effective way to deliver biological drugs.
From a thesis to a company
Her findings led to the foundation of a company, Ilya Pharma, in 2016, co-founded with Mia Phillipson, Professor in Physiology at Uppsala University, and Stefan Roos, Associate Professor in Microbiology at the Swedish University of Agricultural Sciences.
”We had the scientific findings of chemokines and immune cells in injured and ischemic tissue at Uppsala University with gene therapy based approaches. Then we developed the technology platform where lactic acid bacteria express the chemokines (ILP-drug candidates) and when we tested them and they worked better than expected in animal models, we founded Ilya Pharma and transferred all data and intellectual property developed to the company.”
”I was able to transfer my work seamlessly from the university to my own company. The Swedish government is very supportive of businesses coming out of universities,” she adds.
The company’s treatments target the function of tissue-resident immune cells, and the mechanism of accelerated healing in skin wounds was published in PNAS in 2018.
During the foundation of Ilya, Evelina says that business-wise she learned a lot from Ingemar Kihlström, the current Chairman of the Board. ”He has helped me to consider what is best for the company during each stage of growth. I am very grateful that he has had, and continues to have, time for me and Ilya Pharma.”
Her former professor, co-founder and business partner, Mia Phillipson, has meant everything for the scientific parts of the company, Vågesjö adds. ”I thought that she had a fantastic approach to science ten years ago and it is just getting better and better. She is very brave and continues to amaze me and others.”
She and her co-founders have run the drug development operations from Ilya Pharma since then, with Vågesjö spurred on by a desire to see her work go beyond the lab.
“I wanted to understand if my scientific findings had practical applications. It’s fantastic if you can describe 20 different surface markers of an immune cell – but I want to know what they do.”
“I wanted to understand if my scientific findings had practical applications,” explains Vågesjö. “It’s fantastic if you can describe 20 different surface markers of an immune cell – but I want to know what they do. The projects [at Uppsala University] became applied science and I wanted to know if they had clinical applications. I hope I can learn enough to make a difference for patients.”
Not surprisingly, Vågesjö says the company’s peak so far was when they received the first approval to start the first clinical trial.
Running a company
Having managed her project from an initial idea to clinical proof of concept and scaling of the company, today, at age 34, Evelina Vågesjö, CEO of Ilya Pharma, has been recognized numerous times for her achievements. For example, she has been selected to the Springboard Enterprises’ Health Innovation Hub in the life sciences and she was one of the recipients of the MIT Innovations Under 35 award in 2019.
“Science and business administration really complement each other. My business studies also helped me see the need for practical applications of discoveries.”
Besides her PhD in Physiology, Vågesjö also has a BSc in management accounting and an MBA focused on finance and mergers and acquisitions, which she says came in handy as she got Ilya Pharma up and running. “Science and business administration really complement each other. My business studies also helped me see the need for practical applications of discoveries.”
One of the challenges of starting a business has been finding people best suited for different milestones, she says.
“I appreciate when I work with someone who has the right mindset. The skill has to be very specific to the field we are active in. Sometimes you have to work very hard to find an expert.”
“Ilya has been developing a new type of pharmaceutical drug candidates and we have to be disruptive on many different fronts – there is no normal right now for the framework we’re using. I appreciate when I work with someone who has the right mindset. The skill has to be very specific to the field we are active in. Sometimes you have to work very hard to find an expert. Everything needs to be aligned.”
As CEO, she describes her leadership as committed to the objectives. ”I also empower others in our team, and I challenge people to be their smartest.”
Like most scientists at pharmaceutical companies, Vågesjö has been monitoring the COVID-19 pandemic and efforts to stop it. She says she does not expect the disease spread to be under control within six months, but like most people, she is hopeful a vaccine will come along in the not-so-distant future.
“It’s important that the safety and efficacy (of any vaccine) are tested and people make informed decisions based on the efficacy level,” she said. “It’s important that it is well thought-out and that quality is maintained in the vaccine. Vaccines are fantastic when they work; the best case would be that a vaccine is available within a short time, so that COVID is not an issue in a few years.”
The best chance of success
Ilya Pharma is currently pursuing three projects with drug candidates from its own technology platform to proof of concept in clinical phase I and II. The potential drugs are classified as advanced therapy medical products (ATMPs) or gene therapies by the European Medicines Agency (EMA) and the US Federal Drug Administration (FDA). The company is targeting unmet clinical needs, including post-surgical wounds in special populations, problematic diabetic wounds, and indications in the gastrointestinal tract, such as inflammatory bowel disease, as well as damaged mucosa.
One of Vågesjö’s goals is to efficiently mesh the clinical development with corporate aspects, to provide the most efficient way for drugs to be tested.
“Each phase of development increases likelihood for approval,” she says. “We want to give the drug compound the best chance of success in clinical development.”
In early September, the United States Patent and Trademark Office (USPTO) issued a patent to Ilya that includes “broad claims that cover a plasmid capable of expressing CXCL12 in lactic acid bacteria the protein, transformed lactic acid bacterial strains comprising the plasmid and a number of products comprising the transformed bacteria.” The statement notes that the inventions covered are critical to the company’s programs for treating wounds in humans and animals.
“I’m very happy to now have a platform to also run a project to heal wounds in the gastrointestinal tract.”
The progression of a topical product for wound healing to the clinical phase freed up some time recently for Ilya to pursue its other project related to inflammatory bowel disease.
“We had interesting mechanistic data in this indication already before founding Ilya Pharma, but had to focus on one project first, and the topical administration was the shortest way to clinical proof of concept and the first priority,” says Vågesjö. “I’m very happy to now have a platform to also run a project to heal wounds in the gastrointestinal tract. We are really able to do this project justice. It’s been really fun. With a second project, you can do things smarter and faster based on what you learned.”
Cell and gene therapy on the rise
Vågesjö notes that there is a growth in cell and gene therapy and biotechnology therapeutics, and more projects are entering clinical phase, following investments into this field.
”This is the space where we see the most change. More companies are raising funds for this. Beginning this year, the FDA is expecting to approve more than 20 new drugs in the cell-and gene therapy sector per year, for several years,” she says.
Although the majority of Ilya’s financing does not come from the Nordic region – they get a lot of European Union funding – the Nordic countries are always well-prepared when it comes to research, says Vågesjö. “In Sweden, the number of spinoff companies from academia is growing.”
As for her own work, Vågesjö says she is passionate about finding the optimal financing and strategy for projects, giving drug candidates the best possible chance in clinical trials. She says that the favorite part of her job comes, “When I’ve been working on very complex projects and they come out right and we will have a new-to-the-world drug compound, and when we get confirmation of success after completing larger milestones.”
Within ten years, the objectives are that at least one of the ILP-drug candidates has been marketed and delivers clinical value to patients and society, and that its use limits the spread of antibiotic resistance, Vågesjö says.
The next steps
When she is not at Ilya Pharma, Vågesjö, who is married, enjoys exercising outdoors and spending time with old friends, “The ones who will tell you if you are wrong in a millisecond.”
Just as she has taken a different approach to researching potential treatments, Vågesjö says she would strive to take care in the message conveyed to upcoming researchers.
“Science matters every step of the way, throughout the whole journey. You have a responsibility to take care of all your scientific findings.”
“Science matters every step of the way, throughout the whole journey,” she says. “You have a responsibility to take care of all your scientific findings. Many people have said to those starting companies ‘That is a lot of work’, ’that will be difficult’, and that is mostly just jargon. I will never say that. I will help them find the next step to get better.”
Photographer: Jenny Öhman/Nordic Life Science. This interview was originally published in Nordic Life Science magazine, No 04 2020