Nordic Life Science 1
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.” n 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. 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.” 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. 40