IPBLN Patent to Treat Crohn’s Disease
A patent awarded to the research team headed by Mario Delgado at the López Neyra Parasitology and Biomedicine Institute (IPBLN) has been used to create Alofisel, a pioneering drug for the treatment of one of the most serious complications of Crohn’s disease. The IPBLN is run by the Spanish Council for Scientific Research (CSIC) and is based in the Granada Health Science Technological Park (PTS).
Alofisel has been shown to be an effective treatment for anal fistulas, which until now could only be treated surgically in many cases. Mario Delgado described the drug development process at an event held at the PTS Andalusian Public Foundation headquarters, where he was joined by Foundation trustee Juan José Martín Arcos.
The drug, developed by Tigenix, a company recently acquired by Japanese pharmaceutical company Takeda, has received marketing authorisation from the European Medicines Agency. It was also recently awarded the Prix Galien Italy 2018, considered the pharmaceutical industry's equivalent of the Nobel Prize, in the Advanced Therapies category.
Alofisel is the first allogeneic stem cell treatment to be approved for the European market. The treatment is derived from adipose stem cells sourced from donors who are not related to the future patients.
According to Mario Delgado, “up until now, cell therapy has generally been designed to use cells from the patient him or herself, which is known as syngeneic treatment. With this new treatment approach, stem cells become a drug like any other. In other words, they can be produced by pharmaceutical companies in large quantities and distributed around the world. Also, in this case, because the cells are derived from adipose tissue or fat, they can be collected from numerous donors in the Western world through liposuction procedures. This is a major breakthrough in cell therapy. When the treatment was approved in Europe, some experts described it as the discovery of the decade for these Crohn’s patients.”
Mr Delgado went on to say that “by definition, a patent is a means of protecting a novel research finding. It is the legal right granted to an inventor or researcher that allows them to use their invention or license or sell it to third parties.”
In this case, CSIC licensed Mr Delgado's invention to Tigenix/Takeda, enabling the company to go on to develop Alofisel. Mr Delgado's team of researchers discovered that certain populations of stem cells in adipose tissue could regulate the immune system, and that this regulatory effect could be used to prevent, treat or improve autoimmune diseases, inflammatory disorders and immune-mediated diseases, including the rejection of transplanted tissues and organs.
According to Mario Delgado, “we found that these stem cells didn't just have a regenerative effect, which was what they were being used for at that time, but they were also able to regulate inflammatory and autoimmune responses. We did all the pre-clinical development, which was the first new development in the research. The second new development, which is what changed the way these cells are used, was being able to use them as an allogeneic therapy, where the donor is not related to the patient. The combination of these two developments was what was patented in the first instance.”