Exclusive License Agreement Secured With Erganeo for EVerGel, EVerZom's Breakthrough Treatment for Fistulas & Fibrosis of the Digestive Tract

EVerZom, a CNRS/Université Paris Cité spin-off specializing in exosomes, has announced the signature of a second exclusive license agreement with Erganeo for the development of EVerGel , a drug candidate tailored for the healing of digestive tissues. EVerGel is the first therapeutic program developed by EVerZom in collaboration with Professor Gabriel Rahmi, hepato-gastroenterologist and endoscopist at the Georges Pompidou European Hospital in Paris, and Amanda Silva Brun, winner of the 2021 CNRS innovation medal and director of research at the CNRS Matter and Complex Systems Laboratory at Université Paris Cité.

EVerZom initially focused its efforts on the development of an innovative platform, protected by several patents, covering the entire value chain: cell selection, production of high-yield exosomes, their modification and formulation.

With the invaluable support of Erganeo, which oversaw the final developments required for these new production methods, the intellectual property was transferred to EVerZom in 2019 and a second exclusive license agreement was signed today. Leveraging these innovative technologies, EVerZom’s goal is to demonstrate the therapeutic potential of its exosome platform to address a variety of diseases with significant unmet medical needs. The credibility of this platform has been further strengthened by validation from both national and European innovation ecosystems, in particular through the i-lab innovation contest and the EIC Accelerator program.

EVerZom’s first clinical application focuses on digestive tissue regeneration using naive exosomes derived from stem cells encapsulated in a gel called EVerGel. EVerGel’s lead indication is the healing of complex ano-perianal fistulas induced by Crohn’s disease. In addition, EVerZom has identified several other indications in its pipeline, all of which have demonstrated proof of concept in vivo. These include stenosis, the healing of surgical anastomoses following tumor resection of the digestive tract, including the investigation of post-operative adhesions (esophageal, rectal and colon cancers). EVerGel can be delivered endoscopically or injected directly into the fistula.

“Preclinical studies have demonstrated the efficacy of EVerGel in 8 animal models, including three porcine models. The results are very encouraging, with over 85% complete closure of fistulas treated by endoscopic injection, compared to only 12% in the control group. These results are particularly promising for patients suffering from complex digestive fistulas or stenosis, who require innovative treatments to improve their quality of life. I am convinced that EVerGel will meet this need,” said Prof Gabriel Rahmi, Clinical Hepato-Gastroenterologist at the HEGP and co-inventor of EVerGel .

In February 2024, EVerZom participated in the 19th Congress of the European Crohn’s and Colitis Organization (ECCO) in Stockholm to share with clinicians and innovation experts the latest preclinical data on its exosomes-based therapies, in particular EVerGel, and their clinical prospects.

Exosomes are one of the main communication pathways between the body’s cells, via lipids, proteins, and nucleic acids, among others. The size of these biological nanoparticles is about 150 nm, and these particles are found everywhere in our body and fluids (blood, urine, saliva) by 10 times more in the body compared to cells. Acting as FedEx for cells, exosomes have amazing properties: they have a low immunogenicity (i.e. they don’t trigger immune system reactions) and have a strong natural capacity for cell uptake enabling strong targeting. The high interest in exosomes research and applications is leading to an explosion in the number of publications, with more than 8500 in 2022, and an increase in the number of clinical trials in which their safety, and first signals of efficacy have been demonstrated. Last but not least, over the last 5 years, exosomes have been the focus of a sharp increase in partnerships between Big Pharma and innovative biotechs.

Leveraging its innovation platform, EVerZom’s ambition is to develop its pipeline of proprietary biotherapies in regenerative medicine, while building partnerships in several other indications.

EVerGel combines exosomes derived from stem cells with a heat-sensitive gel, enabling targeted and precise delivery. Preclinical studies have demonstrated promising efficacy in 8 animal models, paving the way for regulatory preclinical entry scheduled for the end of 2024 and entry into clinical trials at the end of 2026.

Crohn’s disease is a chronic inflammatory disease of the digestive tract that affects approximately 2 million people worldwide. More than 50% of these patients will develop ano-perianal fistulas during the course of their disease, and in more than one-third of patients, ano-perianal lesions will be at the origin of the diagnosis. The persistence of fistulas tracts is a marker of the severity of Crohn’s disease and has a significant negative impact on patients’ quality of life and functional prognosis. This complication requires complex, multidisciplinary treatment (surgery and biological drugs), the results of which are still unsatisfactory, with only 40% of patients achieving complete healing of the complex fistula.

EVerGel is expected to enter regulatory preclinical trials by the end of 2024, with first-in-man administration within 2 years.

EVerZom, a CNRS/Université Paris Cité spin-off dedicated to exosomes, was created in 2019 with the aim of becoming a leader in exosome biotherapies. To this end, the company has developed a proprietary platform that covers the entire technological value chain: cell sourcing, exosome generation, engineering, and formulation. Winner of numerous awards and programs, including the i-Lab program and the prestigious EIC Accelerator for its technological innovation platform, EVerZom is developing a pipeline of proprietary drug candidates in regenerative medicine, while leveraging on partnerships in many other indications.

Erganeo is a French technology transfer company specializing in disruptive innovations (DeepTech) with a high societal impact. We invest as early as possible to secure researchers’ new inventions, before they are transferred to industry or start-ups are created, in a wide range of scientific fields: Biotech (health, agrifood, environment, cosmetics), Infotech (telecoms, internet of things, big data, AI), Enertech (green energies, chemistry, materials), and so on. Our mission is to accelerate and simplify the links between research and industry, in the interests of societal progress. To do this, we fund and support the next generation of French researcher-entrepreneurs, helping them to achieve success and international recognition. As a member of the SATT network, Erganeo is laying the foundations for a desirable future in the Paris Region ecosystem, a breeding ground for innovation with 20,000 researchers in over 350 cutting-edge research laboratories. Since its creation, Erganeo has invested nearly €44m, helping to sign 120 licenses with companies of all sizes and to create 34 start-ups.