Orgenesis and Kurve Therapeutics announce pre-clinical study results for a cell-based oncolytic virus bearing product demonstrating over 50 percent reduction in a murine glioblastoma model

Cembines mesenchymal stem-cell-based product, with Kurve's intranasal drug delivery technology

Germantown, Maryland December 20, 2022 – Orgenesis Inc. (NASDAQ: ORGS) (“Orgenesis” or the “Company”), a global biotech company working to unlock the full potential of cell and gene therapies, and Kurve Therapeutics, a next-generation medtech and drug formulation company, today announced positive preclinical study results for intranasal administration of a cell-based oncolytic virus bearing product. The results demonstrated over 50 percent tumor reduction in a murine glioblastoma model.

The study was conducted by an independent pre-clinical research organization. In the study, the cell-based product was successfully delivered into the brain of mice via intranasal administration utilizing Kurve Therapeutics’ patented Controlled Particle Dispersion(R) technology as a novel approach to bypass the blood-brain barrier. Historically, the blood-brain barrier has been a primary roadblock in delivering therapies, especially for larger molecules and cellular therapies, directly to the brain.

Orgenesis, through its newly formed POCare services subsidiary, provides clinical grade manufacturing of the product to one of its customers, a premier cell therapy development company. The product has been administered to patients intravenously in collaboration with Hospital Infantil Universitario Niño Jesús in Madrid, Spain. The production is performed at the hospital utilizing the Orgenesis Mobile Processing Units and Lab (OMPUL) to supply clinical grade batches.

Glioblastoma Multiforme (GBM) is a highly aggressive cancer with an estimated five-year survival rate of 5 percent. The global glioblastoma multiforme treatment market size was valued at USD 2.14 billion in 2020 and is expected to increase at a compound annual growth rate of 8.8 percent from 2021 to 2028.

For glioblastoma patients, currently only a few treatment options exist. These current treatment options frequently present safety concerns, limit re-administration options, and carry a significant treatment burden. One of the reasons for the lack of effective treatments is due to suboptimal penetration of the blood-brain barrier for potential drug candidates into the central nervous system. This results in both poor distribution and efficacy.

“This is encouraging initial pre-clinical data, which demonstrates the potential of cell-based products combined with Kurve’s Controlled Particle Dispersion(R) technology to improve the administration of CNS-related treatments,” said Vered Caplan, CEO of Orgenesis. “Orgenesis, through its newly formed POCare services subsidiary, has commenced clinical grade production, in collaboration with Hospital Infantil Universitario Niño Jesús in Madrid for the supply of clinical grade batches of the cell-based product intended for intravenous administration. The nasal delivery of the cell-based product has only been tested in animal models thus far. Changing the administration route of a cell-based therapy, as with any drug product, requires rigorous testing and is considered a different therapy requiring a set of pre-clinical and clinical testing according to applicable regulatory guidelines. We appreciate the tremendous support of Hospital Infantil Universitario Niño Jesús in Madrid. We also look forward to expanding our collaboration with Kurve Therapeutics.”

Marc Giroux, CEO, Kurve Therapeutics said, “By delivering stem cells to the brain through the blood-brain barrier, a significantly broader array of treatments could potentially be non-invasively administered. This could open a host of opportunities to treat a multitude of central nervous system (CNS)-related disorders. Over 100 CNS-related clinical trials with stem cells are ongoing or planned to start near term. Our partnership with Orgenesis and the combination of the technologies has delivered very exciting recent pre-clinical results, which could expand the possibilities for more effective stem-cell-based therapies if future clinical trials are successful.”