Goal to accelerate development, QC testing and manufacturing of Orgenesis’ cell and gene therapy platform
New assays being developed to potentially enhance the potency of cell and gene therapies for use within POCare platform
Plan to develop companion diagnostics to enhance targeting of cell and gene therapies
GERMANTOWN, Md., Aug. 23, 2021 (GLOBE NEWSWIRE) — Orgenesis Inc. (NASDAQ:ORGS) (“Orgenesis” or the “Company”), a global biotech company working to unlock the full potential of cell and gene therapies, has entered into a collaboration agreement (“Agreement”) with Savicell Diagnostics Ltd. (“Savicell”) to deploy Savicell’s patented ImmunoBiopsy™ immunometabolism platform with a goal of: (i) developing and validating diagnostic kits for enhanced quality control (QC) and monitoring purposes to be used by Orgenesis in manufacturing and processing of its cell and gene therapies; (ii) developing new assays to enhance the potency of cell and gene therapies for use within its point-of-care (POCare) platform; and (iii) developing companion diagnostics for potential enhanced patient targeting of cell and gene therapies.
Under the Agreement, Orgenesis will receive worldwide, exclusive rights and license to use and sell the kits produced by Savicell, which will include Orgenesis’ point of care network of hospitals, clinics and institutions for QC and monitoring of manufacturing and processing of autologous immune cells and autologous immune cells manipulated by cell and gene therapies.
Orgenesis intends to leverage this technology to measure the efficacy of various cell and gene therapies, as well as adaptations to enhance the potency of targeted therapies through selection and propagation of the highly potent cells during the manufacturing process. The initial QC kit will be utilized for cell therapy treatments targeting lung cancer, however the parties plan to expand the platform to include additional cancer types and other diseases.
One of the most important recent discoveries is that immune system cells alter their energy generation in order to obtain an effector function. Specifically, T cells change their pathways to create metabolic energy (ATP molecules) to enable them to potentially kill cancer. T cells, as a pre-step to their activation state, shift pathways to create metabolic energy, moving from the oxidative phosphorylation cycle into a glycolysis cycle. This shift into the glycolysis cycle enables faster production of energy for immediate utilization than in other cycles.
Vered Caplan, CEO of Orgenesis, stated, “Savicell’s ImmunoBiopsy platform has shown promise in early detection of cancer. We look forward to leveraging this technology in a number of key areas within our POCare platform. Among these applications, we believe this platform could be a powerful add on to our therapies for ensuring the highest level of quality control during cell production, as well as measuring the efficacy of various approaches and enhancing manufacturing strategies in advance of clinical trials. Unlike traditional pharmaceuticals, which can often be easily manufactured in bulk with high levels of consistency, the cell and gene therapy industry has faced major challenges maximizing the potency of autologous cell lines. We believe this technology holds enormous potential, not only for Orgenesis, but across the industry, in terms of maximizing the potency and ensuring consistency within the manufacturing process. We also look forward to developing companion diagnostics to identify those patients most likely to respond to appropriate therapies, which has been a major focus of FDA and payors.”
Giora Davidovits, CEO of Savicell, stated, “We are excited to partner with Orgenesis to adapt our ImmunoBiopsy platform for ensuring quality control, as well as measuring the potential efficacy of various therapeutic and manufacturing approaches to cell and gene therapies. Specifically, our method uniquely detects the metabolic change that occurs in the T cells metabolic pathways. The initial immune response to disease is intricate, deploying different metabolic pathways and subtypes of cells. The detection method is based on in-vitro recognition between T cells and disease-specific protein particles (synthetic peptides). In early disease detection, such as cancer, T cells are exposed to disease specific protein particles. In the lab, these T cells from blood samples are re-exposed to the cancer-specific protein particles (synthetic peptides that replicate those that are specific to the disease/condition). The resulting disease-specific shift to the glycolysis cycle within these cells is then measured and profiled. The differential metabolic responses of the immune system provide unique capability for early detection and are ideally suited to support enhanced manufacturing, maximizing potential potency, and companion diagnostics to support Orgenesis’ breakthrough POCare platform.”
