Israel-based Savicell will use its immunometabolism platform, ImmunoBiopsy, to develop assays that will enhance the potency of cell and gene therapies for use within Orgenesis' point-of-care (POCare) cell therapy platform.
Additionally, Germantown, Maryland-based Orgenesis will use the platform to develop and validate diagnostic kits for enhanced quality control (QC) and monitoring purposes when it comes to the manufacturing and processing of its cell and gene therapies; as well as developing companion diagnostics to identify patients who will respond to those therapeutics.
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.
Challenges around ex-vivo expansion of TILs
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.
Moran Meiron, head of TILs program, Orgenesis, told BioPharma-Reporter about the advantages of the ImmunoBiopsy platform in this respect:
“Through our POCare Platform, Orgenesis is developing a robust pipeline of autologous cell therapies, including several cell-based immunotherapies.
“One of our leading cell-based immunotherapy candidates, MOTC, utilizes Tumor Infiltrating Lymphocytes (TILs), a type of immune cell that recognizes and kills cancer cells, to treat solid tumors.
“Using a proprietary closed, semi-automated and xeno-free process, the lymphocytes are isolated from the resected tumor tissue, then stimulated and expanded before being infused back to the patient.
“One concern associated with the ex-vivo expansion of TILs is the potential exhaustion of the lymphocytes during the production process. Thus, we partnered with Savicell to leverage their proprietary bio-assay for the detection of the metabolic state of T lymphocytes under the assertion that monitoring the cell’s metabolic state will allow us to better establish the anergy status of the cells. Ultimately, this technique should enable us to determine the optimal timing for the cell harvesting step, allowing it to occur prior to lymphocyte exhaustion and the consequent anergy.”
Vered Caplan, CEO of Orgenesis, believes this technology holds enormous potential, not only for it, 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,” she said.
Metabolic responses provide key
Giora Davidovits, CEO of Savicell, said its technology 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.”