Orgenesis announces collaboration agreement with Savicell to license and deploy its ImmunoBiopsy(TM) platform

Orgenesis announces collaboration agreement with Savicell to license and deploy its ImmunoBiopsy(TM) platform

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, Maryland, US, August 24, 2021, - 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(TM) 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 the 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 a 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.”

About Savicell
Savicell’s Well-Shield(TM) is a first-in-class liquid ImmunoBiopsy(TM) platform that non-invasively measures the metabolic state of the immune system and acts as a diagnostic link to early disease states. The field of “immunometabolism” is rapidly emerging. It is driven by the discovery that the normal metabolic state of the immune system is linked to its ability to combat infectious diseases and cancer. Savicell is at the forefront currently focused on developing diagnostics in this new space.

Initially, Savicell is focused on the multibillion-dollar cancer diagnosis market. If cancer is found at an early stage when it is small and before it has spread, people have a better chance of survival. In contrast to existing liquid biopsy technologies that evaluate secretions of cancer cells, Well-Shield’s platform derives data directly from the immune system, which Savicell believes will provide earlier detection than that available from existing approaches.

Savicell demonstrated a compelling cross-validated clinical study in lung cancer that was published in Cancer Immunology and Immunotherapy. The clinical study yielded 91 percent sensitivity and 80 percent specificity. Importantly, Savicell achieved 90 percent + sensitivity in detecting stage 1 cancer. Additional information about the company is available at: http://www.savicell.com/.

About Orgenesis
Orgenesis is a global biotech company working to unlock the full potential of cell and gene therapies (CGTs) in an affordable and accessible format at the point of care. The Orgenesis POCare Platform is comprised of three enabling components: a pipeline of licensed POCare Therapeutics that are processed and produced in closed, automated POCare Technology systems across a collaborative POCare Network. Orgenesis identifies promising new therapies and leverages its POCare Platform to provide a rapid, globally harmonized pathway for these therapies to reach and treat large numbers of patients at lowered costs through efficient, scalable, and decentralized production. The POCare Network brings together patients, doctors, industry partners, research institutes and hospitals worldwide to achieve harmonized, regulated clinical development and production of the therapies. www.orgenesis.com

Notice Regarding Forward-Looking Statements
This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended. These forward-looking statements involve substantial uncertainties and risks and are based upon our current expectations, estimates and projections and reflect our beliefs and assumptions based upon information available to us at the date of this release. We caution readers that forward-looking statements are predictions based on our current expectations about future events. These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions that are difficult to predict. Our actual results, performance or achievements could differ materially from those expressed or implied by the forward-looking statements as a result of a number of factors, including, but not limited to, our reliance on, and our ability to grow, our point-of-care cell therapy platform, our ability to achieve and maintain overall profitability, our ability to manage our research and development programs that are based on novel technologies, our ability to control key elements relating to the development and commercialization of therapeutic product candidates with third parties, the timing of completion of clinical trials and studies, the availability of additional data, outcomes of clinical trials of our product candidates, the potential uses and benefits of our product candidates, our ability to manage potential disruptions as a result of the coronavirus outbreak, the sufficiency of working capital to realize our business plans, the development of our POCare strategy, our trans differentiation technology as therapeutic treatment for diabetes, the technology behind our in-licensed ATMPs not functioning as expected, our ability to further our CGT development projects, either directly or through our JV partner agreements, and to fulfill our obligations under such agreements, our license agreements with other institutions, our ability to retain key employees, our competitors developing better or cheaper alternatives to our products and the risks and uncertainties discussed under the heading "RISK FACTORS" in Item 1A of our Annual Report on Form 10-K for the fiscal year ended December 31, 2020, and in our other filings with the Securities and Exchange Commission. We undertake no obligation to revise or update any forward-looking statement for any reason.