Orgenesis announces cell-based vaccine platform targeting COVID-19 and other existing and emerging viral diseases

Initiating a novel program targeting the virus and virus infected cells, using whole cell-based vaccines

GERMANTOWN, MD, US, May 13, 2020 - Orgenesis Inc. (NASDAQ: ORGS) (“Orgenesis” or the “Company”), a pioneering global biotech company committed to accelerating commercialization and transforming the delivery of cell and gene therapies (CGTs) while lowering costs, today announces the launch of its new cell-based vaccine platform targeting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, as well as other viral diseases such as Zika, West Nile Virus, Yellow Fever, Dengue Fever, MERS, HCV and Cytomegalovirus infection (CMV).

The Company has been working aggressively the last few months to repurpose its cell-based vaccine platform targeting solid tumors for use against viral diseases.  The cell-based vaccine platform utilizes irradiated permissive cells (human or non-human, infected with a high titer virus or transfected with viral antigens), which then activate endogenous dendritic cells.  In turn, these cells activate CD4+T cells and cytotoxic CD8+ T cells. CD4+ cells activate humoral immune response via B cells, which generate neutralizing antibodies, while CD8+ cell mount cytotoxic immune response against virus-infected cells.

This cellular vaccine platform represents the culmination of extensive research and development already undertaken that leverages the Company’ development and manufacturing expertise within the cell and gene therapy sector.  Orgenesis believes this new vaccine platform offers a unique approach to cell vaccination that holds promise for an affordable and reproducible vaccine for both COVID-19 and other viral diseases.  The Company is moving forward with planned animal testing for its cell-based vaccine platform in COVID-19 and looks forward to providing a more detailed timeline of activities including plans for initial human testing, assuming clearance from the FDA and/or other non-US regulatory bodies to do so.  Orgenesis has not yet submitted any such plans or data to the FDA or any other regulatory body.

About Orgenesis

Orgenesis is a pioneering global biotech company which is unlocking the full potential of personalized therapies and closed processing systems through its Cell & Gene Therapy Biotech Platform, with the ultimate aim of providing life changing treatments at the Point of Care to large numbers of patients at low cost. The Platform consists of: (a) POCare Therapeutics, a pipeline of licensed cell and gene therapies (CGTs), and proprietary scientific knowhow; (b) POCare Technologies, a suite of proprietary and in-licensed technologies which are engineered to create customized processing systems for affordable point of care therapies; and (c) POCare Network, a collaborative, international ecosystem of leading research institutes and hospitals committed to clinical development and supply of CGTs at the point of care. By combining science, technologies and a collaborative network, Orgenesis is able to identify the most promising new therapies and provide a pathway for them to reach patients more quickly, more efficiently and at scale, thereby unlocking the power of cell and gene therapy for all. Additional information is available at: www.orgenesis.com.