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., May 13, 2020 (GLOBE NEWSWIRE) -- 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.

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, the risk that the acquisition of Tamir’s assets will not be successfully integrated with our technologies or that the potential benefits of the acquisition will not be realized, our ability to further develop ranpirnase following the acquisition, our reliance on, and our ability to grow, our point-of-care cell therapy platform, our ability to effectively use the net proceeds from the sale of Masthercell, our ability to achieve and maintain overall profitability, the development of our POCare strategy, the sufficiency of working capital to realize our business plans, the development of our transdifferentiation technology as therapeutic treatment for diabetes which could, if successful, be a cure for Type 1 Diabetes; our technology not functioning as expected; our ability to retain key employees; our ability to satisfy the rigorous regulatory requirements for new procedures; 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 2019, 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.

Contact for Orgenesis:
David Waldman
Crescendo Communications, LLC
Tel: 212-671-1021
ORGS@crescendo-ir.com

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Source: Orgenesis Inc.