GERMANTOWN, MD – June 22, 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), today announces it has entered into a preliminary, non-binding term sheet with Leidos (“Leidos”) (NYSE: LDOS), a FORTUNE® 500 science and technology leader, to develop, and potentially obtain FDA marketing approval of Orgenesis’ Ranpirnase for the systemic treatment of patients suffering with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19.
Orgenesis recently acquired the assets of Tamir Biotechnology, Inc., including Ranpirnase, a broad spectrum anti-viral agent. Ranpirnase catalyzes the degradation of RNA, and mediates several essential biological activities, including the regulation of cell proliferation, maturation, differentiation, and cell death. Therefore, it is a potential candidate for the development of therapeutics for life-threatening diseases, including viral and autoimmune diseases, that require anti-proliferative and pro-apoptotic properties. Over 1,000 patients have been dosed with Ranpirnase in previous cancer/mesothelioma clinical trials. Ranpirnase has already demonstrated a strong safety and tolerability profile. Ranpirnase has also demonstrated preclinical antiviral activity in serious viral diseases, such as cytomegalovirus (CMV), influenza, HIV, Ebola, and SARS. This is based on its unique mechanism of action, which was shown to eradicate the virus and modulate the immune system in a series of in vitro studies.
Leidos conducted in vitro studies of Ranpirnase at the University of Tennessee Health Sciences Center Regional Biocontainment Laboratory (UTHSC RBL) and George Mason University National Center for Biodefense and Infectious Diseases (GMU NCBID) against the SARS CoV-2 virus. The in vitro studies demonstrated that Ranpirnase was significantly effective in killing the SARS CoV-2 virus – with an eight-fold average decrease in the number of plaque forming units when cultures with Ranpirnase were compared to the controls treated with a placebo. Based on these initial pre-clinical results, a pre-IND meeting request to fast track Ranpirnase for the treatment of SARS-COV-2 has been submitted by Leidos to the FDA.
Vered Caplan, CEO of Orgenesis, stated, “Based on the pre-clinical data, we are encouraged by the potential for Ranpirnase as an effective anti-viral therapy for SARS-COV-2. We believe this platform could address a significant need in the market and we look forward to leveraging Leidos’ expertise in development and clinical trial oversight, as well as relationships with government agencies, to possibly accelerate the development of Ranpirnase and its use as a potential treatment of patients with SARS-COV-2.”
Elizabeth Porter, Leidos Health Group president, said, “We are excited to team with Orgenesis for the development of Ranpirnase. We believe that this treatment has the potential to transform our understanding of SARS-COV-2 and provide new ways to fight this global pandemic. We look forward to collaborating with Orgenesis through each stage of the drug’s development.”
Leidos is a Fortune 500® information technology, engineering, and science solutions and services leader working to solve the world’s toughest challenges in the defense, intelligence, homeland security, civil, and health markets. The company’s 37,000 employees support vital missions for government and commercial customers. Headquartered in Reston, Va., Leidos reported annual revenues of approximately $11.09 billion for the fiscal year ended January 3, 2020. For more information, visit www.leidos.com.
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:
Crescendo Communications, LLC
Contacts for Leidos: