Orgenesis enters second phase of collaboration with Hospital Infantil Universitario Niño Jesús in Madrid with exclusive license to commercialize Celyvir solid tumor therapy

Orgenesis enters second phase of collaboration with Hospital Infantil Universitario Niño Jesús in Madrid with exclusive license to commercialize Celyvir solid tumor therapy 

The collaboration is focused on advancing clinical development and commercialization of the oncolytic virus-based cell therapy

Germantown, MD, US, March 11, 2021 – Orgenesis Inc. (NASDAQ: ORGS) (“Orgenesis” or the “Company”), a global biotech company working to unlock the full potential of cell and gene therapies, today announces that it has entered the planned second phase of a collaboration with Hospital Infantil Universitario Niño Jesús in Madrid, Spain. The collaboration is focused on an exclusive license agreement to further develop and commercialize the hospital’s proprietary Celyvir therapy for the treatment of solid tumors. 

The agreement follows an initial collaboration between FIB Hospital Infantil Universitario Niño Jesús and Orgenesis to establish a point-of-care center leveraging the Orgenesis POCare Platform, announced in May 2020. The POCare Platform has been designed by Orgenesis to enable hospitals and healthcare facilities globally to develop, optimize and manufacture cell and gene therapies throughout a POC Network of global healthcare facilities. 

“The Phase 1 trial data from children and adults with solid tumors indicates that Celyvir has a favorable safety profile and promotes disease stabilization,” said Dr. Manuel Ramírez MD, PhD, Head of the Pediatric Advanced Therapies Unit at the Hospital. “We have partnered with Orgenesis to rapidly develop Celyvir to its full potential. Both of our teams are dedicated to bringing groundbreaking cell and gene therapies, potentially starting with Celyvir, to patients worldwide through the Orgenesis POCare Network.”

The Celyvir therapy takes a new approach to the treatment of solid metastatic tumors. An oncolytic virotherapy is administered using autologous Mesenchymal Stem Cells (MSCs) obtained from bone marrow to improve the oncolytic virus potency. Oncolytic viruses are genetically modified viruses that induce targeted cancer-killing mechanisms. Traditionally, the intravenous administration of an unshielded oncolytic virus elicits an antiviral response. This leads to virus clearance without the desired oncolytic action. The bone marrow derived Celyvir therapy shields the virus using MSCs with reduced capacity to inhibit viral replication and viral load. These proprietary MSCs carry an oncolytic adenovirus (ICOVIR-5) that is designed to enhance oncolytic virus potency, to boost the acquired immune response and intensify the overall anti-tumor effect. This program represents a novel approach for the treatment of solid metastatic tumors, either as a monotherapy or in a combination with additional immunotherapies.

“Orgenesis has seen the potential of the Celyvir therapy to transform the treatment of solid metastatic tumors. This offers patients a lower toxicity profile and simpler treatment protocol. Aiding hospitals such as the Hospital Infantil Universitario Niño Jesús with developing these kind of therapies themselves is the exact reason why Orgenesis developed its POCare Platform,” said Vered Caplan, CEO of Orgenesis. “Now that the POCare Platform has demonstrated direct value to the Hospital Infantil Universitario Niño Jesús, we have decided to enter the second phase of the collaboration, and carry forward a long-term commitment to commercializing other promising immune-oncology therapies developed by the hospital.”

About Hospital Infantil Universitario Niño Jesús

Niño Jesús University Children's Hospital, birthplace of pediatrics in Spain, has been a national benchmark in pediatric healthcare since it was founded in 1877. It is leading the field of ATMPs for childhood and adolescent diseases in Spain, including cancer, transplantation, neuropediatrics and orthopedics, through an ambitious program of research, development, and manufacturing. It has the only authorized GMP facility for both gene and cell therapies in a medical center in Spain. 

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. Learn more about the work Orgenesis is doing 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, 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 sufficiency of working capital to realize our business plans, the development of our POCare strategy, our transdifferentiation technology as therapeutic treatment for diabetes which could, if successful, be a cure for Type 1 Diabetes, the technology behind our in-licensed ATMPs not functioning as expected, 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, 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