Orgenesis Announces Collaboration with Hospital Infantil Universitario Niño Jesús, Madrid, to Establish Point of Care Center

Collaboration project focused on clinical development and validation of Orgenesis’ immune-oncology cell therapies

GERMANTOWN, Md., May 22, 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 announced a research and development collaboration with Hospital Infantil Universitario Niño Jesús, Madrid, Spain, through its Biomedical Research Foundation, FIB, to establish a point-of-care center leveraging Orgenesis’ cell and gene therapy focused POCare Platform.

Under the collaboration agreement, FIB Hospital Infantil Universitario Niño Jesús will utilize Orgenesis’ CGT Biotech Platform to develop, optimize and manufacture cell and gene therapies. Orgenesis’ POCare Technologies enable hospitals to develop and supply cell and gene therapies, including Orgenesis’ proprietary POCare Therapies, by implementing Orgenesis’ proprietary know-how combined with automated, closed technology to process select cell therapies at each point-of-care site for the treatment of patients.

The first collaboration under the agreement between FIB Hospital Infantil Universitario Niño Jesús and Orgenesis involves the clinical development and validation of T-cell and dendritic cell-based therapies. Orgenesis’ CGT Biotech Platform, which combines processing and therapeutic technologies, is designed to allow for the efficient production of high quality, affordable cell and gene-based products. Upon successful completion of the first collaboration, Orgenesis and FIB Hospital Infantil Universitario Niño Jesús then plan to pursue the development of the Hospital’s oncolytic based cell therapy technology, Celyvir. This proprietary program represents a new strategy for the treatment of solid metastatic tumors based on oncolytic virotherapy administered by mesenchymal cells obtained from bone marrow.

Vered Caplan, CEO of Orgenesis, stated, “Hospital Infantil Universitario Niño Jesús will be an amazing addition to our POCare Network. We believe that our POCare Technologies will enable the hospital to advance this new therapy for the treatment of solid metastatic tumors based on oncolytic virotherapy. Our CGT Biotech Platform enables hospitals to accelerate the clinical development of life-saving therapies and potentially bring them to market in a more time and cost-effective manner. Furthermore, we expect that this collaboration will allow us to further develop and validate our POCare Therapies, including immune-oncology therapies.”

Dr. Manuel Ramírez MD, PhD, Head of the Pediatric Advanced Therapies Unit at Hospital Infantil Universitario Niño Jesús in Madrid, commented, “We look forward to collaborating with Orgenesis in order to develop our oncolytic based cell therapy. By utilizing Orgenesis’ CGT Biotech Platform, we seek to reduce the cost of bringing our technology to market, enabling others to use it in their patients, assuring high quality standards by integrating Orgenesis’ proprietary POCare Technologies.”

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.

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.

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.

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

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Source: Orgenesis Inc.