First collaboration project focused on developing and commercializing lentiviral manufacturing system

GERMANTOWN, Md., Jan. 10, 2020 (GLOBE NEWSWIRE) -- Orgenesis Inc. (NASDAQ: ORGS), a leading cell and gene therapy enabling company providing centralized CDMO manufacturing and development services, as well as localized point-of-care development and processing centers through its subsidiary Orgenesis Maryland, Inc., today announced the addition of the University of California, Davis (UC Davis) to its Point of Care (“POCare”) Network. Under the collaboration agreement, UC Davis Health will utilize Orgenesis’ POCare platform to develop, commercialize and supply cell and gene products and therapies. Orgenesis’ POCare Network enables hospitals to design and manage localized clean rooms, implementing Orgenesis’ proprietary automated, closed systems and know-how to process select cell therapies at each point-of-care site for the treatment of patients.

The first collaboration under the agreement involves scaling up and integrating UC Davis’ lentiviral vector process as part of the Orgenesis POCare platform for localized, development and processing of cell and gene therapies for treating patients. The UC Davis GMP facility has developed a small-intermediate scale, high quality vector process that has been successfully utilized to manufacture lentiviral vectors in several clinical trials, including manufacturing of CAR T cell therapies. Orgenesis’ POCare 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 collaboration, Orgenesis and UC Davis plan to pursue further commercialization of the technology and expand the processing and supply of their products under development at the UC Davis site. Lentivirus is a family of viruses that insert their DNA into the host cells' genome. Lentiviral vectors are increasingly utilized in cell and gene therapy as a method for inserting, modifying, or deleting specific genes within cells.

Vered Caplan, CEO of Orgenesis, stated, “We are delighted to add UC Davis to our POCare Network, which will allow us to collaborate with the university to develop and supply therapeutics within the point-of-care setting in general and specifically in our need for virus supply. Additionally, we look forward to leveraging our POCare platform to assist UC Davis in expanding their ability to address the worldwide shortages of lentiviral vectors. Their new system is designed to address the global need for a more efficient, large scale vector manufacturing processes in an efficient manner. We believe this partnership further validates the significant value proposition of our POCare platform.”

Adjunct Professor Gerhard Bauer, Director of the GMP Facility at UC Davis, commented, “We, at the UC Davis Health, in the Stem Cell Program and in the GMP Facility, are committed to bringing these novel cell and gene therapy based treatments to patients in need and making them affordable.”

Professor Jan A. Nolta, Director of the Stem Cell Program and the Gene Therapy Center at UC Davis Health, added, “We look forward to leveraging Orgenesis’ expertise to accelerate the development and commercialization of our lentiviral vector manufacturing system, which addresses a significant unmet need in the market for an efficient and scalable manufacturing process.”

About Orgenesis

Orgenesis is a biopharmaceutical company specializing in the development, manufacturing and processing of technologies and services in the cell and gene therapy industry. The Company operates through two platforms: (i) a point-of-care (“POCare”) cell therapy platform (“PT”) and (ii) a Contract Development and Manufacturing Organization (“CDMO”) platform conducted through its subsidiary, Masthercell Global. Through its PT business, the Company’s aim is to further the development of Advanced Therapy Medicinal Products (“ATMPs”) through collaborations and in-licensing with other pre-clinical and clinical-stage biopharmaceutical companies and research and healthcare institutes to bring such ATMPs to patients. The Company out-licenses these ATMPs through regional partners to whom it also provides regulatory, pre-clinical and training services to support their activity in order to reach patients in a point-of-care hospital setting. Through the Company’s CDMO platform, it is focused on providing contract manufacturing and development services for biopharmaceutical companies. Additional information is available at: www.orgenesis.com.

About UC Davis Stem Cell Program and Gene Therapy Center

UC Davis’ Stem Cell Program brings together physicians, research scientists, biomedical engineers and a range of other experts and collaborative partners at its Institute for Regenerative Cures, which is located on the university’s Sacramento campus. The $62 million facility, which was supported by the California Institute for Regenerative Medicine (CIRM), is the hub for collaborative, team-oriented science that is advancing breakthrough discoveries designed to bring stem cell therapies and cures to patients everywhere.

The UC Davis Gene Therapy Center brings together a uniquely comprehensive and established interdisciplinary network of experts and resources to lead the field of gene therapy through research, manufacturing, training and policy. The Gene Therapy Center offers expertise and state-of-the-art facilities and equipment including one of the largest university-based Good Manufacturing Practice (GMP) facilities and a Viral Vector Core.

About UC Davis

UC Davis is one of the top public universities in the United States. Since opening in 1908, it has been known for standout academics, sustainability and Aggie Pride as well as valuing the Northern California lifestyle. These themes are woven into its 100-plus-year history and its reputation for solving problems related to food, health, the environment and society. The university’s health system is based in Sacramento and provides the region's only academic health center. UC Davis Health is focused on discovering and sharing knowledge and providing the highest quality of care. It is a hub of innovation that encompasses UC Davis Medical Center, UC Davis School of Medicine, The Betty Irene Moore School of Nursing at UC Davis and UC Davis Medical Group.

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 success of our reorganized CDMO operations, the success of our partnership with Great Point Partners, 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 trans-differentiation 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 November 30, 2018, 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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