Orgenesis signs MOU with University of California, Davis to develop a collaboration agreement to deploy cell and gene therapy Mobile Processing Units and Labs across California

Orgenesis signs MOU with University of California, Davis to develop a collaboration agreement to deploy cell and gene therapy Mobile Processing Units and Labs across California

Germantown, Maryland, US, March 15, 2023 – Orgenesis Inc. (NASDAQ: ORGS) (“Orgenesis” or the “Company”), a global biotech company working to unlock the full potential of cell and gene therapies (CGT) at the point of care, today announces the signing of a non-binding memorandum of understanding (MOU) with University of California, Davis (UC Davis).

The MOU was signed by Orgenesis POC CA Inc., a Delaware Corporation (“Orgenesis POC CA”) incorporated by Orgenesis’ POCare service subsidiary, Morgenesis LLC ("Morgenesis"), and The Regents of the University of California, on behalf of its Davis campus (“University”). The goal of the MOU is to progress towards a wider agreement pursuant to which the University and Orgenesis POC CA expect to rollout Morgenesis' proprietary Orgenesis Mobile Processing Units and Labs™ (“OMPULs™”) throughout universities within the State of California, US.

Both Orgenesis, through Orgenesis POC CA and the University, aim to rollout the OMPULs within the State of California in a staged approach. The first stage involves establishing and validating an OMPUL at UC Davis, anticipated to be within the first 12 months following execution of a definitive agreement between the parties. Thereafter, both parties will agree upon and develop a decentralized model of OMPUL placement in compliance with regulatory requirements, as well as commercialize and install OMPULs at other healthcare sites within the State of California. The intent is to enable the development and manufacture of cell and gene therapies from Orgenesis, its partners, and UC Davis’ partners. Orgenesis POC CA or its affiliates and the University may agree to develop and/or manufacture other therapies initiated from the University and/or third parties for point of care treatment of patients utilizing the OMPUL, subject to a further agreement(s). 

“The cell and gene therapy sector continues to expand and develop solutions for patients suffering from a range of conditions. However, despite the sector maturing, there is still yet to be drawn a clearly defined roadmap to enable patients to reach and benefit from these life-saving therapies. Orgenesis has designed its OMPULs to decentralize manufacturing and enable cell and gene therapies to be developed on the site of universities, hospitals and healthcare providers, with the goal of reducing the costs of developing these therapies. This is vital to make the widespread delivery of life-saving therapies to patients a reality. As a result, Orgenesis, through its subsidiary Morgenesis, is installing OMPULs in the US and internationally,” said Vered Caplan, CEO of Orgenesis. “It is anticipated that this partnership with UC Davis and the universities across California will provide decentralized development and manufacturing of CGTs across a major US healthcare state. This could result in the development of CGTs to patients across a range of conditions at a cost that can be supported by payers and the wider society as a whole.”

UC Davis originally signed a collaboration agreement to join Orgenesis’ Point of Care (“POCare”) Network on January 9, 2020. UC Davis Health has been utilizing Orgenesis’ POCare platform to develop, commercialize and supply cell and gene products and therapies. Orgenesis’ POCare Network enables hospitals to expand their capacity to supply cell therapies at the point-of-care site for the treatment of patients. The agreement involved the scaling up and integrating UC Davis’ lentiviral vector process as part of the Orgenesis POCare Service Platform for localized development and processing of cell and gene therapies for treating patients.