US-Greek Venture gets €32m cash injection

As a result of this designation, the Greek regemed specialist and the US specialist for automated local production of autologous cell therapies will be included into Greece’s fast-track licensing and approval process. This is expected to help advance development and clinical use of Theracell’s autologous cell and gene therapies within the point-of-care setting, subject to regulatory requirements.

The joint ventrue will also receive funding of up to €32m from the Greek government to accelerate the development of Theracell’s therapies. Paricularly, the fund will be used to  speed up process development and manufacturing of the therapies at the clinical sites, utilizing Orgenesis’ Mobile Processing Units and Labs (“OMPULs”). OMPULs are multi-purpose mobile autonomous GMP-compliant facilities intended to develop, optimise and manufacture cell and gene therapies at the point of care.

The partnership builds on an agreement signed by Orgenesis and Theracell in March 2019 that was extended in December 2019, with a strategic partnership agreement to implement Orgenesis’ POCare cell therapy platform for clinical development and commercialization of cell and gene therapies within public and private hospitals in Greece.

The new program has been constructed with the intention to provide the Greek National Health System with resources to specifically advance clinical development and deliver personalized cell-based and regenerative therapies from oncology, hematology and other serious unmet medical needs. The program aims to provide patients in Greece with cell and gene therapy treatments that are affordable, available and accessible.