Orgenesis, a global biotech company working to unlock the full potential of cell and gene therapies, announced that its joint venture (JV) with Theracell Advanced Biotechnology in Greece has been designated a “Priority Investment of Strategic National Importance.” The designation was awarded by Enterprise Greece, the official Greek national investment and trade promotion agency, which is responsible for the allocation of the government funds.

As a result of this designation, the JV will be inducted into Greece’s fast-track licensing and approval process. This is expected to help advance development and clinical use of Theracell’s cell and gene therapies within the point-of-care setting, subject to regulatory requirements. In addition, the JV has been approved to receive a grant of up to €32 million from the Greek government upon its request depending on the JV’s requirements. These funds will be used to accelerate the development of Theracell’s therapies. The funds are also intended to support the 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 good manufacturing practice (GMP) facilities intended to develop, optimize and manufacture cell and gene therapies at the point of care.

This JV builds on an original agreement signed by Orgenesis and Theracell in March 2019. This 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, advanced therapies across its network. These therapies are expected to target a wide range of diseases in 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.

We believe that Enterprise Greece designating this JV a ‘Priority Investment of Strategic National Importance’ illustrates the expanding realization by major international governments and public sector bodies on the importance of developing and delivering cell and gene therapies at the point of care centers. We are thankful for the resources and other support to be invested by the Greek government. We believe that this designation demonstrates Enterprise Greece’s confidence in Orgenesis’ POCare platform to potentially transform the cell and gene therapy market, by bringing life-saving therapies to market in a much more time and cost-effective manner,” said Vered Caplan, CEO of Orgenesis.

In the last two years, the collaboration with Orgenesis in Greece and other territories has been important for Theracell’s aim to advance development of cell and gene therapies for both clinical research and patient treatment utilizing the Orgenesis POCare platform,” said Fotis Sakellaridis, CEO of Theracell. “This supports the goal of providing Greek patients with greater access to these important therapies.”

Theracell: The global vision of the realization of Personalized Medicine

Theracell is a regenerative biotechnology company with operations in Greece, where its laboratories and primary facilities are located. The Company focuses in the areas of autologous cell therapy and regenerative medicine. Theracell has extensive experience in the isolation, processing and application of adipose derived stem cells (ADSCs), as well as somatic cells and has developed a patented platform for tissue engineering and cell therapies in the areas of Dermatology, Chondral Defects and Chronic Kidney Injury and has expanded its activity in the Immuno-Oncology area.