Orgenesis (NASDAQ:ORGS) Inc announced that its joint venture (JV) with Theracell Advanced Biotechnology SA in Greece has been designated a “Priority Investment of Strategic National Importance.”
The global biotech company noted that 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 the designation, it said the JV will be inducted into Greece’s fast-track licensing and approval process. This is expected to help advance the development and clinical use of Theracell’s cell and gene therapies within the point-of-care setting, subject to regulatory requirements.
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In addition, Orgenesis (NASDAQ:ORGS) said 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 (NASDAQ:ORGS) 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.
“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,” Orgenesis CEO Vered Caplan said in a statement.
“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.”
Orgenesis said the JV builds on an original agreement signed by Orgenesis and Theracell in March 2019, which 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.
It said 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.
“Greece is pushing ahead as a regional technological hub where entrepreneurship drives innovation and technological advancement,” Caplan added.
“Theracell has proven to be an ideal partner for Orgenesis, contributing extensive experience and capabilities in autologous cell therapy and regenerative medicine, with operations in Greece and strong relationships throughout the region.
“At the same time, we remain focused on establishing and expanding additional POCare locations and partnerships with hospitals and healthcare networks in other countries and regions around the world.”
Theracell noted that in the last two years, the collaboration with Orgenesis in Greece and other territories has been important for its aim to advance the development of cell and gene therapies for both clinical research and patient treatment utilizing the Orgenesis POCare platform.
“We thank Enterprise Greece for its trust in our program,” Theracell CEO Fotis Sakellaridis said.
“We believe that the Greek government is providing essential support required to position Greece as a center of medical innovation in Southeast Europe.
“Most importantly, this supports the goal of providing Greek patients with greater access to these important therapies.”
Orgenesis is a global biotech company working to unlock the full potential of cell and gene therapies in an affordable and accessible format at the point of care.
The Orgenesis POCare Platform is comprised of three enabling components: a pipeline of licensed POCare Therapeutics that are processed and produced in closed, automated POCare Technology systems across a collaborative POCare Network.
Contact the author at stephen.gunnion@proactiveinvestors.com