Orgenesis Led Consortium awarded EUR 4M European Innovation Council Pathfinder Grant

• Focus is to develop cost-effective production of autologous induced pluripotent stem cells (iPSCs) using microfluidic technologies and artificial intelligence (AI)

Germantown, Maryland, USA, May 3, 2022 - Orgenesis Inc. (NASDAQ: ORGS) (“Orgenesis” or the “Company”), a global biotech company working to unlock the full potential of cell and gene therapies, today announces a consortium led by one of its subsidiaries, MIDA Biotech, has been approved to receive a grant of EUR 4 million, under the European Innovation Council Pathfinder Challenge Program, supporting cutting-edge science and technology in order to create new market opportunities. The grant is aimed at the development of technologies enabling production of autologous induced pluripotent stem cells (iPSCs) using microfluidic technologies and artificial intelligence (AI). The technologies are expected to speed production of personalized iPSCs, while significantly reducing manufacturing cost. The consortium members include MIDA Biotech B.V. (“MIDA”), DeepMed IO, and Leiden University, with MIDA acting as the leading entity.

“We are honored to receive this prestigious grant to advance technologies for the production of personalized iPSCs that can be utilized for autologous adoptive cancer immunotherapies, hematopoietic stem cell transplantation, and regenerative medicine,” said Vered Caplan, CEO of Orgenesis. “The proprietary process is designed to standardize the GMP production of autologous iPSCs and speed production at a fraction of the current cost. Current processes face numerous challenges, such as lack of reproducibility and high cost due to human involvement. However, we believe we can produce patient-specific IPSCs much faster and at lower cost with a goal of integrating it into our Orgenesis Mobile Processing Units and Labs (“OMPULs”). The OMPULs are designed as multi-purpose, mobile, autonomous GMP facilities that can be rapidly deployed as a standardized industrial cleanroom alternative at or near the point of care. Through this grant, we plan to utilize cutting-edge single cell genomics and bioinformatics research to identify cells of the highest quality and develop a database that we expect will be the basis for AI software to select cells that meet clinical standards. Ultimately, we believe this process holds the potential to enable numerous new therapies that could be more affordable and accessible to patients.”

iPSCs are cells that can be differentiated into any cell type of the body and hold significant potential to cure health problems including degenerative diseases, cancer, cancer therapy associated disease and defective tissues. However, current methodologies are very expensive and therefore prohibit standardized production of a person's own (autologous) iPSCs. Instead, the currently used strategy is to use allogeneic cells, ie cells that are created from donors that match larger populations on the most important immune factors. However, this allogeneic cell matching is not fully comprehensive and therefore will almost always be accompanied by immunosupressions and/or risk of rejection. As a result, the therapeutic potential of these cells is limited.

Cost effective production of autologous iPSCs is mandatory to fully realize the regenerative potential of these cells and the technologies that will be developed by MIDA Biotech and the other consortium members holds the promise of taking a large step in that direction.  

DeepMed IO, is a MedTech company based in the UK and Greece, specializing in the utilization of advanced Machine Learning to deliver state of the art AI pipelines for diagnostic augmentation and personalized medicine. Leiden University, founded in 1575, is one of the leading international research universities in Europe.

HORIZON is the EU’s key funding program for research and innovation. The program facilitates collaboration and strengthens the impact of research and innovation in developing, supporting and implementing EU policies while tackling global challenges.