Orgenesis Led Consortium Awarded €4M European Innovation Council Pathfinder Grant

GERMANTOWN, Md., May 03, 2022 (GLOBE NEWSWIRE) -- 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 €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.

About Orgenesis

Orgenesis is a global biotech company working to unlock the full potential of cell and gene therapies (CGTs) 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. Orgenesis identifies promising new therapies and leverages its POCare Platform to provide a rapid, globally harmonized pathway for these therapies to reach and treat large numbers of patients at lowered costs through efficient, scalable, and decentralized production. The POCare Network brings together patients, doctors, industry partners, research institutes and hospitals worldwide to achieve harmonized, regulated clinical development and production of the therapies. www.orgenesis.com.

Notice Regarding Forward-Looking Statements

This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended. These forward-looking statements involve substantial uncertainties and risks and are based upon our current expectations, estimates and projections and reflect our beliefs and assumptions based upon information available to us at the date of this release. We caution readers that forward-looking statements are predictions based on our current expectations about future events. These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions that are difficult to predict. Our actual results, performance or achievements could differ materially from those expressed or implied by the forward-looking statements as a result of a number of factors, including, but not limited to, our reliance on, and our ability to grow, our point-of-care cell therapy platform and OMPUL business, our ability to achieve and maintain overall profitability, our ability to manage our research and development programs that are based on novel technologies, our ability to control key elements relating to the development and commercialization of therapeutic product candidates with third parties, the timing of completion of clinical trials and studies, the availability of additional data, outcomes of clinical trials of our product candidates, the potential uses and benefits of our product candidates, our ability to manage potential disruptions as a result of the COVID-19 pandemic, the sufficiency of working capital to realize our business plans and our ability to raise additional capital, the development of our POCare strategy, our trans differentiation technology as therapeutic treatment for diabetes, the technology behind our in-licensed ATMPs not functioning as expected, our ability to further our CGT development projects, either directly or through our JV partner agreements, and to fulfill our obligations under such agreements, our license agreements with other institutions, our ability to retain key employees, our competitors developing better or cheaper alternatives to our products, risks relating to legal proceedings against us and the risks and uncertainties discussed under the heading "RISK FACTORS" in Item 1A of our Annual Report on Form 10-K for the fiscal year ended December 31, 2021, and in our other filings with the Securities and Exchange Commission. We undertake no obligation to revise or update any forward-looking statement for any reason.

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