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Orgenesis to Collaborate with The Edith Wolfson Medical Center to Conduct Clinical Study Using Orgenesis’ Proprietary POCare Technologies for the Generation and Expansion of Tumor Infiltrating Lymphocytes

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Orgenesis Inc. (NASDAQ: ORGS) has entered into a Clinical Study Agreement with The Edith Wolfson Medical Center in Israel to conduct a clinical trial focused on validating its proprietary POCare Technologies. These technologies aim to improve the generation and expansion of tumor infiltrating lymphocytes (TIL) for cancer therapies. The automated cell culturing system is designed to simplify and optimize this process, potentially lowering manufacturing costs. Both parties expect this collaboration to advance cell and gene therapy products, providing high-quality solutions for cancer patients worldwide.

Positive
  • Collaboration with The Edith Wolfson Medical Center enhances credibility and validation of POCare Technologies.
  • Development of a novel automated cell culturing system to improve TIL generation and expansion.
  • Potential to lower manufacturing costs and streamline processes for cancer therapies.
Negative
  • None.

GERMANTOWN, Md., June 01, 2020 (GLOBE NEWSWIRE) -- Orgenesis Inc. (NASDAQ: ORGS) (“Orgenesis” or the “Company”), a pioneering, global biotech company committed to accelerating commercialization and transforming the delivery of cell and gene therapies (CGTs) while lowering costs, today announces that it has entered into a Clinical Study Agreement with The Edith Wolfson Medical Center, a leading public hospital in Israel. Under the agreement, the parties will conduct a clinical study with a goal of utilizing and validating a number of Orgenesis’ proprietary POCare Technologies, including a novel, automated cell culturing system, designed to enable a faster, safer and metabolically optimized culturing and expansion process for the generation and expansion tumor infiltrating lymphocytes (TIL) for use in adoptive T-cell therapies.

The goal of the cell culturing system is to provide an innovative and simplified method for TIL generation and expansion in an automated and controlled system from the initial TIL production to final product with minimal human operation.

Vered Caplan, CEO of Orgenesis, stated, “Partnering with Edith Wolfson Medical Center, an established and well-respected medical institution, to conduct this clinical trial will further validate our cell processing system for TIL generation and expansion. These POCare Technologies are not only highly versatile, but also highly expandable and as a result, could increase our ability to grow various types of cells for a broad range of customer needs. This latest collaboration is a further illustration of Orgenesis’ commitment to advance novel cell therapies and develop new approaches to immune-oncology in a cost effective, high quality and scalable manner through our CGT Biotech Platform.  Orgenesis will deploy these solutions across its POCare Network. This network includes a growing number of leading medical institutions around the world, including our newly formed collaboration with Hospital Infantil Universitario Niño Jesús, Madrid.”

Dr. Ronen Brenner, Head of the Oncology Division at The Edith Wolfson Medical Center, commented, “We look forward to collaborating with Orgenesis on this important clinical trial to advance and validate this breakthrough Orgenesis proprietary TILs technology, with the joint goal of reducing manufacturing costs and bringing new, cell and gene therapy products to cancer patients worldwide.”

About Edith Wolfson Medical Center
The Edith Wolfson Medical Center is a public hospital (NGO) founded in 1980 and qualified partner medical institution for the conduct of clinical trials. The Edith Wolfson Medical Center is affiliated with the Sackler school of medicine, Tel Aviv University, and possesses all services necessary for carrying out clinical trials, including advanced imaging, pharmacy, and laboratory services. Studies are conducted in the hospital in all fields of medicine, particularly in the areas of oncology, cardiology, neurology, urology, gastroenterology, diabetes, blood lipids, and more. Centers of excellence of the hospital include: pediatric cardiac surgery, pediatric neurology, medical oncology, stroke hospitalization unit, pediatric gastroenterology, a National Center for Victims of Sexual Assault and Parkinson's disease neuroimaging. Additional information is available at: www.wolfson.org.il/

About Orgenesis
Orgenesis is a pioneering global biotech company which is unlocking the full potential of personalized therapies and closed processing systems through its Cell & Gene Therapy Biotech Platform, with the ultimate aim of providing life changing treatments at the Point of Care to large numbers of patients at low cost. The Platform consists of: (a) POCare Therapeutics, a pipeline of licensed cell and gene therapies (CGTs), and proprietary scientific knowhow; (b) POCare Technologies, a suite of proprietary and in-licensed technologies which are engineered to create customized processing systems for affordable point of care therapies; and (c) POCare Network, a collaborative, international ecosystem of leading research institutes and hospitals committed to clinical development and supply of CGTs at the point of care. By combining science, technologies and a collaborative network, Orgenesis is able to identify the most promising new therapies and provide a pathway for them to reach patients more quickly, more efficiently and at scale, thereby unlocking the power of cell and gene therapy for all. Additional information is available at: 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, our ability to effectively use the net proceeds from the sale of Masthercell, our ability to achieve and maintain overall profitability, the development of our POCare strategy, the sufficiency of working capital to realize our business plans, the development of our transdifferentiation technology as therapeutic treatment for diabetes which could, if successful, be a cure for Type 1 Diabetes; our technology not functioning as expected; our ability to retain key employees; our ability to satisfy the rigorous regulatory requirements for new procedures; our competitors developing better or cheaper alternatives to our products 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 2019, 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.

Contact for Orgenesis:
Crescendo Communications, LLC
Tel: 212-671-1021
Orgs@crescendo-ir.com


FAQ

What clinical trial is Orgenesis conducting with The Edith Wolfson Medical Center?

Orgenesis is conducting a clinical trial to validate its proprietary POCare Technologies for the generation and expansion of tumor infiltrating lymphocytes (TIL) for cancer therapy.

What is the goal of the automated cell culturing system developed by Orgenesis?

The goal is to provide a simplified and optimized method for TIL generation and expansion, enhancing safety and efficiency.

How might the clinical trial impact Orgenesis' stock symbol ORGS?

Successful validation of POCare Technologies could positively impact investor sentiment and the stock's performance by showcasing advancements in cancer therapies.

When was the Clinical Study Agreement with The Edith Wolfson Medical Center announced?

The Clinical Study Agreement was announced on June 01, 2020.

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