SOURCE: Orgenesis Inc.

June 01, 2016 10:01 ET

Orgenesis and CureCell Create Joint Venture for Contract Development and Manufacturing of Cell Therapy Products in South Korea

GERMANTOWN, MD--(Marketwired - Jun 1, 2016) -  Orgenesis Inc. (OTCQB: ORGS), a fully-integrated cell therapy and regenerative medicine company with a novel therapeutic technology dedicated to converting a patient's own cells into functioning insulin-producing cells as a treatment for diabetes, along with MaSTherCell SA, its wholly-owned, vertically integrated CDMO, specializing in cell therapy development for advanced medicinal products (the "Company"), today announced that it has entered into a joint venture agreement with South Korean-based CureCell Co. Ltd. ("CureCell"). The joint venture will enable the two progressive organizations to collaborate in the contract development and manufacturing of cell therapy products in South Korea.

Orgenesis is a pioneer in the development of technology designed to successfully reprogram human liver cells into glucose-responsive, fully functional, Insulin Producing Cells (IPCs). CureCell is a Korean based company that is focused on developing innovative regenerative therapies for both the Korean and international markets.

"South Korea is one of the top nations in the world for supporting cell therapy and regenerative medicine and CureCell is on the cutting edge of innovation and advancement in this industry," said Vered Caplan, CEO of Orgenesis. "We look forward to collaborating closely with CureCell to drive advanced contract manufacturing initiatives in an effort to deliver new cell therapy products in South Korea and around the world."

The intellectual property included in the license from the Tel Hashomer Hospital in Israel to Orgenesis Ltd., which is a subsidiary of Orgenesis Inc., is not part of this joint venture.

About CureCell Co. Ltd.

CureCell is a Korean based company who is focused on developing innovative regenerative therapies for both the Korean and international markets. CureCell's management has identified several cell-therapy technologies that are developed in Korea in parallel to potential developments in the US and Europe. CureCell will focus on developing foreign technologies in Korea and Asia and in expanding international markets for Korean technologies. CureCell collaborates closely with leading medical and academic facilities aiming to become a market leader in the field of therapeutic development in Korea.

About Orgenesis Inc.

Orgenesis is a cell therapy and regenerative medicine company that is committed to developing a cure for Type 1 Diabetes. In pursuit of this goal, the company has developed and patented a novel technology called "cellular trans-differentiation" that turns an insulin-dependent patient's own liver cells into functional insulin producing cells. Orgenesis has proven that, when exposed ex-vivo to certain pancreatic transcription factors and in specific sequence, human adult liver cells can be transformed into fully functional, beta cell-like insulin producing cells (IPCs). After ex-vivo expansion, the IPCs are re-infused via the portal vein of the diabetic patient. In pre-clinical models of Type 1 Diabetes (Non-Obese Diabetic mice), the re-introduced IPCs remain in the liver, effectively respond to glucose challenge and successfully maintain glycemic homeostasis. In the same NOD model, the implanted IPCs were not subject to auto-immune attack or cellular ablation. Orgenesis plans to initiate P1/2 trials in the next 12-18 months. Orgenesis believes that converting the diabetic patient's own tissue into insulin-producing cells has the potential to overcome the significant issues of donor shortage, cost and exposure to chronic immunosuppressive therapy associated with islet cell transplantation. For more information, visit www.orgenesis.com.

About MaSTherCell SA

MaSTherCell SA (Manufacturing Synergies for Therapeutic Cells), a spin-off from ULB (Université Libre de Bruxelles) launched in 2011, is a technology-driven, quality-minded and customer-oriented Contract Development and Manufacturing Organization (CDMO) specialized in cell therapy development for advanced medicinal products. The company is located in Gosselies, Belgium and provides GMP manufacturing for cell therapy companies. Its mission is to combine expertise, quality systems and infrastructure to help its customers bring highly potent cell therapy products faster to the market. For more information, visit www.masthercell.com.

Notice Regarding Forward-Looking Statements

This press release contains forward-looking statements that involve substantial uncertainties and risks. These forward-looking statements 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, the development of our cell therapy production capabilities, our limited financial resources and our ability to raise the working capital needed to fund the commitments under the joint venture agreements specifically and our development projects and business generally, expectations relating to our technology and that this technology may not as well as expected, our ability to retain key employees; our ability to satisfy the rigorous regulatory requirements for new medical procedures; and competitors may develop better or cheaper alternatives to our products and the risks and uncertainties discussed under the heading "RISK FACTORS" in Item 1 of our Annual Report on Form 10-K for the fiscal year ended November 30, 2015, 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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