UPDATE -- Orgenesis And Pall Corporation Partnership Accomplishes Project Financed by the BIRD Foundation
Orgenesis and Pall Corporation originally received BIRD Grant in 2015 to co-develop a viral transduction production process for the treatment of diabetes.
GERMANTOWN, Md., Dec. 11, 2017 (GLOBE NEWSWIRE) -- Orgenesis Ltd., a wholly-owned subsidiary of Orgenesis Inc., (OTCQB:ORGSD) (“Orgenesis” or the “Company”), a vertically-integrated biopharmaceutical company with expertise and unique experience in gene and cell therapy and regenerative medicine, today announced that Orgenesis and Pall Corporation have completed their joint development program supported by the Israel-U.S. Binational Industrial Research and Development (“BIRD”) Foundation. Orgenesis is focused on developing an innovative autologous cell-based therapy for the treatment of diabetes.
The purpose of the grant was to develop a commercially viable production process for a novel cell therapy for diabetes to support submission of an IND application in the U.S. This process uses viral transduction to transform a patient’s own liver cells into fully functional and physiologically glucose-responsive insulin-producing cells.
"The success of this program is a major milestone as we move towards human clinical trials," said Vered Caplan, Chairperson and Chief Executive Officer of Orgenesis Inc. "Pall's virus and cell production systems, specifically the iCELLis® and Xpansion® single-use bioreactors, are rapidly becoming the industry standard for the manufacturing of advanced gene and cell therapies. We thank Pall Corporation and the BIRD Foundation for providing process development expertise and financial support necessary for our global initiatives in combating diabetes.”
"We believe that this joint effort will provide commercially and clinically viable solutions with upstream and downstream support for the entire workflow. The purified adenoviruses produced for TOX studies using the iCellis® 500 bioreactor were fully functional and comparable to the planar flatware process. Furthermore the viral products showed comparable transduction rates on the target liver cells expanded in the Xpansion® 200 bioreactor,” said Dr. Rachel Legmann, Senior Manager at Pall's Biotech Process Development Lab.
Dr. Efrat Assa Kunik, head of the Israeli development team, added, “We’re very proud to be one of the select companies who’ve received the BIRD grant. This lends further credibility and support to our therapeutic platform in diabetes. We believe that our groundbreaking work with the Pall Corporation and the BIRD Foundation are beneficial to our global initiatives in combating diabetes and are essential for our IND-enabling validation studies.”
About Pall Corporation
Pall Corporation provides cutting-edge products and services to meet the demanding needs of customers discovering, developing and producing biologics, cell and gene therapies and classic pharmaceuticals. The company's membranes and membrane devices optimize detection and sample preparation in the drug research, clinical diagnostics, genomics, and proteomics markets. Pall is a leading provider of automated systems and single-use solutions to pharmaceutical and biotechnology companies -- from upstream, through downstream, to formulation and filling -- and maintains certified ISO9001 manufacturing facilities worldwide. The company's Scientific and Laboratory Services (SLS), Technical Services and Validation Laboratories have been a cornerstone of customer support for more than 30 years providing compatibility studies, extractable/leachable studies, particulate validation and more.
About the BIRD Foundation
The BIRD (Binational Industrial Research and Development) Foundation works to encourage and facilitate cooperation between U.S. and Israeli companies in a wide range of technology sectors and offers funding to selected projects. BIRD has approved over 900 projects over its 37-year history. To date, BIRD's total investment in these projects has been over $300 million and has received approximately $100 million in repayments. BIRD funded projects have generated direct and indirect sales of approximately $10 billion. The BIRD Foundation provides support of up to 50% of a project's budget, or up to $1 million, beginning with R&D and ending with the initial stages of sales and marketing. The Foundation supports projects without receiving any rights in the participating companies or in the project itself. The Foundation shares the risk and requires the investment to be repaid only if the project reaches the sales stage.
About Orgenesis Inc.
Orgenesis is a vertically-integrated biopharmaceutical company with expertise and unique experience in cell therapy development and manufacturing. Through its Israeli subsidiary, Orgenesis Ltd., 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). 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. Through its Belgian subsidiary, MaSTherCell S.A., a global Contract Development and Manufacturing Organization (CDMO), Orgenesis is able to deliver optimized process industrialization capacities to cell therapy organizations, and speed up the arrival of their therapies onto the market. From technology selection to business modeling, GMP manufacturing, process development, quality management and assay development, MaSTherCell's teams are fully committed to helping their clients fulfill their objective of providing sustainable and affordable therapies to their patients. MaSTherCell operates in a validated and flexible facility located in the strategic center of Europe within the Walloon healthcare cluster, Biowin. This integrated approach supports the Company's business philosophy of bringing to market significant life-improving medical treatments. For more information, visit www.orgenesis.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, the development of our regeneration technology as therapeutic treatment for diabetes which could, if successful, be a cure for Type 1 Diabetes; our technology not working as well as expected; our ability to retain key employees; our ability to satisfy the rigorous regulatory requirements for new medical procedures; our competitors developing 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, 2016, 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.
Edison Advisors (investors)
Released December 11, 2017