Orgenesis Announces Collaboration with Hemogenyx to Develop Blood Stem Cell Replacement Product

GERMANTOWN, Md., Oct. 22, 2018 (GLOBE NEWSWIRE) -- Orgenesis Inc. (NASDAQ: ORGS), a manufacturer, service provider and developer of advanced cell therapies, today announced it has entered into a collaboration agreement with Hemogenyx Pharmaceuticals Plc (LSE: HEMO) to collaborate on the development and commercialization of Hemogenyx's Human Postnatal Hemogenic Endothelial (Hu-PHEC) technology. Hu-PHEC is a cell replacement product candidate that is being designed to generate cancer-free, patient-matched blood stem cells after transplantation into the patient.

According to the terms of the agreement, Orgenesis shall manufacture and supply all Hu-PHEC related products both during and following completion of clinical trials. Orgenesis shall also receive the worldwide rights to market the products and shall serve as a global distributor of Hemogenyx's Hu-PHEC related products.

In consideration for the license, Orgenesis and/or its affiliates will advance to Hemogenyx a convertible loan in an amount of no less than $1.0 million for advancing the development of the Hu-PHEC technology. Orgenesis shall also pay a royalty of 12% of Orgenesis' net revenues resulting from the sale or licensing of products involving the use of Hemogenyx's Hu-PHEC technology. 

Vered Caplan, Chief Executive Officer, stated, "We are excited to expand our collaboration with Hemogenyx, as this Hu-PHEC technology addresses a sizable and underserved market.  Sadly, for patients suffering from diseases such as leukemia and lymphoma, as well as severe autoimmune diseases, a bone marrow transplant is often necessary.  However, this procedure also carries risks of toxicity and death.  Through this novel platform, our goal is to develop cancer-free hematopoietic stem cells (HSC) for use in transplants to treat blood cancers and other conditions with superior results.  We look forward to building upon the expertise we developed the past few years, including transdifferentiation and manufacturing of liver cells, as we expand into development and industrialization of additional products."

Dr. Vladislav Sandler, CEO & Co-Founder of Hemogenyx, commented: "As a company committed to the discovery and development of novel therapeutic products for patients suffering from blood and severe autoimmune diseases, we are pleased to partner with Orgenesis, a premier service provider in the regenerative medicine industry and a pioneer in cell reprogramming. The collaboration agreement is a testimony of the value of Hemogenyx' Hu-PHEC technology."

About Hemogenyx Pharmaceuticals Plc

Hemogenyx Pharmaceuticals PLC. is a publicly traded company (LSE: HEMO) headquartered in London, with its wholly owned US operating subsidiary, Hemogenyx LLC, located in Brooklyn, New York at its state-of- the- art research facility ("Hemogenyx"). For more than 50 years, bone marrow transplantation has been used to save the lives of patients suffering from blood diseases. The risk of toxicity and death that are associated with bone marrow transplantation, however, have meant that the procedure is used only as a last resort and its use is restricted. Hemogenyx's technology has the potential to enable many more patients suffering from devastating blood diseases, such as leukemia and lymphoma, as well as severe autoimmune diseases, such as multiple sclerosis, aplastic anemia and systemic lupus erythematosus (Lupus), to benefit from bone marrow transplantation. Hemogenyx is a pre-clinical stage biopharmaceutical group developing new medicines and treatments to bring the curative power of bone marrow transplantation to a greater number of patients suffering from otherwise incurable life-threatening diseases. Hemogenyx is developing two distinct and complementary products, as well as a platform technology that it uses as an engine for novel product development.

About Orgenesis
Orgenesis is a vertically-integrated biopharmaceutical company with expertise and unique experience in cell therapy development and support services.  Through its Israeli subsidiary, Orgenesis Ltd., Orgenesis is developing 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 Masthercell Global subsidiary, 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, and quality management, 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 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, the success of our reorganized CDMO operations, the success of our partnership with Great Point Partners, our ability to achieve and maintain overall profitability, 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 November 30, 2017, 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:
David Waldman
Crescendo Communications, LLC
Tel: 212-671-1021
Orgs@crescendo-ir.com

To read more Press Release articles, click here.