Orgenesis And Hemogenyx Collaborate To Manufacture Hu-PHEC Regenerative Technology

Scaling-up manufacture. Source: Fernando Zhiminaicela, no changes made, CC0 Creative Commons.
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Orgenesis Inc. and Hemogenyx Pharmaceuticals PLC. are collaborating to develop and commercialize Hemogenyx’s Human Postnatal Hemogenic Endothelial (Hu-PHEC) technology.

Founded in 2008, headquartered in Germantown, Maryland, USA, Orgenesis is a vertically-integrated biopharmaceutical company with expertise and unique experience in cell therapy development and support services. The company has a global contract development and manufacturing organization (CDMO) subsidiary, as well as developing its own cell therapy products for diabetes.

Orgenesis’ MaSTherCell Global CDMO subsidiary, delivers optimized process industrialization capacities to cell therapy organizations, reducing time to 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 objectives.

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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.

Hemogenyx Pharmaceuticals PLC was founded in 2013, is headquartered in London, UK, with a wholly owned US operating subsidiary, Hemogenyx LLC, located in Brooklyn, New York at a state-of-the-art research facility.

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 developing two distinct and complementary products centered on the 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. The company has discovery/preclinical-scale expertise to derive Hu-PHEC from bankable sources such as umbilical cord, placenta, or liver biopsy.

According to the terms of the new 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 USD $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.

“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.” – Vered Caplan, CEO of Orgenesis

“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.” – Dr. Vladislav Sandler, CEO & Co-Founder of Hemogenyx