Partnership with WuXi Advanced Therapies to manufacture lentiviral vectors for phase I trial of cutting edge HEMO-CAR-T programme
Hemogenyx Pharmaceuticals will leverage WuXi Advanced Therapies’ (“WuXi ATU”) plasmid and lentiviral vector manufacturing platforms, including integrated testing, to accelerate HEMO-CAR-T programme for acute myeloid leukaemia (“AML”) toward phase I clinical trials.
Hemogenyx Pharmaceuticals plc (LSE: HEMO), the biopharmaceutical group developing new therapies and treatments for blood diseases, is pleased to announce the commencement of a strategic manufacturing partnership with WuXi ATU, a global contract testing development and manufacturing organisation (“CTDMO”).
HEMO-CAR-T cells are made using the Company’s proprietary humanised monoclonal antibody against a target on the surface of AML cells. This cutting-edge application of cell-based immune therapy offers a potentially more benign and effective form of therapy that, if successful, could have a major impact on treatment and survival rates for AML. HEMO-CAR-T is planned to be the Company’s first therapeutic candidate to enter clinical trials.
Hemogenyx Pharmaceuticals will leverage WuXi ATU’s Good Manufacturing Process (“GMP”) plasmid production and lentiviral vector manufacturing and testing platforms to accelerate the development of HEMO-CAR-T and provide clinical materials to support regulatory filing and preparation for clinical trials.
Dr Vladislav Sandler, Chief Executive Officer and co-founder of Hemogenyx Pharmaceuticals commented, “We are delighted to partner with WuXi ATU, and access its integrated plasmid and lentiviral vector platforms, expertise and GMP manufacturing capabilities. The agreement is key to advancing our HEMO-CAR-T programme into clinical trials and accelerating the timeline to deliver this innovative therapy to patients in need of a more benign and effective treatment for AML.”
Dr David Chang, CEO of WuXi ATU, added, “There’s an urgent clinical need for effective treatments for AML, and WuXi ATU is proud to manufacture and test the lentiviral vectors that Hemogenyx Pharmaceuticals requires to accelerate the beginning of its first clinical trial for this indication. We hope that the HEMO-CAR-T programme will have a lasting impact for patients with AML.”
WuXi ATU has initiated the plasmid manufacturing process for Hemogenyx Pharmaceuticals and the Company anticipates filing an Investigational New Drug (“IND”) application in 2022.
About Hemogenyx Pharmaceuticals plc
Hemogenyx Pharmaceuticals is a publicly traded company (LSE: HEMO) headquartered in London, with its US operating subsidiaries, Hemogenyx Pharmaceuticals LLC and Immugenyx LLC, located in New York City at its state-of-the-art research facility.
The Company is a pre-clinical stage biopharmaceutical group developing new medicines and treatments to treat blood and autoimmune disease and to bring the curative power of bone marrow transplantation to a greater number of patients suffering from otherwise incurable life-threatening diseases. Hemogenyx Pharmaceuticals is developing several distinct and complementary product candidates, as well as a platform technology that it uses as an engine for novel product development.
For more than 50 years, bone marrow transplantation has been used to save the lives of patients suffering from blood diseases. The risks of toxicity and death that are associated with bone marrow transplantation, however, have meant that the procedure is restricted to use only as a last resort. The Company’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.
About WuXi Advanced Therapies (ATU)
WuXi Advanced Therapies, a global Contract Testing Development and Manufacturing Organisation (CTDMO), is the advanced therapies business unit of WuXi AppTec and offers integrated platforms to transform the discovery, development, testing, manufacturing, and commercialization of cell and gene therapies for customers worldwide. Our technologies, automation platforms and service solutions advance pre-clinical research and accelerate the timeline to GMP manufacture, while integrated GMP manufacturing and testing platforms reduce time to market, maintaining high titres, high levels of quality assurance and full regulatory compliance. Ultimately, our complete end-to-end solutions support pioneering companies to to deliver breakthrough cell and gene therapies to the patients who need them. For more information, please visit https://www.advancedtherapies.com.
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Dr Vladislav Sandler, Chief Executive Officer & Co-Founder
Peter Redmond, Director
WuXi Advanced Therapies
Sophie Lutter, Head of Marketing and Communications
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