Hemogenyx Pharmaceuticals plc , the biopharmaceutical group developing new therapies and treatments for blood diseases, announced 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.

 Hemogenyx Pharmaceuticals is a publicly traded company 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.

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.