Made Scientific, a prominent U.S.-based cell therapy contract development and manufacturing organization (CDMO), has joined forces with Hemogenyx Pharmaceuticals plc, a clinical-stage biopharmaceutical firm focused on innovative therapies for severe diseases, to further the development of HG-CT-1. This Chimeric Antigen Receptor T-cell (CAR-T) therapy is the lead program aimed at treating relapsed/refractory acute myeloid leukemia (r/r AML) in adults.

As part of this agreement, Hemogenyx will utilize Made Scientific's specialized expertise in CAR-T cell therapy technology transfer and manufacturing capabilities at its GMP facilities located in Newark and Princeton, NJ. These facilities are equipped to handle both clinical and commercial manufacturing processes. The partnership is set to advance the ongoing Phase I clinical trial of HG-CT-1, which includes adult patient cohorts and explores the possibility of adding pediatric r/r AML patients to the study.

Hemogenyx has made notable strides in the trial, with initial clinical data bolstering confidence in the safety and potential effectiveness of the therapy. Syed T. Husain, Chairman & CEO of Made Scientific, remarked, "Our collaboration with Hemogenyx reflects Made Scientific's commitment to advancing next-generation cell therapies that address urgent, unmet medical needs. Through our integrated development and manufacturing solutions and highly experienced team, we are proud to support Hemogenyx as they advance HG-CT-1 in their Phase I clinical trial."

Dr. Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, emphasized the importance of this collaboration, stating, "Partnering with a trusted CDMO like Made Scientific is essential to the success of HG-CT-1, our lead CAR-T therapy. Made's expertise in cell therapy manufacturing will be instrumental in driving the continued progress of this potential breakthrough therapy for patients with relapsed or refractory AML."

This partnership aligns with Made Scientific's mission to "Defy Limits. Deliver Results." and highlights the growing intersection of cell therapy development and manufacturing expertise in addressing critical health challenges.