Made Scientific, a US-based cell therapy contract development and manufacturing organisation (CDMO), and Hemogenyx Pharmaceuticals, a clinical-stage biopharmaceutical company developing targeted therapies for the treatment of hematologic malignancies and other life-threatening diseases, have announced a manufacturing partnership to advance HG-CT-1, Hemogenyx's Chimeric Antigen Receptor T-cell (CAR-T) therapy and lead clinical program for the treatment of relapsed/refractory acute myeloid leukaemia (r/r AML) in adults.

Under the agreement, Hemogenyx will leverage Made Scientific's specialised expertise in CAR-T cell therapy technology transfer and manufacturing at its GMP facilities in Newark and Princeton, NJ, which are equipped for both clinical and commercial manufacturing.

The collaboration will advance Hemogenyx's ongoing Phase I clinical trial of HG-CT-1 in adult patient cohorts and support the potential inclusion of additional cohorts for pediatric r/r AML patients. Hemogenyx has already made significant progress in the trial, with early clinical data supporting growing confidence in both safety and potential efficacy.

Syed T. Husain, Chairman and CEO of Made Scientific, commented, “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 and Co-Founder of Hemogenyx Pharmaceuticals, said, “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.”