Magenta’s AML and MDS Drug Trial Put on Hold

The FDA has placed a clinical hold on Magenta Therapeutics’ Investigational New Drug (IND) application for its leukemia and myelodysplastic syndrome drug candidate, MGTA-117.

An antibody-drug conjugate, MGTA-117 is designed to deplete hematopoietic stem cells (HSCs) selectively from patients prior to transplant or HSC-based gene therapy.

Magenta filed an IND in June to begin a phase 1/2 trial. The FDA has now asked the company to develop an additional bioassay to inform dose escalation decisions and safety monitoring.

This was the only clinical hold item identified by the FDA and does not relate to the toxicology or manufacturing of MGTA-117, the company said.