MacroGenics has dosed the first patient in a Phase I study of MGD006 in relapsed or refractory acute myeloid leukemia (AML), marking the first clinical trial of a DART product candidate.
Designed to assess the safety and tolerability of MGD006 in patients with relapsed or refractory AML, the Phase I dose-escalation study will enroll up to 58 patients across multiple sites in the US.
Washington University School of Medicine in St Louis oncology division chief and lead investigator of the study John Di Persio said the study will explore MGD006's ability to redirect T cells against CD123-positive leukemic blasts in patients with relapsed or refractory AML.
"We hope to gain an understanding of the safety, tolerability and activity of MGD006 in this study," Di Persio said.
As well as the primary safety endpoint, the study will also evaluate secondary endpoints of pharmacokinetics and activity.
The study has been initiated at Washington University School of Medicine in St Louis, US, and will also evaluate a number of translational endpoints assessing the immunobiology of MGD006.
MacroGenics president and CEO Scott Koenig said the initiation of the Phase I study marks a significant milestone as the first of the company's portfolio of DART molecules, MGD006, enters the clinic.
"MGD006 has demonstrated great promise as a T cell-re-directed cancer immunotherapy in pre-clinical studies," Koenig said.
"We will see whether these studies translate into clinical trial results indicative of clinical improvement for patients with AML, a disease for which standard therapies have advanced little in the last 30 years."
MGD006 is a humanised, dual-affinity re-targeting (DART(R)) bi-specific antibody-based molecule that binds to both CD123 and CD3, antigens expressed on leukemic cells and T lymphocytes respectively.
MacroGenics has development and commercialisation rights to MGD006 in the US, Canada, Mexico, Japan, South Korea and India while Servier, MacroGenics' partner, has rights to MGD006 in all other countries.
By using a single molecule with dual antibody-like binding regions, MacroGenics' DART platform targets multiple antigens or cells.