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MacroGenics starts Phase 1 trial of MGD006 for acute myeloid leukemia

MacroGenics has begun a Phase 1 study of MGD006 in relapsed or refractory acute myeloid leukemia (AML) with dosing of the first patient in the trial.

MGD006 is a humanized, 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.

The study, which marks the first clinical trial of a DART product candidate, will assess the safety and tolerability of MGD006 in patients with relapsed or refractory AML.

The Phase 1 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.

The clinical trial will assess the secondary endpoints of pharmacokinetics and activity in addition to the primary safety endpoint.

The study 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 1 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," added Koenig.

MacroGenics has development and commercialisation rights to MGD006 in the US, Canada, Mexico, Japan, South Korea and India while MacroGenics’ partner, Servier, has rights to MGD006 in all other countries.

MacroGenics’ DART platform targets multiple antigens or cells by using a single molecule with dual antibody-like binding regions.