MacroGenics Begins Phase 1 Trial Of MGD006 For Acute Myeloid Leukemia Treatment

(RTTNews) - MacroGenics Inc. (MGNX) reported that a first patient received drug in a Phase 1 study of MGD006 in relapsed or refractory acute myeloid leukemia or AML.

MGD006 is a humanized, Dual-Affinity Re-Targeting or DART bi-specific antibody-based molecule that binds to both CD123 and CD3, antigens expressed on leukemic cells and T lymphocytes, respectively. This marks the first clinical study of a DART product candidate.

"We are very enthusiastic about the initiation of this study in which we will explore MGD006's ability to redirect T cells against CD123-positive leukemic blasts in patients with relapsed or refractory AML," said John Di Persio, M.D., Ph.D., lead investigator and Chief, Division of Oncology, Washington University School of Medicine in St. Louis.

According to Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics, "MGD006 has demonstrated great promise as a T cell-re-directed cancer immunotherapy in pre-clinical studies. 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 thirty years."

MacroGenics has development and commercialization rights to MGD006 in the U.S., Canada, Mexico, Japan, South Korea and India; MacroGenics' partner, Servier, has rights to MGD006 in all other countries.

The Phase 1 dose-escalation study is designed to evaluate the safety and tolerability of MGD006 in patients with relapsed or refractory AML. The study would enroll up to 58 patients across multiple sites in the U.S.