Macrogenics To Receive $3M Milestone Payment From Topeka, Initiates Phase 1 Study Of MGD010

MacroGenics, Inc.

, a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, as well as autoimmune disorders and infectious diseases, today announced the initiation of a Phase 1 study with MGD010, its first Dual-Affinity Re-Targeting (DART®) molecule being developed for patients with autoimmune disorders. MGD010 is a bi-specific molecule that simultaneously targets CD32B and CD79B, two B-cell surface proteins, for the treatment of autoimmune disorders. MGD010 is designed to inhibit B-cell activation by exploiting the inhibitory function of CD32B, a checkpoint molecule expressed by B cells. As a result of the study initiation, MacroGenics will receive a $3 million milestone payment from its partner, Takeda Pharmaceutical Company Limited. "The initiation of this Phase 1 study marks the advancement of our third DART program into clinical development," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "MGD010 has been shown to inhibit B-cell activation by a novel dual-targeting mechanism without depleting B cells in pre-clinical models. We believe this molecule has the potential to address features that limit currently approved B-cell-targeted therapies, including delayed onset of action and prolonged depletion of antibody-producing B cells and thus, potentially treat a broader population of patients with autoimmune disorders." The recently-initiated Phase 1 clinical trial is a first-in-human, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of MGD010 in healthy subjects.