MacroGenics, a clinical-stage biopharmaceutical company, said Monday it has begun its Phase 1 study with MGD010, the company’s first Dual-Affinity Re-Targeting molecule being developed for patients with autoimmune disorders.
This 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.
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, MGNX will receive a $3 million milestone payment from its partner, Takeda Pharmaceutical. The two companies entered into an option agreement for the development and commercialization of MGD010 in May 2014. Shares closed Friday at $34.77, with a 52-week range of $17.31 to $39.90, and was inactive pre-market.