MacroGenics, Inc. MGNX, 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.
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