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MGD019 is intended to enable co-blockade of two immune checkpoint molecules co-expressed on T cells, PD-1 and CTLA-4, with a single agent. MGD019 is a DART® molecule that recognizes both PD-1 and CTLA-4 on T cells and has a prolonged serum half-life. We anticipate that MGD019 could be used for the treatment of a wide range of solid tumors. MGD019 is the second product candidate that recognizes multiple immune regulator targets, the first being MGD013, which targets PD-1 and LAG-3. We anticipate submitting the Investigational New Drug (IND) application for MGD019 in 2018.
At the 2017 SITC Annual Meeting, MacroGenics highlighted pre-clinical data showing that MGD019 binds to and blocks its targets with increased activity on dual PD-1/CTLA-4-expressing cells. MGD019 enhances T-cell responses in vitro to the level achieved by a combination of replicas of nivolumab and ipilimumab. Furthermore, MGD019 was well tolerated in cynomolgus monkeys with a safety profile similar to that observed with PD-1 blockade alone while demonstrating biological effects of CTLA-4 antagonism.
MacroGenics retains full worldwide rights to MGD019.