MacroGenics provides update on flotetuzumab program
MacroGenics announced that it plans to advance the development of flotetuzumab, its investigational bispecific CD123 x CD3 Dart molecule, in patients with primary refractory acute myeloid leukemia, or AML. MacroGenics has enrolled 50 patients at the recommended Phase 2 dose, or RP2D, in the Phase 1 monotherapy study, including 30 patients with primary refractory AML. The updated clinical data from this study will be submitted for presentation at the American Society for Hematology, or ASH. MacroGenics plans to meet with the FDA in Q3 to discuss future development of flotetuzumab, and to define a potential registration path for this molecule as monotherapy. In parallel, MacroGenics plans to initiate a study in relapsed or refractory AML patients combining flotetuzumab with MGA012, a proprietary anti-PD-1 antibody, as a potential means to both broaden and lengthen the duration of response of AML patients on flotetuzumab. The combination is supported by a scientific rationale based on data previously reported by MacroGenics. The company is positioned to begin to enroll patients imminently. MacroGenics and Laboratoires Servier will terminate their collaboration and license agreement, with an effective date of January 15, 2020, unless sooner agreed to by the parties. As a result, MacroGenics will regain full global rights to develop and commercialize flotetuzumab. MacroGenics entered into an agreement with Servier in September 2012 to develop and commercialize flotetuzumab and other earlier stage Dart molecules, in all regions other than North America, Japan, South Korea and India. Servier recently informed MacroGenics of its intention to terminate the agreement.