USA-based biotech firm MacroGenics (Nasdaq: MGNX) has announced that French privately held drugmaker Servier will terminate their collaboration and license agreement entered into seven years ago, 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. The US firm said it plans to advance the development of flotetuzumab, its investigational bispecific CD123 x CD3 DART molecule, in patients with primary refractory acute myeloid leukemia (AML), a difficult-to-treat patient population.
To date, MacroGenics has enrolled 50 patients at the recommended Phase II dose (RP2D) in the Phase I monotherapy study, including 30 patients with primary refractory AML. The updated clinical data from this study will be submitted for presentation at the 2019 American Society for Hematology (ASH) Annual Meeting. MacroGenics plans to meet with the US Food and Drug Administration in the third quarter to discuss future development of flotetuzumab, and to define a potential registration path for this molecule as monotherapy.
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