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Macrogenics Regains European And Other Regional Rights To Enoblituzumab

The following excerpt is from the company's SEC filing.

Servier does not exercise option to license rights for enoblituzumab in its specified territories

MacroGenics advances enoblituzumab and pursues integrated B7-H3 franchise strategy

ROCKVILLE, MD -- Oct. 28, 2015 — MacroGenics, Inc. (NASDAQ: 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 that Servier has given MacroGenics notice that it will not exercise its option to license regional rights for enoblituzumab (M GA271), a clinical-stage monoclonal antibody targeting B7-H3, a member of the B7 family of immune regulators. As a result, MacroGenics now controls worldwide rights to all programs within its B7-H3 franchise.

"Enoblituzumab is the cornerstone of MacroGenics' B7-H3 franchise, a portfolio of complementary therapeutic product candidates aimed at a promising immune regulatory target," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "As we highlighted at our recent R&D Day, we have significantly expanded our research and development efforts across B7-H3-directed therapies, including the advancement of MGD009, a B7-H3 x CD3 bispecific DART® molecule, into the clinic, as well as research efforts around a B7-H3-targeted antibody drug conjugate. Servier's decision enables us to integrate development and commercial strategies across these assets in the future."

Enoblituzumab is currently being evaluated in patients with a variety of tumor types in three clinical studies, including a monotherapy trial as well as in combination with either ipilimumab or pembrolizumab. In October 2015, MacroGenics provided an overview of initial clinical data from the ongoing monotherapy trial of enoblituzumab. Results presented to date suggest that enoblituzumab is well tolerated and tumor regression has been observed in heavily-treated patients across different tumor types, including prostate and bladder cancer, as well as in melanoma patients who have progressed following treatment with one or more checkpoint inhibitor therapies. In addition, evidence of T-cell immunomodulatory function has been observed in patients treated with enoblituzumab. Data from the ongoing monotherapy trial will be presented as a late-breaking abstract...