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Reports of fragmentary Clinical hold on MGD009 Phase 1 study by Macrogenics (MGNX)

Updated: Dec 12, 2018

Macrogenics, Inc. is a biopharmaceutical company at the clinical stage, it is targeting for discovering and developing a monoclonal antibody-based therapeutic system for cancer treatment. This organization made an announcement on December 6th stipulating that they have received a letter from USFDA in which they have put some kind of restriction on Mono-therapy study of MGD009 Phase 1, which is a B7-H3 x CD3 bispecific DART ® molecule along with MGD009 and MGA012 (anti-PD-1) combination study. Until the restriction is lifted by USFDA no new patients can be enrolled in these studies. The existing participants may continue to get the pre-decided dose of the drug.

This incomplete restriction was followed by Macrogenics’ reporting to USFDA about the hepatic adverse events on the MGD009 mono-therapy trial to FDA. In also included the reversible increase of the level of transaminase; including/not including the increase in the level of bilirubin. These adverse may have been non-complicated and short termed. In order to alleviate these symptoms, Macrogenics has told FDA that they plan to alter the existing MGD009 studies by providing additional supportive care. The FDA has put some hold on the trials, review of the additional details regarding these events have been pending and satisfactory review of planned alteration to the mono-therapy and combination study protocol is done. Macrogenics will be closely working with FDA to analyze these events and look for the solution to resolve clinical hold.

"The safety of the participants under study is the top concern of Macrogenics in conducting clinical trials” said Scott Koeing, M.D., Ph.D. He also added "As we have been recognized to the FDA, we feel that transaminitis caused in patients administering MGD009 was a cytokine-mediated step. We are reviewing this with FDA and will provide an update when we have some more information. This fragmentary hold will not impact ongoing clinical studies for enoblituzumab and MGC018, which are our other B7-H3 targeted molecules.