MacroGenics Announces Removal of Partial Clinical Hold on MGD009 Program by FDA

ROCKVILLE, MD, USA I January 25, 2019 I MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on its Phase 1 monotherapy and combination studies of MGD009, a B7-H3 × CD3 bispecific DART® molecule. Enrollment of new patients in the U.S. has been cleared to proceed with these trials. MacroGenics previously announced on December 7, 2018, that the FDA had placed the program on partial clinical hold following MacroGenics’ reporting of hepatic adverse events on the MGD009 trials to the FDA. During the partial clinical hold, previously enrolled study participants were allowed to continue to receive drug at their pre-assigned dose.

“The MacroGenics team worked diligently and rapidly to provide a comprehensive response to the FDA in late December. As a result, we have been able to resolve the partial clinical hold without significant delay to this clinical program,” stated Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. “The partial clinical hold did not involve our other B7-H3 programs, and, in fact, during the partial hold, we completed enrollment of the first dose escalation cohort for MGC018, our B7-H3-targeted ADC.”

About MGD009

MGD009 is a humanized, bispecific DART molecule that recognizes both B7-H3 and CD3 and has a prolonged serum half-life. B7-H3 is a member of the B7 family of molecules involved in immune regulation and is over-expressed on a wide variety of cancer cells, including cancer stem cells, as well as on the supporting tumor vasculature and underlying tissues, or stroma. The intended mechanism of action of MGD009 is its ability to redirect T cells, via their CD3 component, to kill B7-H3-expressing cells.

In addition to MGD009, MacroGenics’ comprehensive B7-H3 franchise includes enoblituzumab, an Fc-optimized monoclonal antibody, as well as MGC018, an antibody-drug conjugate. These clinical molecules target B7-H3. MacroGenics retains worldwide rights to its franchise of three B7-H3-based molecules.

About MacroGenics, Inc.

MacroGenics is a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics, the MacroGenics logo and DART are trademarks or registered trademarks of MacroGenics, Inc.

SOURCE: MacroGenics

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