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Advances MGD011 into Phase I development
July 28, 2015
By: Kristin Brooks
MacroGenics, Inc. has initiated dosing in a Phase I trial of MGD011 (also known as JNJ-64052781), triggering a $10 million milestone payment from partner Janssen Biotech. MGD011 incorporates MacroGenics’ platform for Dual-Affinity Re-Targeting (DART) to simultaneously target CD19 and CD3 for the potential treatment of B-cell malignancies. The Phase I trial will evaluate the safety, tolerability and preliminary clinical activity of MGD011 when administered to patients with relapsed or refractory B-cell malignancies, including diffuse-large B cell lymphoma, follicular lymphoma, mantle-cell lymphoma, chronic lymphocytic leukemia and acute lymphoblastic leukemia. “Janssen’s use of the DART platform for targeting CD19 provides important validation of our technology,” said Scott Koenig, M.D., Ph.D., president and chief executive officer of MacroGenics. “We continue to be impressed with Janssen’s track record of successfully developing potentially transformative oncology therapies and look forward to the future progress of MGD011 in this Phase I study.” Under the collaboration, dating back to December 2014, MacroGenics licensed MGD011 to Janssen and received a $50 million upfront license fee and a $75 million equity investment by Johnson & Johnson Innovation – JJDC, Inc. Janssen is fully responsible for developing MGD011. MacroGenics is also eligible to receive an additional $565 million in clinical, regulatory and commercialization milestones and royalties on sales.
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