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MGD011 (also known as JNJ-64052781), a humanized CD19 x CD3 bispecific Dual-Affinity Re-Targeting, or DART®, molecule, is being developed for the treatment of B-cell hematological malignancies. CD19, a lymphocyte-specific marker expressed from early B-lymphocyte development through mature memory B cells, is highly represented in B-cell malignancies. This makes it attractive for targeted interventions. MGD011 is designed to redirect T cells, via their CD3 component, to eliminate CD19-expressing cells. MGD011 has been engineered to address half-life challenges posed by other programs targeting CD19 and CD3. This product candidate is designed to have a prolonged serum half-life and convenient dosing at an interval of once-every-two-weeks.
In July 2015, Janssen Biotech, Inc. (Janssen) initiated dosing in a Phase 1 trial of MGD011. The purpose of this first-in-human, open-label study is to 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.
MacroGenics presented the results of pre-clinical studies at the 2014 Annual Meeting of the American Society of Hematology. These studies demonstrated that MGD011 mediates potent anti-tumor activity in vitro and in mouse leukemia/lymphoma tumor models, with high complete response rates and no evidence of relapse over the study duration. MGD011, whose components cross-react with the corresponding cynomolgus monkey antigens, displayed prolonged pharmacokinetic properties in this species, consistent with that of a monoclonal antibody. Treatment with MGD011 induced durable, marked decreases in circulating B lymphocytes and profound B-cell depletion in lymphoid organs in cynomolgus monkeys following once-a-week dosing. MGD011 was well tolerated. (Learn More: 2014 ASH Presentation)
In December 2014, MacroGenics entered into a collaboration agreement with Janssen, in which it licensed worldwide rights to Janssen. MacroGenics may elect to fund a portion of late-stage clinical development in exchange for a profit share in the U.S. and Canada. If commercialized, MacroGenics would be eligible to receive royalties on any global net sales and has the option to co-promote the molecule with Janssen in the U.S. (Learn More: Janssen MGD011 Collaboration)