"CD19-targeted therapies have generated a great deal of
excitement and based on our pre-clinical data, we believe that
MGD011 has strong potential in the treatment of patients with
certain types of hematological malignancies," said
Pre-Clinical Study Results with MGD011
The pre-clinical studies investigated the ability of MGD011 to mediate anti-tumor activity. These studies demonstrated 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 decrease in circulating B lymphocytes and profound B-cell depletion in lymphoid organs in cynomolgus monkeys following once-a-week dosing. MGD011 was well tolerated at doses up to 100 mcg/kg, the highest dose tested, with modest elevations in serum cytokines but no adverse findings. The results of these pre-clinical studies provide a strong rationale for the clinical development of MGD011 as a molecule for the treatment of B-cell malignancies.
About MGD011
MGD011, a humanized CD19 x CD3 bispecific DART protein, 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 found in many hematological malignancies. MGD011 has been engineered to address half-life challenges posed by other programs targeting CD19 and CD3. This product candidate has an Fc domain, which allows for extended pharmacokinetic properties and convenient dosing at a once-a-week or longer interval. In addition, MGD011 and the Company's other DART molecules that redirect T cells against cancer targets are manufactured using a conventional antibody platform without the complexity of having to genetically modify T cells from individual patients as required by approaches such as chimeric antigen receptor (CAR) T-cells.
About
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Company's filings with the
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CONTACT:Jim Karrels , Vice President,CFO MacroGenics, Inc. 1-301-251-5172, info@macrogenics.comKaren Sharma , Vice PresidentMacDougall Biomedical Communications 1-781-235-3060, ksharma@macbiocom.com
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