"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.
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.
Cautionary Note on Forward-Looking Statements
Any statements in this press release about future expectations,
plans and prospects for the Company, including statements about the
Company's strategy, future operations, clinical development of the
Company's therapeutic candidates, milestone or opt-in payments from
the Company's collaborators, the Company's future expectations and
plans and prospects and other statements containing the words
"anticipate," "believe," "estimate," "expect," "intend," "may,"
"plan," "predict," "project," "target," "potential," "will,"
"would," "could," "should," "continue," and similar expressions,
constitute forward-looking statements within the meaning of The
Private Securities Litigation Reform Act of 1995. Actual results
may differ materially from those indicated by such forward-looking
statements as a result of various important factors, including: the
uncertainties inherent in the initiation and enrollment of future
clinical trials, expectations of expanding ongoing clinical trials,
availability and timing of data from ongoing clinical trials,
expectations for regulatory approvals, other matters that could
affect the availability or commercial potential of the Company's
product candidates and other risk factors described in the
Company's filings with the
Jim Karrels, Vice President, CFO MacroGenics, Inc.1-301-251-5172, firstname.lastname@example.org Karen Sharma, Vice President MacDougall Biomedical Communications1-781-235-3060, email@example.com
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