ROCKVILLE, Md., April 6, 2014 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (Nasdaq:MGNX), a clinical-stage biopharmaceutical company focused on discovering and identifying innovative monoclonal antibody-based therapeutics for the treatment of cancer and autoimmune diseases, today announced the presentation of pre-clinical data demonstrating that MGD007, a dual-affinity re-targeting (DART®) protein, has potent activity against colorectal cancer cells both in vitro and in vivo. The data were presented at the American Association for Cancer Research (AACR) Annual Meeting in San Diego, CA.
MGD007 is designed to redirect the body's T-cells, via their CD3 component, to target gpA33-expressing colon cancer cells. The glycoprotein A33 antigen, or gpA33, is found on over 95% of primary and metastatic human colorectal cancers, including cancer stem cells, which are thought to be responsible for tumor recurrence and metastasis.
"Despite recent advances in cancer therapies, colorectal cancer is the second leading cause of cancer-related deaths in the US, representing a significant unmet medical need," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "We were able to demonstrate that MGD007 has robust activity against human colorectal cancer in murine xenograft models and a favorable pharmacokinetic profile in non-human primates. We believe that these data support continued investigation of MGD007 as a potential therapeutic option for patients with colorectal cancer and look forward to initiating our first-in-human Phase 1 study of this product candidate in the second half of this year."
Key findings from the presentation, "Development of MGD007, a gpA33 x CD3 bi-specific DART for T-cell immunotherapy of metastatic colorectal cancer" include:
- MGD007 mediates potent lysis of gpA33-positive colorectal cancer cell lines in vivo and in vitro;
- Tumor growth inhibition in vivo was observed at doses as low as 4 µg/kg; and
- In non-human primates, four weekly doses of up to 200 µg/kg were well-tolerated with prolonged pharmacokinetics, consistent with that of an Fc-containing molecule.
Background on DART Platform
MacroGenics' DART platform enables the targeting of multiple antigens or cells by using a single molecule with an antibody-like structure. The Company has created over 100 DART-based molecules, or DARTs, which have been configured for the potential treatment of cancer, autoimmune disorders and infectious disease. These DARTs can be tailored for either short or prolonged pharmacokinetics and have demonstrated good stability and attractive manufacturability. The Company has completed in vitro and in vivo proof of concept pre-clinical studies with multiple candidates and expects to advance its first two DARTs into clinical development in 2014.
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 and autoimmune diseases. The company generates its pipeline of product candidates from its proprietary suite of next-generation antibody technology platforms, which it believes improve the performance of monoclonal antibodies and antibody-derived molecules. The company creates both differentiated molecules that are directed to novel cancer targets, as well as "bio-betters," which are drugs designed to improve upon marketed medicines. The combination of MacroGenics' technology platforms and antibody engineering expertise has allowed the company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies.
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 anticipated milestones and future expectations and plans and prospects for the Company 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 Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.
CONTACT: Jim Karrels, Vice President, CFO MacroGenics, Inc. 1-301-251-5172, firstname.lastname@example.org Karen Sharma, Vice President MacDougall Biomedical Communications 1-781-235-3060, email@example.com