- Encouraging initial clinical results from ongoing enoblituzumab (MGA271) trial
- B7-H3 franchise extended — fifth DART® molecule (MGD009) in Phase 1
- Proprietary immune checkpoint PD-1 x LAG-3 DART molecule (MGD013) introduced
- HIV DART and Trident™ tri-specific platform introduced
"The team at
Program Updates and Highlights:
- Enoblituzumab (MGA271). The Company provided an overview of initial data from its ongoing Phase 1 monotherapy clinical study of enoblituzumab, an Fc-optimized monoclonal antibody. To date, enoblituzumab has been well tolerated in patients and has shown encouraging, initial single-agent activity, including tumor regression in multiple, heavily pre-treated patients. In addition, evidence of T-cell immunomodulatory function has been observed in patients treated with enoblituzumab. The Company continues to enroll patients in additional monotherapy Phase 1 study cohorts as well as in two combination studies with either ipilimumab or
pembrolizumab. Data from the ongoing monotherapy study will be presented in a late-breaking abstract session at the 2015
Society for Immunotherapy of Cancer(SITC) Annual Meeting on November 7, 2015.
MacroGenicsdisclosed that MGD009, a Dual-Affinity Re-Targeting (DART) molecule targeting B7-H3 and CD3, has entered into a Phase 1 study in patients and is being evaluated across multiple solid tumor types. MGD009 is designed to target tumors expressing B7-H3 as well as recruit and expand T cells at the tumor site. MacroGenicsretains worldwide development and commercialization rights to MGD009.
- B7-H3 Antibody-Drug Conjugate.
MacroGenicsalso presented pre-clinical data on an antibody-drug conjugate (ADC) program targeting B7-H3. The Company is evaluating several toxin/linker combinations to induce direct killing of B7-H3-positive tumor cells.
MacroGenicsis developing MGD013 to provide co-blockade of two immune checkpoint molecules co-expressed on T cells, PD-1 and LAG-3, for treatment of diseases spanning a wide range of solid tumors and hematological malignancies. The Company presented pre-clinical data on an Fc-bearing DART molecule directed against these targets. In addition to MGD013, MacroGenicsis generating and evaluating multiple other candidates that target a range of immune regulators using its DART and Trident platforms.
MacroGenicspresented pre-clinical data on MGD014, an Fc-bearing DART molecule that targets HIV-infected cells and CD3. MGD014 is being developed to eliminate latent HIV infection in patients treated with continuous anti-retroviral therapy (cART) alone or in combination with latency-reversing agents. MGD014 will be developed under a contract recently awarded by the National Institute of Allergy and Infectious Diseasesfor up to $24.5 million. This is the first infectious disease DART program planned for clinical testing.
R&D Day Webcast
To view the recorded webcast of the Company's R&D Day event as well as download the presentation, please visit the Investor Relations section of MacroGenics' website at http://ir.macrogenics.com/events.cfm.
The development of a DART molecule targeting HIV will be funded in part with Federal funds from the
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
Jim Karrels, Senior 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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