MacroGenics, Inc a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, as well as autoimmune disorders and infectious diseases, today announced the advancement of two of its proprietary bispecific DART product candidates. This progress includes: a first patient has been dosed with MGD013, a DART molecule that recognizes PD-1 and LAG-3; and the submission of an Investigational New Drug (IND) application with the FDA for MGD014, a DART molecule that targets HIV-infected cells and CD3. MacroGenics retains worldwide rights to both of these product candidates.
MGD013 recognizes both PD-1 and LAG-3 and was designed to enable the co-blockade of these two immune checkpoint molecules co-expressed on T cells. MGD013 has a prolonged serum half-life and is being developed for the potential treatment of a wide range of cancers, including both solid tumors and hematological malignancies. MGD013 is MacroGenics’ first in a series of product candidates that recognize multiple immune regulator targets as a single recombinant molecule.
MGD014 is a bispecific, Fc-bearing DART molecule that targets HIV-infected cells and CD3-expressing T cells, and is being developed by MacroGenics under a contract awarded in September 2015 by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. NIAID recently notified MacroGenics that it was exercising the first of two options under the HIV contract, funding MacroGenics’ advancement of MGD014 into Phase 1 clinical trials as well as the development and testing of a second DART molecule. Under the exercised option, funding of up to $10.8 million is available to MacroGenics for these development efforts. The second option, if later exercised by NIAID, would provide up to an additional $6.3 million for continued development efforts on one or both molecules. Assuming MGD014 IND clearance by the FDA, the Company believes this molecule will be the first clinical bispecific molecule targeting an infectious agent.
“MacroGenics continues to progress its clinical pipeline, and with the recent advancement of MGD013 and MGD014, there are multiple DART molecules being tested in the clinic across multiple modalities and therapeutic areas,” said Scott Koenig, M.D., Ph.D., President and Chief Executive Officer of MacroGenics.
