Takeda announced in a press release that it has partnered with MacroGenics to develop and commercialize MGD010 for the treatment of autoimmune diseases. The collaboration centers around MacroGenics’ proprietary Dual-Affinity Re-Targeting (DART) technology that simultaneously engages CD32B and CD79B, two B-cell surface proteins.
Scott Koenig, President and CEO of MacroGenics, said that the partnership with Takeda is the fifth DART collaboration and the first autoimmune DART program headed to clinical trials. Tetsuyuki Maruyama, General Manager of the Pharmaceutical Research Division at Takeda said, “We believe bi-specific antibodies are an important new frontier in medicine that may unlock additional therapeutic options for patients in the future.”
MacroGenics and Takeda
The agreement between MacroGenics and Takeda calls for Takeda to make an upfront payment of $15 million to MacroGenics, which will conduct development activities until the completion of the Phase Ia study. At that time, Takeda can exercise its option to obtain an exclusive worldwide license for MGD010, paying MacroGenics an option exercise fee. For clinical, regulatory, and commercial successes, MacroGenics is due additional funds, up to $500 million total. MacroGenics has the option to co-market MGD010 in North America.
MGD010 uses MacroGenics’ DART platform to engage B-cell surface proteins. B-cell therapies currently have limitations due to B cell depletion and delayed action onset. Pre-clinical studies have shown that MGD010 can modulate B cells without depleting them. Normally, CD32B helps B cell regulation to prevent autoimmune disease, so MGD010 uses this mechanism to block B cells that make pathogenic antibodies. In Systemic Lupus Erythematosus (SLE) studies, MGD010 blocked B cell activation. In non-human primate studies, the agent showed a favorable pharmacological profile and safety profile.
MacroGenics' DART platform uses a single molecule to target multiple antigens or cells. The company has made over 100 DART molecules with an antibody-like structure. Its molecules show promise for the treatment of autoimmune disorders, cancer, and infectious disease. MacroGenics says that the molecules show stability and good manufacturability. They can be engineered for short or prolonged action. MacroGenics has other DART partnerships with pharmaceutical companies including Pfizer, Boehringer Ingelheim, Gilead, and Servier.