U3 Pharma has reported that the preclinical proof-of-concept has been established for its lead product U3-1287, a human anti-HER3 monoclonal antibody.
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In vitro and in vivo studies of U3-1287 (AMG 888), which is being developed in partnership with Amgen, demonstrate that the antibody inhibits oncogenic signaling and proliferation of tumors. U3 and Amgen now plan to submit an investigational new drug application (IND) and hope to commence clinical investigations in multiple tumor types in late 2008.
Irina Staatz-Granzer, CEO of U3 Pharma, said: “Our data suggest that U3-1287 (AMG 888) acting against HER3 has great potential as a novel agent for the treatment of epithelial cancers that are or have become resistant to other human epidermal growth factor receptor (HER) family inhibitors directed against EGFR or HER2. We are eager to start clinical investigations as soon as possible and are optimistic that fully human anti-HER3 antibodies will become an important component in clinical applications and cancer research.”
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