U3 Pharma achieves preclinical proof of concept for U3-1287 (AMG 888)

15-04-2008: U3 Pharma announced that preclinical proof-of-concept has been established for its lead product U3-1287 (AMG 888), the first fully human anti-HER3 monoclonal antibody (mAb). 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.

The target of U3-1287 (AMG 888) is a membrane-bound receptor tyrosine kinase called HER3, the third member of the human epidermal growth factor receptor (HER) family. HER3 controls a key signal transduction pathway in human malignancies and has shown involvement in multiple tumor types of epithelial origin, including breast, lung and colorectal cancers, among others. Using Amgen's Xenomouse(r) technology, U3 Pharma and Amgen generated this fully human anti-HER3 mAb and tested the in vitro and in vivo functional anti-tumor activities in relation to the target. The results showed that this anti-HER3 mAb was able to inhibit the growth of multiple tumor cell lines that are resistant to other HER family inhibitors. Additionally, administration of this anti-HER3 antibody demonstrated statistically significant growth inhibition of established xenograft tumors as a single agent or in combination with other HER family inhibitors.

"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 HER family inhibitors directed against EGFR or HER2," said Dr. Irina Staatz-Granzer, CEO of U3 Pharma. "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," she added.

U3 and Amgen now plan to submit an IND and hope to commence clinical investigations in multiple tumor types later this year.