Genentech, Inc., GlycArt, a company wholly-owned by Roche, and Roche have entered into a collaboration agreement, including a license from GlycArt to Genentech, for the joint development and commercialization of GlycArt’s GA101 molecule.
The companies will be developing GA101, a humanized anti-CD20 monoclonal antibody engineered to increase both direct- and immune-mediated target cell death, for the potential treatment of hematological malignancies and other oncology-related B-cell disorders such as non-Hodgkin’s lymphoma.
Pablo Umaña, Chief Scientific Officer and co-founder of GlycArt, said, “With its unique mode of action, we believe GA101 has the potential to extend the therapeutic benefit over current standards of care, including treatment for patients who do not respond to current therapies.”
“This collaboration with GlycArt and Roche for the GA101 molecule complements our existing research program and our focus on innovative compounds,” said Hal Barron, M.D., Genentech senior vice president, development and chief medical officer. “We are pleased that through this program we may have the potential to offer a new option to treat patients with hematological malignancies.”
“Our early investment in pioneering technologies continues to provide new hope for patients,” said William M. Burns, CEO Roche Pharmaceuticals. “The exciting work in antibody engineering carried out by our scientists at GlycArt can now be taken to the next stage in developing clinically differentiated treatments.”
In association with this agreement, Genentech, Roche and GlycArt will share certain development costs and Genentech will record $105 million in research and development expense in its third quarter 2008 results. Genentech will receive commercialization rights in the United States.
GA101 is currently in Phase I/II clinical trials for CD20-positive B-cell malignancies, such as non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukemia (CLL). GlycArt and Roche plan to provide an update on Phase I data for GA101 at the American Society of Hematology meeting in December 2008.