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Millennium Initiates First Clinical Trial with the First Oral Proteasome Inhibitor

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The Takeda Oncology Company has announced it has further expanded its protein homeostasis program with the initiation of a Phase I clinical trial for an oral formulation of MLN9708, the Company’s second-generation proteasome inhibitor. An intravenous formulation of MLN9708 entered clinical trials in March.

MLN9708 is the third molecule Millennium has developed from its research in protein homeostasis. VELCADE. (bortezomib) for Injection, the first-in-class proteasome inhibitor developed by Millennium, is currently approved for patients with multiple myeloma, and patients with mantle cell lymphoma who have received at least one prior therapy. It is said to be the only proteasome inhibitor on the market today.

Last year, Millennium initiated Phase I clinical trials of MLN4924, which targets the Millennium discovered Nedd8-Activating Enzyme (NAE), located upstream of the proteasome in the Ubiquitin Proteasome Pathway (UPP). The discovery of MLN4924 was recently published in the journal Nature in April 2009.

Millennium will continue its research and development activities in protein homeostasis, which has been shown to be linked to the pathologic properties of a broad range of cancers. The advancement of the oral formulation of MLN9708 is the latest example of the Company moving this program forward based on its expertise in this unique area of cancer biology.

Millennium and Harvard Medical School’s Office of Technology Development announced an innovative collaborative agreement in January 2008 to pursue a research program in the area of protein homeostasis. Under the terms of the agreement, Harvard has granted Millennium a license to certain inventions from the laboratory of Professor J. Wade Harper. The two institutions are working jointly to advance the program in this new area of research over several years under a sponsored research agreement.