Millennium, The Takeda Oncology Company announced the initiation of a phase-1 trial series of MLN4924, the company's first-in-class, small molecule inhibitor of the Millennium-discovered target, the Nedd 8 Activating Enzyme (NAE). MLN4924 advanced to the clinic with the first patient dosed in April 2008. The two phase-1 dose escalation studies aim to assess safety, tolerability, pharmacokinetic and pharmacodynamic effects in patients with advanced solid tumours or with haematological malignancies.
In addition, the company initiated a phase-1 rheumatologic trial of MLN8237, the first-in-class, specific Aurora A kinase inhibitor based on emerging pre-clinical data on the role of Aurora A in lymphomas and other rheumatologic tumours. Pre-clinical results also showed substantial activity in paediatric neuroblastoma and acute lymphocytic leukaemia (ALL). Additional data related to the Aurora A kinase development programme are scheduled to be presented at the 20th EORTC-NCI-AACR Symposium in Geneva, Switzerland in October, 2008. Millennium plans to expand the program into Phase II trials in late 2008/early 2009.
"The progress of these two Millennium-discovered oncology drugs is important to our goal of bringing innovative medicines to cancer patients," said Nancy Simonian, MD, chief medical officer, Millennium. "The emerging data associated with MLN4924 and MLN8237 support our vision of solidifying Takeda as a leader in oncology discovery and development by 2020," Nancy said.
MLN4924 targets NAE, a novel, Millennium-discovered target in the ubiquitin proteasome pathway (UPP). NAE controls a subset of proteins in the UPP that regulate cancer cell survival. MLN8237 is a second-generation small molecule backup of MLN8054, the company's first Aurora A kinase inhibitor. Both molecules were discovered and developed by scientists at Millennium for the treatment of cancer.
Millennium: The Takeda Oncology Company, and a leading biopharmaceutical company based in Cambridge, Massachusetts, markets Velcade, a novel cancer product, and has a robust clinical development pipeline of product candidates.