Millennium Presents New Data on Investigational Drugs for Novel Cancer Targets at EORTC-NCI-AACR Symposium

Thursday, October 23, 2008 General News
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CAMBRIDGE, Mass., Oct. 22 Millennium: The Takeda OncologyCompany today announced new data from early non-clinical studies ofMillennium/Takeda-discovered pipeline molecules highlighting novel therapeuticpathways in oncology. MLN4924 data build on the growing body of evidencesupporting the importance of the Millennium-discovered Nedd8 Activating Enzyme(NAE) in tumor growth and survival. It is a first-in-class small moleculeinhibitor of NAE. Both clinical and non-clinical studies of MLN8237 confirmthe importance of inhibiting Aurora A kinase, which is required for cells toproceed through cell division.

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TAK-285 and TAK-593 are receptor tyrosine kinase inhibitors. Non-clinicaldata suggest their efficacy in affecting the Epidermal Growth Factor Receptor/ Human Epidermal Growth Factor Receptor (EGFR/HER) and Vascular EndothelialGrowth Factor/Platelet Derived Growth Factor (VEGF/PDGF) pathways,respectively. The data from 21 Millennium abstracts were presented at the 20thEORTC-NCI-AACR* Symposium on "Molecular Targets and Cancer Therapeutics" heldOctober 21 to 24 in Geneva, Switzerland.

"These new data demonstrate the potential of novel pathways and innovativeapproaches to existing pathways that will further oncology research," saidNancy Simonian, M.D., Chief Medical Officer, Millennium. "Early results suchas these demonstrate our oncology expertise in advancing both the currentMillennium oncology molecules and those we are integrating into our pipelinefrom Takeda."


MLN4924 is a first-in-class small molecule inhibitor of NAE, a new targetdiscovered by Millennium scientists. Data from two non-clinical studiesshowcased at EORTC highlight its potent activity in inducing apoptosis, orprogrammed cell death, in cultured human tumor cells and human tumors grown inmice.

MLN4924 advanced to clinical trials with the first patient dosed in April2008. The two Phase I dose escalation studies aim to assess safety,tolerability, pharmacokinetic and pharmacodynamic effects in patients withadvanced solid tumors or with hematological malignancies.


This Millennium-discovered Aurora A kinase inhibitor currently is beingstudied in Phase I trials in adults both in the United States and Spain.Millennium plans to expand the MLN8237 program into Phase II trials in late2008/early 2009.

Researchers also are investigating MLN8237 as a potential oralsingle-agent therapy for children with either relapsed acute lymphoblasticleukemia (ALL) or advanced neuroblastoma-two pediatric cancers that aredifficult to treat. In October 2008, the first pediatric patient was dosedwith MLN8237 in a clinical trial conducted by the Children's Oncology Group(COG).

New MLN8237 clinical data about safety, dosing, pharmacokinetic andpharmacodynamic results in adults, along with preclinical data about activityin tumor models of pediatric malignancies, were presented at EORTC.


TAK-285 is a novel EGFR/HER dual kinase inhibitor that is being studied inPhase I trials in adults both in the United States and Japan. New TAK-285non-clinical data presented at EORTC suggest good target specificity,favorable pharmacokinetics and tumor distribution, efficacy in EGFR- andHER2-expressing xenograft models, activity in tumors harboring activated RASor inactivated LKB1 mutations and activation of AMPK pathways in cardiac cells.


TAK-593 is a novel small molecule selective inhibitor of the tyrosinekinases for the VEGF and PDGF receptor families. New non-clinical TAK-593data presented at EORTC show potent pseudo-irreversibility against VEGF2 andPDGFbeta.

About Millennium

Millennium: The Takeda Oncology Company, a leading biopharmaceuticalcompany based in Cambridge, Mass., markets VELCADE, a novel cancer product,and has a robust clinical development pipeline of product candidates.Millennium was acquired by Takeda Pharmaceutical Company Ltd in May, 2008. TheCompany's research, development and commercialization activities are focusedin oncology. Additional information about Millennium is available through itswebsite, Pharmacodynamic and efficacy relationship of MLN4924, a novel small molecule inhibitor of Nedd8-activating enzyme, in human xenograft tumors grown in immunocompromised mice -- Lead investigator: Allison Berger, Senior Scientist, Millennium -- Abstract #85: Poster -- MLN4924, a potent and novel small molecule inhibitor of Nedd8 activating enzyme, induces DNA re-replication and apoptosis in cultured human tumor cells -- Lead investigator: Michael Millhollen, Scientist, Millennium -- Abstract #356: Poster

SOURCE Millennium: The Takeda Oncology Company

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