ImmunoGen, Inc. Earns Milestone Payment with Genentech's Start of Trastuzumab-DM1 (T-DM1) Phase III Clinical Testing; Other T-DM1 Progress Reported
WALTHAM, Mass. --(BUSINESS WIRE)--Mar. 2, 2009-- ImmunoGen, Inc. (Nasdaq: IMGN), a biopharmaceutical company that develops targeted anticancer therapeutics, today announced several favorable developments related to T-DM1. T-DM1 comprises ImmunoGen’s DM1 cell-killing agent linked to Genentech’s anti-HER2 antibody, trastuzumab, and is in development by Genentech (US) and Roche (ex-US).
Update on Phase III Evaluation of T-DM1 as a 2nd-Line Treatment for HER2+ MBC
Patient dosing has begun in a Genentech/Roche Phase III trial evaluating T-DM1 as a second-line treatment for HER2-positive metastatic breast cancer (MBC). This event triggers a $6.5 million milestone payment to ImmunoGen. The 580-patient randomized EMILIA trial compares T-DM1, used as a single agent, to capecitabine plus lapatinib, and is anticipated to include approximately 260 clinical centers on a global basis.
Update on Phase II Evaluation of T-DM1 as a 3rd-Line Treatment for HER2+ MBC
Genentech disclosed today that patient enrollment is progressing ahead of schedule in the Phase II trial assessing T-DM1 as a third-line treatment for HER2-positive MBC. Genentech expects patient enrollment to be completed during the first quarter of 2009, and final data from this study to be available in the first quarter of 2010. Genentech has stated that, if the data from this study are compelling, it will discuss an earlier approval path with the US Food and Drug Administration (FDA).
T-DM1: Potential Evaluation for Adjuvant Use
Genentech disclosed today that it is now considering conducting trials to evaluate T-DM1 as an adjuvant treatment for HER2-positive breast cancer.
“T-DM1 is being developed with a rapid and broad strategy,” commented Daniel Junius, President and Chief Executive Officer. “We believe the updates announced today are exciting news not only for ImmunoGen, but -- more importantly -- potentially also for patients with HER2-positive breast cancer.”
About ImmunoGen, Inc.
ImmunoGen, Inc. develops targeted anticancer therapeutics using its expertise in cancer biology, monoclonal antibodies and the creation and attachment of potent cell-killing agents. The Company’s Tumor-Activated Prodrug (TAP) technology uses antibodies to deliver one of ImmunoGen’s proprietary cell-killing agents specifically to cancer targets. In addition to the Company’s proprietary clinical pipeline, ImmunoGen collaborators Genentech, sanofi-aventis, Biogen Idec, and Biotest also are testing TAP compounds in the clinic, and the naked antibody AVE1642 is in clinical trials through the Company’s collaboration with sanofi-aventis. The most advanced TAP compound, trastuzumab-DM1 (T-DM1), is in Phase III testing through the Company’s collaboration with Genentech. Other ImmunoGen collaborative partners include Bayer HealthCare and Amgen.
This press release includes forward-looking statements. For these statements, ImmunoGen claims the protection of the safe harbor for forward-looking statements provided by the Private Securities Litigation Reform Act of 1995. It should be noted that there are risks and uncertainties related to the development of products, including trastuzumab-DM1, by our collaborators, including risks related to uncertainties around clinical trials conducted and their timings and results. A review of these risks can be found in ImmunoGen's Annual Report on Form 10-K for the fiscal year ended June 30, 2008, and other reports filed with the Securities and Exchange Commission.
Source: ImmunoGen, Inc.
ImmunoGen, Inc.
Carol Hausner, 781-895-0600
Executive Director, Investor Relations and Corporate Communications
info@immunogen.com
