– Novel Antibody Therapy for Multiple Hematological Malignancies Enters Clinic –
WALTHAM, Mass.--(BUSINESS WIRE)-- ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that develops targeted antibody-based anticancer products, today announced that sanofi-aventis has initiated a Phase I clinical trial with SAR650984, an investigational antibody that targets cancer cells expressing the CD38 protein antigen. This event triggers a $1 million milestone payment to ImmunoGen.
Developed under a research collaboration between ImmunoGen and sanofi-aventis, SAR650984 is being evaluated as a potential treatment for a number of hematological (blood) tumors, including acute and chronic lymphocytic leukemia, acute and chronic myeloid leukemia, multiple myeloma and non-Hodgkin’s lymphoma.
In preclinical testing, SAR650984 has been found to be an effective anticancer agent. Of particular note, it has been found to have potent antibody-dependent cell-mediated cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), and apoptotic activity (achievement of programmed cell death).1
John Lambert, PhD, Executive Vice President and Chief Scientific Officer, commented, “ImmunoGen has extensive capabilities in the development and evaluation of antibodies – both for use as anticancer agents on their own as ‘naked antibodies’, like SAR650984, and as part of TAP compounds. SAR650984 killed cancer cells through three different mechanisms – ADCC, CDC, and apoptosis – in our preclinical models. We believe this compound may provide unique benefits in the treatment of a number of hematological malignancies.”
SAR650984 is being evaluated in a Phase I, dose-escalation trial to establish its maximum tolerated dose and dose-limiting toxicities. Patients with certain types of relapsed/refractory CD38+ hematological malignancies are eligible for enrollment, including B-cell non-Hodgkin’s lymphoma, multiple myeloma, acute myeloid leukemia, acute lymphoblastic leukemia, and chronic lymphocytic leukemia.
About the Research Collaboration between ImmunoGen and sanofi-aventis
In 2003, ImmunoGen and sanofi-aventis (then Aventis) entered into a five-year research collaboration to develop novel antibody-based anticancer drugs using ImmunoGen’s antibody expertise. These included therapeutic antibody compounds, such as SAR650984, and Targeted Antibody Payload (TAP) compounds, in which the antibody is conjugated to one of ImmunoGen’s proprietary highly potent cancer-cell killing agents. For each compound, ImmunoGen is entitled to receive milestone payments plus royalties on the sales of any resulting product; ImmunoGen also has certain co-promotion rights. Sanofi-aventis is responsible for product development, clinical testing, manufacturing and marketing.
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 TAP technology uses antibodies to deliver one of ImmunoGen’s proprietary cancer-cell killing agents specifically to tumor targets. In addition to the Company’s product pipeline, compounds are in clinical testing through ImmunoGen’s collaborations with Genentech (a wholly owned member of the Roche Group), sanofi-aventis, Biogen Idec and Biotest. The most advanced TAP compound, trastuzumab-DM1 (T-DM1), is in Phase III testing being conducted by Genentech and Roche. Other ImmunoGen collaborative partners include Bayer HealthCare and Amgen. More information about ImmunoGen can be found at www.immunogen.com.
1Park P et al, SAR650984: A Potent Anti-CD38 Therapeutic Antibody with Three Mechanisms of Action (Apoptosis, ADCC, CDC) for Hematological Malignancies (abstract # 2756), 50th ASH Annual Meeting and Exposition, 2008.
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 novel anticancer products, including SAR650984, 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, 2009 and other reports filed with the Securities and Exchange Commission.
Carol Hausner, 781-895-0600
Executive Director, Investor Relations and Corporate Communications
The Yates Network
Adriana Jenkins, 617-744-1713
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INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Pharmaceutical General Health