ImmunoGen, Inc . (Nasdaq: IMGN), a biotechnology company that develops anticancer therapeutics using its antibody expertise and Targeted Antibody Payload (TAP) technology, today announced the start of clinical testing with its IMGN853 product candidate. The Phase I trial initiated evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics and anticancer activity of this TAP compound in patients with ovarian cancer or other solid tumors that over-express FOLR1 (also known as folate receptor alpha), including non-small cell lung cancer (NSCLC). Once the maximum tolerated dose (MTD) of IMGN853 is established, the activity of the compound will be evaluated in disease-specific patient cohorts. “This trial is expected to provide key information needed to define the registration path for IMGN853,” commented James O’Leary, MD, Vice President and Chief Medical Officer. “The study protocol allows for the use of single-patient cohorts for evaluation of the lower dose levels, which should accelerate the pace of advancement to higher doses and to the trial’s expansion phase. In the expansion phase, IMGN853 will be evaluated as a treatment for specific types of FOLR1-overexpressing tumors. These findings should enable us to make decisions needed to advance IMGN853 into later-stage clinical testing.” About the Phase I Trial Initiated This multi-center, first-in-human US Phase I trial is designed to enroll approximately 64 patients with previously treated ovarian cancer, NSCLC or other epithelial malignancies that over-express FOLR1. Once the MTD is defined in the dose-escalation part of the trial, three expansion cohorts will be opened to evaluate the pharmacodynamics and antitumor activity of IMGN853 at this MTD in patients with specific types of cancers:
- Epithelial ovarian cancer (EOC) that is refractory/resistant to platinum;
- EOC that is relapsed/refractory to conventional treatments;
- Adenocarcinoma NSCLC that is relapsed/refractory to conventional treatments.
About ImmunoGen, Inc.ImmunoGen, Inc. develops targeted anticancer therapeutics using the Company's expertise in tumor biology, monoclonal antibodies, potent cancer-cell killing agents and engineered linkers. The Company's TAP technology uses monoclonal antibodies to deliver one of ImmunoGen's proprietary cancer-cell killing agents specifically to tumor cells. There are now numerous TAP compounds in clinical development with a wealth of clinical data reported. ImmunoGen’s collaborative partners include Amgen, Bayer HealthCare Pharmaceuticals, Biotest, Lilly, Novartis, Roche, and Sanofi. The most advanced compound using ImmunoGen's TAP technology, trastuzumab emtansine (T-DM1), is in Phase III testing through the Company's collaboration with Genentech, a member of the Roche Group. More information about ImmunoGen can be found at www.immunogen.com. 1American Cancer Society (2012), Cancer Facts & Figures. 2 American Cancer Society (2012), Lung Cancer (Non-Small Cell) Detailed Guide. 3 American Cancer Society (2012), Ovarian Cancer Detailed Guide. 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 IMGN853, including risks related to preclinical and clinical studies, 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, 2011 and other reports filed with the Securities and Exchange Commission.