Profile: Immunogen Inc (IMGN.O)
6 Dec 2013
ImmunoGen, Inc. (ImmunoGen), incorporated on March 27, 1981, develops targeted, antibody-based therapeutics for the treatment of cancer. ImmunoGen designs linkers that enable antibody-based therapeutics for the treatment of cancer agents to remain stably attached to the antibodies while in the blood stream and be released in their fully active form after delivery to a cancer cell. An anticancer compound made using the Company’s Targeted Antibody Payload (TAP), technology consists of a monoclonal antibody. The Company's TAP technology is designed to enable the creation of well-tolerated anticancer products. As of June 30, 2012, ImmunoGen had three wholly owned clinical-stage product candidates included IMGN901, IMGN853, and IMGN529, and other TAP compounds in earlier stages of development.
IMGN901 is a potential treatment for small-cell lung cancer (SCLC), and other cancers that express CD56 and is in Phase II testing for the first-line treatment of SCLC. IMGN853 is a potential treatment for ovarian cancer, non-small cell lung cancer (NSCLC), and other cancers that over-express the Company’s folate receptor target and began Phase I testing in mid-2012. IMGN529 is a potential treatment for non-Hodgkin's lymphoma (NHL), and chronic lymphocytic leukemia and began Phase I testing in early 2012. It also has earlier stage compounds in development and expects to advance ImmunoGen's next wholly owned compound to Investigational New Drug (IND), application stage in mid-2013. In addition to the COmpany's product programs, it continues to invest in the TAP technology, including the development of additional cytotoxic agents and engineered linkers, to maintain a leadership position in its field.
Trastuzumab emtansine is also known as T-DM1. T-DM1 consists of trastuzumab, which is the active component of Genentech's antibody therapeutic, Herceptin (trastuzumab), with the Company’s DM1 cell-killing agent attached using ImmunoGen's SMCC engineered linker. T-DM1 is in global development by Genentech's parent company, Roche, under a license with the Company. T-DM1 is in Phase III testing for the treatment of HER2+ metastatic breast cancer (mBC). For HER2+ mBC previously treated with Herceptin and with a taxane, Roche's lead T-DM1 Phase III trial, EMILIA, compares T-DM1, used alone, with Tykerb (lapatinib) used together with Xeloda (capecitabine) to treat HER2+ mBC in patients who have previously received Herceptin with a taxane. EMILIA has two co-primary endpoints: progression-free survival (PFS), and overall survival (OS). For first-line treatment of HER2+ mBC, Roche has a Phase III trial, MARIANNE, to assess T-DM1 for first-line treatment of HER2+ mBC. For HER2+ mBC previously treated with Herceptin and with Tykerb, Roche also has a Phase III trial, TH3RESA. During the fiscal year ended June 30, 2012 (fiscal 2012) Roche presented the Company's three-pronged approach to developing T-DM1 for the treatment of HER2+ eBC: development for neoadjuvant use, for adjuvant use, and for patients with residual invasive disease following surgery.
ImmunoGen wholly owned product candidate is the TAP compound lorvotuzumab mertansine, which it also calls IMGN901. The Company developed IMGN901 to target CD56, which is found on SCLC, Merkel cell carcinoma, multiple myeloma, ovarian cancers, carcinoid tumors, and other cancers of neuroendocrine origin. In early clinical testing, IMGN901 demonstrated evidence of activity when used alone to treat CD56+ cancers that had recurred after treatment with approved anticancer drugs. In March 2012, it began Phase II evaluation of IMGN901, used in combination with etoposide/carboplatin (E/C), as a treatment for newly diagnosed metastatic SCLC. IMGN901 is being assessed in a Phase I clinical trial for the treatment of multiple myeloma, used in combination with lenalidomide plus dexamethasone, a standard of care for this cancer.
ImmunoGen's IMGN853 TAP compound targets folate receptor 1 (FOLR1). IMGN853 consists of a FOLR1-targeting antibody with one of the Company's potent cell-killing agents attached using one of the linkers engineered to counteract the multi-drug resistance. In July 2012, it advanced IMGN853 into clinical testing in a Phase I clinical trial.
ImmunoGen's IMGN529 TAP compound targets CD37, which is expressed on B-cell malignancies, such as NHL and chronic lymphocytic leukemia. IMGN529 comprises an antibody that, in preclinical testing, has demonstrated meaningful anticancer activity, the Company's DM1 cell-killing agent, and the SMCC engineered linker, thus paralleling T-DM1 in design. In April 2012, the Company began Phase I clinical testing of IMGN529 for the treatment of NHL.
The Company competes with Pfizer, Seattle Genetics, Roche and Bristol Myers Squibb.
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