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Profile: ImmunoGen Inc (IMGN.OQ)

IMGN.OQ on NASDAQ Stock Exchange Global Select Market

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29 Apr 2016
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ImmunoGen, Inc. (ImmunoGen), incorporated on March 27, 1981, is a clinical-stage biotechnology company focused on the development of targeted anticancer therapeutics. The Company's clinical and preclinical product candidates are antibody-drug conjugates (ADCs), which is a type of medicine that uses a monoclonal antibody to deliver a therapeutic agent to targeted cells. The Company's ADC technology enables the creation of well-tolerated anticancer products. An ADC with its technology comprises an antibody that binds specifically to an antigen target found on the surface of cancer cells with one of its potent cancer-cell killing, or payload, agents attached to the antibody using one of the engineered linkers. The Company has tubulin-acting payload agents, such as DM1 and DM4, which are maytansinoids, and, deoxyribonucleic acid (DNA)-alkylating payload agents, such as DGN462, which is called IGNs. The Company's linkers are engineered to keep its cell-killing agents attached to the antibody while traveling through the bloodstream and then control its release and activation once inside a cancer cell.

The Company develops its own product candidates using the ADC technology and licenses to other companies' limited rights to use the ADC technology with their antibodies to create products. The Company has three clinical-stage anticancer compounds: mirvetuximab soravtansine (IMGN853), coltuximab ravtansine, IMGN529 and IMGN779. The Company's partners are Amgen Inc., Bayer HealthCare (a subgroup of Bayer AG), Biotest AG, Eli Lilly and Company (Lilly), Novartis Institutes for BioMedical Research, Inc. (Novartis), the Roche Group, Sanofi and Takeda. The Company also has a research agreement with CytomX Therapeutics that allows each company to develop probody-drug conjugates against a specified number of antigen targets using CytomX's Probody antibody-masking technology with its payload agents and engineered linkers. The Company's collaborative partner compounds include Kadcyla, Indatuximab ravtansine, Isatuximab, Anetumumab ravtansine, AMG 595, AMG 172, SAR566658, SAR408701, LOP628 and PCA062. All of the Company's compounds are ADCs with the exception of isatuximab, which is a therapeutic antibody. All of the Company's compounds are in early clinical testing (Phase I and/or Phase II) with the exception of Kadcyla, which is marketed, and IMGN779, which is in preclinical testing.

Wholly Owned Compounds

The Company's product candidate IMGN853 is a folate receptor alpha (a) (Fra)-targeting ADC that is a potential treatment for ovarian cancer and certain other FRa-positive solid tumors. This ADC comprises a FRa-binding antibody with its potent DM4 cell-killing agent attached using one of its engineered linkers. The Company is also assessing mirvetuximab soravtansine in the ongoing Phase I trial as a single-agent treatment for relapsed/refractory FRa-positive endometrial cancer, with other FRa-positive uses being assessed preclinically. IMGN529 and coltuximab ravtansine are potential treatments for diffuse large B-cell lymphoma (DLBCL) and other B-cell malignancies. IMGN529 includes an ImmunoGen CD37-targeting antibody that, in preclinical testing, demonstrated anticancer activity. DM1 is attached to it using one of its engineered linkers. The Company is planning to start clinical testing of IMGN529 in combination with rituximab in patients with DLBCL. Coltuximab ravtansine is a CD19-targeting ADC that is a potential new treatment for DLBCL. The Company plans to initiate clinical testing of coltuximab ravtansine used in a combination regimen or regimens for DLBCL. IMGN779 is a potential treatment for acute myeloid leukemia and myelodysplastic syndrome. It comprises an ImmunoGen CD33-targeting antibody with one of its DNA-acting payload agents, DGN462, attached using one of its engineered linkers. The Company intends to submit an Investigational New Drug (IND) application for IMGN779.

Compounds in Development by Partners

The compound with the Company's ADC technology is Roche's marketed product, Kadcyla (ado-trastuzumab emtansine). Eight earlier-stage ADCs and one therapeutic antibody are in development through the Company's collaborations. The Company has opt-in rights for co-development and co-commercialization of indatuximab ravtansine, or BT-062, jointly with Biotest in the United States. Kadcyla is a HER2-targeting ADC that consists of Roche's trastuzumab antibody with its DM1 cell-killing agent attached using one of its engineered linkers. Roche is developing Kadcyla for a number of additional HER2-positive solid tumors, including stomach cancer, early breast cancer and lung cancer. BT-062 is a CD138-targeting ADC created by Biotest under a license from ImmunoGen. The Company has opt-in rights for co-development and co-commercialization of indatuximab ravtansine with Biotest in the United States. The target for indatuximab ravtansine also has been found to occur on various types of solid tumors.

The Company's partners are in development of a number of compounds in both solid tumors and hematological malignancies, which include Anetumumab ravtansine, also referred to as BAY 94-9343, Isatuximab, also referred to as SAR650984, AMG 595 and SAR566658. BAY 94-9343 is a mesothelin-targeting ADC created by Bayer under a license from ImmunoGen. BAY 94-9343 is being assessed for the treatment of mesothelioma and of ovarian cancer in early clinical trials. SAR650984 is a CD38-targeting therapeutic, or naked, antibody initially created by ImmunoGen and licensed to Sanofi as part of a research collaboration. SAR650984 has shown activity in early clinical testing when used alone and as part of a combination regimen to treat patients with treated multiple myeloma. Sanofi began Phase II testing of SAR650984 for multiple myeloma. AMG 595 is an EGFRvIII-targeting ADC created by Amgen under a license from ImmunoGen. AMG 595 is in Phase I clinical testing for the treatment of patients with glioblastoma. SAR566658 is a CA6-targeting ADC created by ImmunoGen and licensed to Sanofi as part of a research collaboration. SAR566658 is in Phase I clinical testing for the treatment of CA6-positive solid tumors, such as ovarian cancer.

The Company' various partners is in development of products for clinical testing include AMG 172, SAR408701 and LOP628 and PCA062. AMG 172 is a CD70-targeting ADC created by Amgen under a license from ImmunoGen. AMG 172 is in Phase1 clinical testing for the treatment of patients with clear cell renal cell carcinoma. SAR408701 is a CEACAM5-targeting ADC created by ImmunoGen and licensed to Sanofi as part of a research collaboration. SAR408701 entered Phase I clinical testing in 2014. LOP628 and PCA062 are ADCs created by Novartis under licenses from ImmunoGen and entered Phase I clinical testing in 2015. LOP628 targets c-Kit-positive cancers and PCA062 targets p-cadherin-positive cancers. The earlier-stage preclinical compounds in development by the Company and its partners, including Amgen, Novartis, Lilly, Sanofi, Takeda and CytomX.

The Company competes with Pfizer, Seattle Genetics, Roche, Bristol-Myers Squibb and Takeda.

Company Address

ImmunoGen Inc

830 WINTER ST
WALTHAM   MA   02451-1477
P: +1781.8950600
F: +1781.8950611

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