News

January 15, 2003
ImmunoGen, Inc. Announces Publication of Cantuzumab Mertansine Phase I Study in the Journal of Clinical Oncology

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan. 15, 2003--ImmunoGen, Inc. (Nasdaq: IMGN) today announced the publication of Phase I study results with cantuzumab mertansine (huC242-DM1/SB-408075) in the Journal of Clinical Oncology. The report includes clinical findings related to the product candidate's safety, pharmacokinetics, and activity. It also presents evidence, from tumor biopsy, of localization of cantuzumab mertansine in cancerous tissue.

"Cantuzumab Mertansine, a Maytansinoid Immunoconjugate Directed to the CanAg Antigen: A Phase I, Pharmacokinetic and Biologic Correlative Study" by Anthony W. Tolcher et al. reports the findings of a Phase I study in which cantuzumab mertansine is administered once every three weeks to patients with refractory cancer that expresses the CanAg antigen targeted by the product. Most of the patients in the study had colon cancer, but patients with pancreatic cancer and non-small-cell lung cancer were also enrolled. In this dose-escalation study, dosing was started at low levels (22 mg/m2) and increased in each new cohort of patients enrolled until dose-limiting toxicity was observed.

The authors reported that the recommended dose for cantuzumab mertansine is 235 mg/m2 when the product is administered once every three weeks. They conclude that "the absence of severe hematologic toxic effects, preliminary evidence of cantuzumab mertansine tumor localization, and encouraging biologic activity in chemotherapy-refractory patients warrant further broad clinical development of this immunoconjugate in CanAg-expressing tumors."

The publication includes biopsy findings from one colon cancer patient who had accessible metastases under the skin. The patient consented to having a biopsy of this cancerous tissue done 24 hours after administration of cantuzumab mertansine. Immunohistochemical staining of the cancerous tissue using anti-DM1 antibody indicated DM1 localization at the tumor site. This patient had a reduction in lung metastases after two and four courses of cantuzumab mertansine, and received a total of six courses.

Mitchel Sayare, Ph.D., ImmunoGen Chairman and CEO, commented, "We are very pleased that the complete data from this Phase I study with cantuzumab mertansine have been made available to the oncology community through its publication by Dr. Tolcher et al. in the Journal of Clinical Oncology. As noted in the publication, these findings support further study of cantuzumab mertansine."

Cantuzumab mertansine is a Tumor-Activated Prodrug (TAP) compound developed by ImmunoGen. It is composed of the humanized antibody huC242 and the cytotoxic agent DM1. The huC242 antibody binds specifically to the CanAg antigen present in a number of cancers including colorectal, pancreatic, and gastric cancers as well as certain non-small-cell lung cancers. Cantuzumab mertansine is designed to deliver the highly potent cell-killing agent DM1 specifically to cancer cells using the huC242 antibody as a targeting vehicle.

In early 1999, the Company licensed development and commercialization rights for cantuzumab mertansine to SmithKline Beecham, which later became GlaxoSmithKline. The two companies are currently in negotiations regarding this agreement.

About ImmunoGen, Inc.

ImmunoGen, Inc. develops targeted anticancer biopharmaceuticals. The Company's TAP technology uses tumor-targeting antibodies to deliver a highly potent, cell-killing agent specifically to cancer cells. Two ImmunoGen-developed TAP products have begun clinical testing: cantuzumab mertansine, which is licensed to GlaxoSmithKline, and huN901-DM1 (BB-10901), which is licensed to British Biotech in certain territories. ImmunoGen helps fund its programs by licensing its TAP technology to other companies. Several companies are developing TAP products that use ImmunoGen's TAP technology with the partner's antibody: Boehringer Ingelheim (bivatuzumab mertansine), Millennium (MLN2704), and Genentech (Trastuzumab-DM1). ImmunoGen also has multitarget agreements with Genentech, Abgenix, and Millennium.

This press release includes forward-looking statements based on management's current expectations. 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. Various factors could cause the Company's actual results to differ materially from those discussed or implied in the forward-looking statements and you are cautioned not to place undue reliance on these forward-looking statements, which are current only as of the date of this release. Factors that could cause future results to differ materially from such expectations include, but are not limited to: the success of the Company's research and clinical development processes; the difficulties inherent in the development of pharmaceuticals, including uncertainties as to the timing, expense and results of preclinical studies and clinical trials; the Company's dependence upon existing and potential collaborative partners; uncertainty as to whether the Company's potential products or those of the Company's collaborators will succeed in entering human clinical trials and uncertainty as to the results of such trials; the risk that the Company and/or its collaborators may not be able to obtain regulatory approvals necessary to commercialize their product candidates; the potential development by competitors of competing products and technologies; uncertainty whether the Company's TAP technology will produce safe, effective and commercially viable products; and other factors more fully described in ImmunoGen's Annual Report on Form 10-K for the fiscal year ended June 30, 2002 and other current reports filed with the Securities and Exchange Commission. 

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