ImmunoGen, Inc. Announces Encouraging IMGN388 Clinical Data Reported at ASCO

– ImmunoGen anticancer compound shows favorable tolerability and evidence of activity, with dose escalation continuing –

WALTHAM, Mass.--(BUSINESS WIRE)--Jun 7, 2010 - ImmunoGen, Inc. (Nasdaq: IMGN), a biopharmaceutical company that develops targeted anticancer therapeutics, today announced the presentation of the first clinical data for the Company's IMGN388 anticancer compound at the 2010 Annual Meeting of the American Society of Clinical Oncology (ASCO) being held in Chicago, IL. In this dose-escalation trial, IMGN388 has demonstrated favorable tolerability at the dose levels evaluated to date, and evidence of activity is being reported now that higher doses are starting to be evaluated. Dose escalation is continuing.

“We're encouraged by the clinical findings with IMGN388,” commented James O'Leary, MD, Vice President and Chief Medical Officer. “It's been well tolerated at the doses evaluated to date. This has enabled rapid advancement to dose levels where we'd expect to begin seeing evidence of activity and that has started to occur. We're using this trial to inform the next steps in IMGN388's development, which we expect to include its assessment as part of a combination regimen and potentially in specific types of cancer.”

IMGN388

IMGN388 is in development by ImmunoGen for the treatment of solid tumors. It utilizes the Company's Targeted Antibody Payload (TAP) technology and consists of ImmunoGen's DM4 cancer-cell killing agent attached to an αv integrin-targeting antibody using the Company's method of attachment. The antibody component serves to target IMGN388 to αv integrin-expressing cells and the DM4 serves to kill these cells. The compound's integrin target is expressed on a wide variety of solid tumors and also on endothelial cells in the process of forming new blood vessels (angiogenesis), a process that needs to occur in order for solid tumors to grow.

Clinical Data Reported

The data reported today (Abstract #3058) are from the first clinical trial to be conducted with IMGN388. In the dose-escalation phase of this trial, patients with any type of solid tumor are eligible for enrollment. Once the maximum tolerated dose has been established, enrollment will be limited to patients with solid tumors confirmed to express its αv integrin target. To date, doses ranging from 5 to 130 mg/m2 have been evaluated, IMGN388 has been found to be well tolerated, and dose escalation is continuing.

The evidence of activity reported is increasing with escalating dose levels:

 

  • Among patients receiving 5, 10, 20 or 30 mg/m2 – no evidence of activity;
  • Among patients receiving 45 or 60 mg/m2 – one patient at each dose level had stable disease lasting for up to 6 treatment cycles (18 weeks); and
  • Among patients receiving 80 or 105 mg/m2 – four of these six patients had stable disease. This response was ongoing in two patients at the time of the presentation and had been sustained for at least 7 treatment cycles (21 weeks) in one of these patients.

All of the patients treated with 130 mg/m2 were still on study, but had not been followed for sufficient time for inclusion in the efficacy analysis.

The responses to IMGN388 occurred in an array of tumor types – non-small cell lung cancer (two patients) and in prostate, breast, neuroendocrine and uterine cancer. All of these patients had relapsed disease.

About ImmunoGen's Targeted Antibody Payload (TAP) Technology

The Company's TAP technology uses manufactured antibodies to deliver one of ImmunoGen's highly potent cancer-cell killing agents (e.g., DM1, DM4) specifically to tumors. The Company's cancer-cell killing agents are many-fold more potent than standard chemotherapeutics and were developed by ImmunoGen scientists specifically for targeted delivery to tumors. ImmunoGen has also engineered linkage technology that keeps the cancer-cell killing agent attached to the antibody until it reaches the cancer cell and then controls the release of the agent inside the cell. In addition to IMGN388, five other compounds that make use of ImmunoGen's TAP technology are in clinical testing.

About ImmunoGen, Inc.

ImmunoGen, Inc. develops targeted anticancer therapeutics using its expertise in cancer biology, monoclonal antibodies and the creation and attachment of potent cancer-cell killing agents. The Company's TAP technology uses antibodies to deliver one of ImmunoGen's highly potent cancer-cell killing agents specifically to tumors. In addition to the Company's product pipeline, compounds utilizing the TAP technology 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 compound, trastuzumab-DM1 (T-DM1), is in Phase III testing being conducted by Genentech and Roche. Other ImmunoGen collaborative partners include Bayer Schering Pharma and Amgen. More information about ImmunoGen can be found at www.immunogen.com.

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 IMGN388, that include 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.

Contact: For Investors:
ImmunoGen, Inc.
Carol Hausner, 781-895-0600
Executive Director, Investor Relations and Corporate Communications
or
For Media:
The Yates Network
Barbara Yates, 781-258-6153

 

Posted: June 2010

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