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ImmunoGen's stock surges on breast cancer data...
Boston Business Journal - by Julie M. Donnelly
Date: Thursday, April 7, 2011, 2:32pm EDT


ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company focused on developing cancer drugs, saw its stock climb 22 percent on news that its potential therapy for breast cancer achieved positive phase 2 trial results. The results showed that that this new experimental therapy could potentially be more effective than a combination of Herceptin and chemotherapy, which is the current standard of care for many HER2-positive breast cancer patients.


The Waltham, Mass.-based biotech's partner, Swiss drug maker Roche AG (Swiss: RO.SW ), said that T-DM1, a combination of a cancer cell-killing agent developed by Immunogen and Herceptin, developed by Cal.-based Genentech, now owned by Roche, showed a significant improvement in progression-free survival, over the combination of Herceptin plus chemotherapy.

"This top-line information about T-DM1's performance in the first-line setting is very encouraging and adds to the favorable efficacy and safety data reported across a number of T-DM1 studies. We look forward to learning the detailed data when they are reported at a medical conference," ImmunoGen CEO Daniel Junius said in a statement.

Immunogen's stock was trading at $11.42 Thursday afternoon, up from $9.30 at the previous close.

Biotech Stocks: XenoPort, ImmunoGen shine in drug-stock trading...
ImmunoGen shares rise on positive study results
AP(Thu, Apr 7)


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IMGN  T-DM1 Significantly Improved Progression-Free Survival... 
by Business Wire  Apr 7 2011 6:00AM

WALTHAM, Mass., Apr 07, 2011 (BUSINESS WIRE) -- ImmunoGen, Inc. (IMGN), a biotechnology company that develops targeted antibody-based anticancer products, today announced that Roche has disclosed positive top-line results from the first randomized trial assessing trastuzumab emtansine (T-DM1, previously known as trastuzumab-DM1) in HER2-positive metastatic breast cancer (MBC). T-DM1 consists of ImmunoGen's DM1 cancer cell-killing agent attached using the Company's linker to the HER2-targeting antibody, trastuzumab, developed by Genentech, a member of the Roche Group.

The top-line results disclosed by Roche in a press release today were that patients treated with T-DM1 had a significant improvement in progression-free survival compared with patients treated with Herceptin(R) (trastuzumab) plus chemotherapy (docetaxel) in the Phase II trial comparing these agents for first-line treatment for HER2-positive MBC.

The detailed findings from this randomized, 137-patient trial are being submitted for presentation at a future medical conference. Favorable preliminary data were reported previously from this trial at the 35th Congress of the European Society of Medical Oncology (ESMO), but progression-free survival data were not available at that time.(1)

"This top-line information about T-DM1's performance in the first-line setting is very encouraging and adds to the favorable efficacy and safety data reported across a number of T-DM1 studies. We look forward to learning the detailed data when they are reported at a medical conference," said Daniel Junius, President and CEO.

About Trastuzumab Emtansine (T-DM1)

Trastuzumab emtansine (the generic or International Non-proprietary Name for T-DM1) utilizes ImmunoGen's Targeted Antibody Payload (TAP) technology with the trastuzumab antibody developed by Genentech. The compound is in global development by Roche under a collaboration agreement between ImmunoGen and Genentech.

T-DM1 is in Phase III testing for second-line and first-line treatment of HER2-positive MBC. A Phase II trial evaluating the safety of T-DM1 in the neoadjuvant/adjuvant setting began in late 2010.

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 currently seven TAP compounds in the clinic, with a wealth of clinical data reported with the technology. ImmunoGen's collaborative partners include Amgen, Bayer Schering Pharma, Biogen Idec, Biotest, Genentech (a member of the Roche Group), Novartis, and sanofi-aventis. 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. More information about ImmunoGen can be found at www.immunogen.com .

References

(1)Perez E. et al., ESMO 2010, Abstract LBA3

Herceptin(R) is a registered trademark of Genentech.

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 trastuzumab emtansine (T-DM1), including risks related to uncertainties around clinical studies and data acceptance for presentation, as well as 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, 2010 and other reports filed with the Securities and Exchange Commission.

SOURCE: ImmunoGen, Inc.


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

Encouraging Data on Roche's Drug...

Roche Holdings Ltd. (Other OTC: RHHBY.PK - News) recently announced positive data from a mid-stage trial of trastuzumab emtansine (T-DM1) in patients with HER2-positive metastatic breast cancer. The phase II trial (TDM4450g) was conducted to compare T-DM1 with the combination of Herceptin (trastuzumab) and chemotherapy (docetaxel) in treatment naïve patients.

The trial results demonstrated that patients treated with T-DM1 achieved higher progression free survival (the primary endpoint of the study) and experienced fewer of the side effects associated primarily with chemotherapy.

In August last year, the US Food and Drug Administration (FDA) refused to accept the Roche's Biologics License Application (BLA) seeking accelerated approval for T-DM1 as a treatment for breast cancer.

The BLA was submitted by Roche in July 2010 on the basis of mid-stage trial results. The data demonstrated that the candidate reduced the size of tumors in a third of women with advanced HER2-positive breast cancer. On an average, these women had received seven treatments earlier.

The regulatory body did not accept the BLA because it believed that the patients in the phase II study had not tried all possible medications available for the treatment of metastatic breast cancer.

Roche is currently conducting a late-stage trial (EMILIA) with the candidate. The study is comparing T-DM1 with GlaxoSmithKline plc's (NYSE: GSK - News) lapatinib (Tykerb), which is administered in combination with capecitabine (Xeloda). The study is being conducted in women with advanced HER2-positive breast cancer, whose disease worsened after initial treatment.

Roche has an agreement with ImmunoGen Inc. (NasdaqGS: IMGN - News) for the global development of T-DM1 and the companies plan to file a new BLA with the FDA in mid 2012, which will be supported by the phase III (EMILIA) study results.