Why it is profiled?Watch out for potential upcoming catalysts
Biotechnology company ImmunoGen Inc.(IMGN)develops targeted anticancer therapeutics using its Targeted Antibody Payload technology. In addition to developing its own product candidates, the company also selectively outlicenses its technology to other companies for use with their engineered antibodies.
The TAP (Targeted Antibody Payload) technology is designed to achieve more effective, better tolerated anticancer drugs, In other words, a TAP compound is designed to kill cancer cells while minimizing damage to healthy tissue.
Sanofi-Aventis (SNY), Genentech - owned by Swiss pharmaceutical giant Roche, Bayer Healthcare, Biogen Idec Inc. (BIIB) and Amgen Inc. (AMGN) are some of ImmunoGen's collaborative partners that use its TAP technology.
There are a number of TAP compounds under development by ImmunoGen as well as by its partners. The most advanced compound is Trastuzumab-DM1, or T-DM1, which is being developed by Roche.
Roche is planning to submit a marketing application to the FDA this year for use of Trastuzumab-DM1, seeking accelerated approval of the drug as a 3rd-line treatment of HER2-positive metastatic breast cancer, based on phase II results.
In the phase II study, T-DM1 shrank the tumors in 33% of women with advanced (metastatic) HER2-positive breast cancer that had worsened following previous treatment. The study enrolled women who had already received an average of seven drugs for metastatic disease, including chemotherapy, Herceptin (trastuzumab) and Tykerb (lapatinib), prior to receiving T-DM1.
The other clinical trials that are underway with T-DM1 include:
- A phase III clinical trial dubbed EMILIA that compares single agent T-DM1 to Tykerb plus Xeloda as second-line therapy for HER2-positive metastatic breast cancer. This trial, which was commenced in February 2009, is designed to enroll 580 patients, and its primary endpoint is progression-free survival. Roche is expected to provide information related to this trial during this year, such as an update on the status of patient enrollment.
- A phase II trial assessing T-DM1 as a first-line therapy for HER2-positive metastatic breast cancer that compares single-agent T-DM1 to Trastuzumab plus Docetaxel (Taxotere). The trial has completed patient enrollment and its primary endpoint is progression-free survival. The preliminary data from this trial is expected to be presented at the European Society for Medical Oncology, or ESMO, annual meeting in October 2010 and
- A phase Ib/II clinical trial assessing the tolerability of T-DM1 used in combination with Pertuzumab. Findings from this trial have been accepted to be reported at the American Society of Clinical Oncology, or ASCO, meeting next month.
In addition to the above, Roche is expected to commence a phase III clinical trial to assess T-DM1 as a first-line treatment for HER2-positive metastatic breast cancer in the second half of 2010 and will have progression-free survival as a primary endpoint. This trial will compare single agent T-DM1 to T-DM1 plus Pertuzumab and to Trastuzumab used together with a taxane.
According to Roche, T-DM1 has the potential to garner peak sales of anywhere from 2 billion to 5 billion Swiss Francs.
The other advanced drugs in the pipeline include SAR3419 for non-Hodgkin's lymphoma and Lorvotuzumab mertansine for the treatment of solid tumors and multiple myeloma.
Lorvotuzumab is wholly owned by ImmunoGen while SAR3419 has been licensed to Sanofi-Aventis. Both Lorvotuzumab and SAR3419 are under phase I development. During the second half of 2010, Sanofi-Aventis expects to begin phase II testing with SAR3419, and ImmunoGen plans to initiate a randomized trial assessing Lorvotuzumab mertansine compound for the treatment of small-cell lung cancer.
IMGN388, BT-062 and BIIB015 are some of the other compounds under phase I development for solid tumors. The first IMGN388 clinical data are expected to be reported at the ASCO next month.
The company's fiscal year ends June 30. For fiscal year ending June 30, 2010, ImmunoGen expects net loss to range between $53 million and 56 million and capital expenditures to be between $1 million and 2 million. The company generates revenue from license and milestone fees.
At March 30, 2010, ImmunoGen had zero debt and total cash of $42.2 million.
Last week, ImmunoGen priced a public offering of 9 million shares of its common stock and about 1.35 million shares to underwriters at a price of $8.00 per share. Net proceeds, after underwriting discounts and commissions and estimated expenses, will be about $77.6 million, according to the company. The offering is expected to close on or about May 12, 2010.
IMGN has thus far hit a 52-week low of $6.25 and high of $10.90. The stock closed Monday's trading session at $8.59 on a volume of 1.17 million shares.
Other stocks "in the spotlight"
For comments and feedback contact: editorial@rttnews.com
May 01, 2026 15:54 ET Central banks dominated the economics news flow this week with almost all major ones announcing their latest policy decisions and many boosted expectations for a rate hike in June. In other news, several countries released the preliminary data for first quarter economic growth. In the U.S., comments by Fed Chair Jerome Powell were also in focus as his term ends this month.