There has been a significant change in the treatment of cancer over the years as targeted and more effective, better tolerated anticancer drugs are being developed. Antibody drugs for cancer treatment work by binding specifically to targets found on cancer cells. One of the strategies to maximize the efficacy of antibodies against cancer cells is Targeted Antibody Payload, or TAP, technology developed by biotechnology company ImmunoGen Inc. (IMGN).
Before we take a look at this Waltham, Massachusetts-based company, here's a brief summary of what TAP technology means...
Even though antibodies can effectively target cancer cells, most antibodies are unable to effectively kill cancer cells. This is where ImmunoGen's TAP technology, comprising of highly potent cancer-cell killing agents has a role to play. In other words, a TAP compound is designed to kill cancer cells while minimizing damage to healthy tissue.
ImmunoGen has a pipeline of its own anticancer product candidates developed using its proprietary TAP technology in conjunction with its in-house antibody expertise. ImmunoGen also has collaborative agreements that enable companies to use its TAP technology to develop commercial product candidates to specified targets. Sanofi-Aventis (SNY), Genentech - owned by Swiss pharmaceutical giant Roche , Bayer Healthcare, Biogen Idec Inc. (BIIB) Amgen Inc. (AMGN) Novartis AG (NVS) and Biotest AG are ImmunoGen's collaborative partners that use its TAP technology.
The most advanced TAP compound in clinical testing is Trastuzumab-DM1, or T-DM1, which is in global development by Roche, under a collaboration agreement between ImmunoGen and Genentech.
The clinical trials that are underway with T-DM1 include :
- A phase III trial, dubbed EMILIA, for 2nd-line treatment of advanced HER2+ breast cancer. Patient enrollment has been completed and results from this trial are expected next year.
- A phase III trial, known as MARIANNE, for 1st-line use in advanced HER2+ breast cancer.
- A phase II trial for adjuvant and neoadjuvant use in early stage HER2+ breast cancer. Data from this trial is expected to be available in the first quarter of 2012. ( Adjuvant therapy is treatment which is given in addition to main therapy and Neoadjuvant therapy is treatment which is given before the main treatment).
- A phase III trial for 3rd-line use in patients whose cancer was previously treated with HER2-targeted therapies. This trial was initiated in September of this year.
Last July, Roche submitted a Biologic License Application seeking accelerated approval for T-DM1 based on the results of a single-arm phase II study in advanced HER2+ breast cancer patients. But the accelerated approval filing for T-DM1 was rejected by the FDA in August 2010. According to Roche, T-DM1 has the potential to garner peak sales of anywhere from 2 billion to 5 billion Swiss Francs.
At the San Antonio Breast Cancer Symposium, ImmunoGen is scheduled to make several poster presentations on December 7, 2011, including a quality of life analysis of its lead TAP compound for breast cancer T-DM1 compared to Herceptin plus chemotherapy, the standard of care for HER2-positive metastatic breast cancer.
ImmunoGen has a rich pipeline comprising of wholly-owned product candidates as well as partnered compounds.
The drugs in development include, Lorvotuzumab mertansine (IMGN901), a CD56-targeting TAP compound for the treatment of small-cell lung cancer and other cancers like merkel cell carcinoma and multiple myeloma; IMGN529 to treat non-Hodgkin's lymphoma and other B-cell malignanices; IMGN853 for the treatment of ovarian cancer and other cancers that over-express folate receptor 1; SAR3419 for the treatment of CD19+ non-Hodgkin's lymphoma and other B-cell malignancies; BT-062 for the treatment of multiple myeloma, SAR650984 for a number of hematological malignancies; SAR566658 for the treatment of CA6-expressing cancers, which include many breast, ovarian, cervical, lung and pancreatic tumors; BAY 94-9343 against mesothelin-expressing tumors and two other Amgen-partnered compounds.
Lorvotuzumab mertansine (IMGN901) is wholly owned by ImmunoGen, and phase II evaluation of the compound for newly diagnosed small-cell lung cancer is on track to begin in early 2012. The expansion phase of phase I trial evaluating IMGN901 used in combination with standard care for multiple myeloma is also enrolling patients.
The other wholly owned ImmunoGen compounds are IMGN529 and IMGN853. While IMGN529 is expected to enter into phase I testing this quarter, IMGN853 remains on track to advance to active IND stage in the second quarter of 2012.
SAR3419, SAR650984 and SAR566658 are compounds being developed in collaboration with Sanofi-Aventis. A phase II trial evaluating SAR3419 as a treatment for diffuse large B-cell lymphoma and for B-cell acute lymphoblastic lymphoma was started by Sanofi-Aventis in October of 2011. SAR650984 and SAR566658 are also in phase I testing.
BAY 94-9343, which in development by Bayer HealthCare Pharmaceuticals, advanced into phase I clinical testing in September 2011.
A quick look at ImmunoGen's balance sheet...
In the first quarter of fiscal year 2012 ended September 30, 2011, ImmunoGen's net loss widened to $19.5 million or $0.26 per share from $12.9 million or $0.19 per share in the year-ago same quarter. Revenues were $2.5 million in the first quarter of fiscal year 2012, down from $3.4 million in the same period last year. The company derives its revenue from collaborative agreements.
As on September 30, 2011, ImmunoGen had zero debt and about $179.8 million in cash and cash equivalents.
Looking ahead to fiscal year ending June 30, 2012, ImmunoGen expects net loss to be between $65 million and $70 million. In fiscal year 2011, the company reported a net loss of $58.3 million or $0.85 per share on revenues of $19.3 million.
Over the past 1 year, IMGN has traded in a range of $8.06 to $16.20. The stock closed Monday's trading at $12.47, gaining 1.96%.
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