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ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that develops targeted anticancer products using its antibody expertise and Targeted Antibody Payload (TAP) technology, today reported financial results for the three-month period and fiscal year ended June 30, 2011.
“Our product pipeline is both advancing and broadening, increasingly through our own progress as well as through that of our partners,” commented Daniel Junius, President and CEO. “Trastuzumab emtansine, or T-DM1, continues to be the most advanced compound, with Roche expecting to report data from the EMILIA Phase III trial by mid-2012 and to apply for marketing approval in the US and Europe soon after. We expect as many as three other TAP compounds to have started Phase II testing by mid-2012, including our wholly owned IMGN901 compound. We also expect five additional TAP compounds to enter the clinic during this time period, including our wholly owned IMGN529 and IMGN853 product candidates.”
Clinical-Stage Product Candidates
Trastuzumab emtansine (T-DM1) – In global development by Roche for the treatment of HER2+ breast cancer (BC) under a licensing agreement with ImmunoGen.
2nd-line metastatic BC – Roche expects to report data from the Phase III EMILIA trial by mid-2012 and to apply in 2012 for marketing approval in the US and Europe.
1st-line metastatic BC – Mature data from the completed Phase II trial have been submitted for presentation at the ESMO annual meeting in September 2011. Roche expects to apply for marketing approval for this use in 2014 with data from the MARIANNE Phase III trial.
Other – Roche initiated a Phase II safety trial in the adjuvant/neoadjuvant BC setting in 4Q2010. Separately, the compound was found to be active against gastric cancer in several recently published preclinical studies.
Lorvotuzumab mertansine (IMGN901) – wholly owned ImmunoGen product candidate for small-cell lung cancer (SCLC) and other CD56+ cancers.
SCLC – Continued progress is being made in the Phase I trial designed to establish the dose of IMGN901 plus etoposide/carboplatin (E/C) to be used in later-stage clinical testing. The Company expects to begin assessment of this combination to treat newly diagnosed metastatic SCLC in a randomized Phase II trial in late 2011/early 2012 and to report initial data from that trial in 2H2012.
Merkel cell carcinoma (MCC) – The Company anticipates the IMGN901 plus E/C dose being established could be used in an MCC pivotal trial should the Company determine there is a benefit in aggressively developing IMGN901 for MCC as well as for SCLC.
Multiple myeloma – Positive data from a Phase I trial evaluating the compound in combination with lenalidomide (Revlimid®)/dexamethasone were presented at ASCO in June 2011, and patient enrollment is underway in the expansion phase of this study. The trial evaluating IMGN901 used alone to treat this cancer has been completed.
SAR3419 – ImmunoGen-created CD19-targeting TAP compound in development by Sanofi for non-Hodgkin’s lymphoma (NHL).
Phase I clinical data were presented at ASCO and in an oral presentation at the 11 th International Conference on Malignant Lymphoma in June 2011 that showed the compound achieved a 33% objective response rate when given at its maximum tolerated dose to patients with relapsed/refractory NHL. SAR3419 demonstrated activity against rituximab (Rituxan®)-resistant and -responsive disease and across histological tumor types.
Sanofi expects to begin Phase II testing of SAR3419 in 2H2011. Its clinical program is designed to support the rapid progression of the compound into pivotal testing.
IMGN388, SAR650984, SAR566658 and BT-062 are progressing in early-stage clinical testing through programs being implemented by ImmunoGen, Sanofi (2), and Biotest, respectively. The IND for an additional TAP compound, BAY 94-9343, has been submitted by Bayer HealthCare Pharmaceuticals.