(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, 2012 and provided an update on the Company.
“We believe the trastuzumab emtansine clinical data reported at ASCO convey the transformational potential of our TAP technology,” commented Daniel Junius, President and CEO. “It is impressive to see a new product candidate demonstrate both greater efficacy and better tolerability than standard care, and is noteworthy that these benefits were seen for a cancer in which considerable progress already had been made. It also was significant that these were found in a solid tumor indication – approximately ninety percent of cancer diagnoses are for solid tumors and very few antibody-based therapies have been effective for these cancers.”
Mr. Junius continued, “Roche continues to make important progress with trastuzumab emtansine, not only advancing it toward marketing application submission this year, but also broadening the clinical program to extend into early stage HER2+ breast cancer. At the same time, we are making visible progress building and advancing our proprietary product pipeline while other of our partners also are advancing toward pivotal testing.”
Product Pipeline Update
- Lead compound trastuzumab emtansine, in development globally by Roche:
- Most advanced indication – Positive results from Roche’s first trastuzumab emtansine Phase III trial, EMILIA, were presented at the 2012 American Society of Clinical Oncology (ASCO) annual meeting in the plenary session. EMILIA assessed trastuzumab emtansine in patients with HER2+ metastatic breast cancer (BC) who previously had been treated with Herceptin® (trastuzumab) and with a taxane. Roche expects to apply in 2012 for marketing approval of trastuzumab emtansine for this use in the US and Europe.
- First-line for HER2+ metastatic BC – Patient enrollment has completed in the Phase III trial, MARIANNE, evaluating trastuzumab emtansine for this use. Roche expects to use this trial to apply in 2014 for marketing approval of trastuzumab emtansine for the first-line treatment of this cancer in the US and Europe.
- For early stage HER2+ BC – In early June, Roche outlined its plans to initiate three more trastuzumab emtansine registration trials in 2013, evaluating the compound for neoadjuvant use, for adjuvant use and to treat residual invasive disease following surgery. It anticipates having pathological complete response (pCR) data from the neoadjuvant trial during 2015.
Fiscal Year 2012 Financial Results
- IMGN901, ImmunoGen’s lead wholly owned compound:
- For first-line treatment of small-cell lung cancer (SCLC) – Patient enrollment is ongoing in the NORTH Phase II trial, with 28 sites now open. The Company expects to be able to use this trial to make the decisions necessary to advance IMGN901 into pivotal testing.Additionally, ImmunoGen expects to report clinical findings on the IMGN901 dose established for use in combination with etoposide/carboplatin at the Chicago Multidisciplinary Symposium in Thoracic Oncology in early September. The patient population for this Phase I evaluation was not limited to first-line SCLC.
- For relapsed multiple myeloma – The Company expects to report findings from the Phase I trial assessing IMGN901 used in combination with Revlimid® (lenalidomide)/ dexamethasone at a medical conference in late 2012.
- IMGN853, ImmunoGen’s wholly owned folate receptor α (FOLR)-targeting TAP compound, began clinical testing in June 2012. Its Phase I trial is designed to first define IMGN853’s maximum tolerated dose and dose-limiting toxicity and then to evaluate it to treat specific types of FOLR-overexpressing cancers. ImmunoGen expects to be able to use this trial to make the decisions necessary to advance IMGN853 into pivotal testing.
- IMGN529, ImmunoGen’s wholly owned TAP compound for the treatment of CD37+ hematologic malignancies, entered clinical testing in April 2012 for the treatment of previously treated non-Hodgkin’s lymphoma. The Company expects to report the first clinical data with IMGN529 in 2013.
- Other clinical-stage compounds – In addition to trastuzumab emtansine, seven other compounds are in clinical testing through ImmunoGen’s collaborative partnerships.
- The Company expects up to three of these compounds to advance into pivotal testing by late 2013.
- SAR3419 – Encouraging Phase I data were reported with SAR3419 at ASCO. ImmunoGen believes the first Phase II data with this CD19-targeting TAP compound could be presented at a medical meeting in late 2012.
For the Company’s fiscal year ended June 30, 2012 (FY2012), ImmunoGen reported a net loss of $73.3 million, or $0.95 per basic and diluted share, compared to a net loss of $58.3 million, or $0.85 per basic and diluted share, for its fiscal year ended June 30, 2011 (FY2011). For the quarter ending June 30, 2012, ImmunoGen reported a net loss of $22.4 million, or $0.29 per basic and diluted share, compared to a net loss of $16.2 million, or $0.23 per basic and diluted share, for the same quarter in FY2011.