(Nasdaq: IMGN), a biopharmaceutical company that develops anticancer products using its Targeted Antibody Payload (TAP) technology and antibody expertise, today reported financial results for the three-month period ended September 30, 2012 – the first quarter of the Company’s 2013 fiscal year – and provided an update on the Company.
“In the past few months, the results from the T-DM1 Phase III EMILIA trial have been used as the basis for Roche’s marketing submissions, reported in oral presentations at ASCO and ESMO, and published in the
New England Journal of Medicine
,” commented Daniel Junius, President and CEO. “Roche has continued to expand the potential commercial opportunity for T-DM1, into earlier stages of HER2+ breast cancer and now also into HER2+ gastric cancer. We believe T-DM1 has the potential to rapidly become a highly successful product that makes a real difference for appropriate patients.”
Mr. Junius continued, “Many other, earlier stage TAP compounds are also making meaningful progress. Of particular importance, we now have three wholly owned TAP compounds in clinical testing, and expect to submit an IND for our fourth by mid-2013. We believe the potential value of these TAP compounds will become more apparent over the course of 2013.”
Product Pipeline Update
- T-DM1, in global development by Roche:
- Marketing applications submitted for lead indication – In August, Roche applied for marketing approval in the US and Europe of T-DM1 for the treatment of HER2+ metastatic breast cancer (BC) in patients who had previously received Herceptin®. T-DM1 was found to significantly improve both overall survival and progression-free survival compared to standard-of-care in the EMILIA Phase III trial and was associated with fewer Grade 3 or greater (severe) adverse events.
- Progress in Phase III trial, MARIANNE, for first-line treatment of HER2+ metastatic BC – Patient enrollment was completed this spring, and Roche now expects data from this trial in late 2013/early 2014, which is earlier than originally projected.
- Registration trials in early stage HER2+ BC on track to start in 2013 – Roche plans to evaluate T-DM1 for neoadjuvant use, for adjuvant use and for treatment of residual invasive disease following surgery.
- Assessment for metastatic HER2+ gastric cancer underway – Roche has initiated a trial assessing T-DM1 for second-line treatment of this disease and expects to apply for marketing approval for this use in 2015.
Financial Results and Guidance
- IMGN901, ImmunoGen’s lead wholly owned compound:
- Patient enrollment progressing in NORTH trial –Thirty-three sites across four countries are now participating in this randomized Phase II trial assessing IMGN901 as part of a combination regimen for first-line treatment of small-cell lung cancer. The Company expects to report the first findings from this Phase II assessment in the second half of 2013. Findings from its dose-finding Phase I assessment were reported at medical meetings in September and October.
- Multiple myeloma data to be presented at American Society of Hematology (ASH) annual meeting– Data from the Phase I trial assessing IMGN901 as part of a combination regimen for this cancer will be reported in an oral presentation at the ASH annual meeting in December.
- IMGN853, ImmunoGen’s wholly owned folate receptor α (FOLR)-targeting TAP compound:
- Patient enrollment in the Phase I trial is underway at several sites in the US.
- ImmunoGen expects to report the first clinical data with IMGN853 in 2013.
- IMGN529, ImmunoGen’s wholly owned TAP compound for non-Hodgkin’s lymphoma:
- The study protocol was successfully amended to allow use of single-patient cohorts during dose escalation.
- Patient enrollment is underway at an expanding number of clinical centers.
- ImmunoGen expects to report the first clinical data with IMGN529 in 2013.
- Other clinical-stage compounds – In addition to T-DM1, seven other compounds are in clinical testing through ImmunoGen’s collaborative partnerships.
- The Company expects clinical data to be reported for most, if not all, of these compounds in 2013.
ImmunoGen reported a net loss of $25.2 million, or $0.30 per basic and diluted share, for the quarter ending September 30, 2012 (1Q FY2013), as compared to a net loss of $19.5 million, or $0.26 per basic and diluted share, for the same quarter of the last year (1Q FY2012).