- Trastuzumab emtansine (T-DM1) progress includes achievement of progression-free survival (PFS) endpoint in lead Phase III trial for HER2+ metastatic breast cancer. Data from this trial and the Phase II safety trial in (neo)adjuvant setting submitted to ASCO for presentation.
- Progress with wholly owned product candidates includes start of Phase II testing with IMGN901, initiation of Phase I evaluation of IMGN529, and advancement of IMGN853 to active IND stage.
"The progress being made by us and our partners is accelerating,"
Product Pipeline Progress — Key Updates
Lead compound, trastuzumab emtansine, which is in development by Roche under an agreement with ImmunoGen:
For HER2+ metastatic breast cancer (mBC) — Roche reported that the PFS
endpoint was met in the EMILIA Phase III trial and that it will apply
in 2012 for marketing approval of trastuzumab emtansine in the US and
Europe. EMILIA evaluates the compound for the treatment of patients with HER2+ mBC who previously had received trastuzumab (Herceptin®) and a taxane in any setting (adjuvant or metastatic).
- Roche reported that the study data were submitted to ASCO for presentation at the annual meeting in June.
- The MARIANNE and TH3RESA Phase III trials underway evaluate trastuzumab emtansine in additional HER2+ mBC patient populations.
For HER2+ early breast cancer (eBC) — Roche reported that the data
from the Phase II safety trial in the (neo)adjuvant setting also were
submitted to ASCO for presentation.
- Roche has said that it intends to provide an update on its eBC plans in mid-2012.
Lead wholly owned ImmunoGen product candidates:
IMGN901 — In
March 2012, began Phase II testing for first-line treatment of small-cell lung cancer, used in combination with carboplatin and etoposide (C/E), in the NORTH trial.
- Phase I data for IMGN901 with C/E were submitted for presentation at a medical meeting taking place in 3Q 2012.
- Compound is also in clinical testing to treat multiple myeloma.
IMGN529 — In
April 2012, this CD37-targeting product candidate began Phase I testing for non-Hodgkin's lymphoma.
- Two posters on IMGN529 were presented at the AACR annual meeting in April: one on its safety and activity in preclinical assessment and one on the CD37 expression diagnostic developed.
IMGN853 — In
April 2012, this potential treatment for folate receptor 1 (FOLR1)-expressing solid tumors advanced to having an active investigational new drug (IND) application.
- Phase I testing is expected to begin in mid-2012.
- A preclinical poster on IMGN853 also was presented at AACR.
Other partner compounds:
SAR3419, which was created by ImmunoGen and licensed to Sanofi in a broader collaboration.
- Clinical data with the dose selected for Phase II testing have been submitted to ASCO for presentation.
Three Phase II trials are underway with
Six other compounds are in clinical testing through ImmunoGen
collaborations with Amgen,
Bayer HealthCare, Biotest, and Sanofi.
Financial Results and Guidance
ImmunoGen reported a net loss of
Operating expenses for 3Q FY2012 were
ImmunoGen had approximately
ImmunoGen's financial guidance remains unchanged from that issued in
"In addition to our visible progress with IMGN901, IMGN529 and IMGN853,
we also continue to invest in earlier-stage product candidates and in
our technology," commented
Conference Call Information
ImmunoGen is holding a conference call today at
Herceptin® is a registered trademark of
This press release includes forward-looking statements based on
management's current expectations. These statements include, but are not
limited to, ImmunoGen's expectations related to: the Company's net loss,
cash used in operations and capital expenditures in its 2012 fiscal
year; its cash and marketable securities as of
|SELECTED FINANCIAL INFORMATION|
|(in thousands, except per share amounts)|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||$||175,260||$||191,206|
|LIABILITIES AND SHAREHOLDERS' EQUITY|
|Long-term portion of deferred revenue and other long-term liabilities||80,600||63,106|
|Total liabilities and shareholders' equity||$||196,328||$||217,641|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|Three Months Ended||
Nine Months Ended
|Research and development support||$||1,320||$||2,190||$||3,333||$||5,690|
|License and milestone fees||999||858||8,211||3,534|
|Clinical materials reimbursement||933||2,163||1,861||3,576|
|Research and development||16,933||15,763||49,653||45,192|
|General and administrative||5,021||4,550||14,696||11,602|
|Total operating expenses||21,954||20,313||64,349||56,794|
|Loss from operations||(18,702||)||(15,102||)||(50,944||)||(43,994||)|
|Other income, net||33||99||39||1,870|
|Net loss per common share, basic and diluted||$||(0.24||)||$||(0.22||)||$||(0.66||)||$||(0.62||)|
|Weighted average common shares outstanding, basic and diluted||76,961||68,067||76,615||67,996|
Executive Director, Investor Relations and Corporate Communications
The Yates Network
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