- First product with ImmunoGen's ADC technology, Kadcyla™, launched in the US. Multiple additional markets, indications expected.
- Three novel wholly owned ImmunoGen compounds advancing in clinical testing, with the first clinical data for IMGN853 to be reported at ASCO. Preclinical data for fourth compound, IMGN289, were reported at AACR, with clinical testing expected to begin later this year.
- First clinical findings reported at AACR for mesothelin-targeting partner compound, with clinical findings for additional compounds expected to be reported in 2013.
"Based on published clinical findings and patient anecdotes, we believe
Kadcyla will make a notable difference for many patients and become a
highly successful product," commented
Product Pipeline Update
Kadcyla (ado-trastuzumab emtansine, previously T-DM1) is a
HER2-targeting product with ImmunoGen's TAP technology that is being
developed and commercialized by Roche under an agreement with
February 22, 2013, Kadcyla gained US FDA marketing approval for the treatment of people with HER2-positive metastatic breast cancer (BC) who had received prior treatment with Herceptin® (trastuzumab) and a taxane chemotherapy. The product was launched shortly thereafter, and Roche reported Kadcyla sales of 18 million CHF (approximately $19.5 million) in its quarter ending March 31, 2013. Marketing applications are also under review in Europeand Japan, and Roche expects Kadcyla approval in Europeby late 2013.
Roche is developing Kadcyla for a number of additional indications. It expects data from its MARIANNE Phase III trial evaluating the product for first-line treatment of HER2-positive metastatic BC in early 2014 and to apply for marketing approval in the US and
Europefor this use in 2014. Roche is evaluating Kadcyla for the treatment of advanced HER2-positive gastric cancer in its GATSBY trial and expects to submit for approval for this use in 2015. Roche plans to also evaluate Kadcyla for the treatment of early stage HER2-positive BC in three different settings, with the first of these trials, KATHERINE, now underway.
IMGN901 is a CD56-targeting TAP compound wholly owned by ImmunoGen.
Patient enrollment is progressing well in the Company's NORTH Phase II trial assessing IMGN901 for the first-line treatment of small-cell lung cancer, used in combination with etoposide/carboplatin (E/C). The study design provides for an evaluation of the findings in the first 59 patients enrolled (39 randomized to IMGN901 plus E/C; 20 to E/C alone) that ImmunoGen had hoped would enable the Company to make certain development-related decisions in the later part of 2013. As reported earlier this month, ImmunoGen now anticipates making these decisions based on the findings in the full patient population of the trial due to a change in the starting dose during the trial, and expects to have data from this population in mid-2014.
IMGN853 is a folate receptor α (FOL)-targeting TAP compound wholly
owned by ImmunoGen.
Patient enrollment also is progressing well in the Company's first-in-human IMGN853 Phase I trial, and data from its dose-finding portion will be reported at the
American Society of Clinical Oncology(ASCO) annual meeting in June 2013. The expansion phase of this trial will evaluate IMGN853 specifically in patients with FOL-overexpressing ovarian cancer (OC), particularly platinum-resistant OC, and in patients with FOL-overexpressing adenocarcinoma non-small cell lung cancer (NSCLC).
IMGN529 is a potential treatment for CD37-positive hematological
malignancies including non-Hodgkin lymphoma (NHL); it is wholly owned
The Company expects to report clinical data from the IMGN529 first-in-human Phase I trial in
NHLat a medical conference in late 2013. This trial is currently in the dose-finding phase. Like Kadcyla, IMGN529 employs ImmunoGen's TAP technology with an antibody with anticancer properties of its own.
IMGN289 is a potential treatment for EGFR-overexpressing cancers,
including squamous cell carcinoma of the head and neck and NSCLC, and
is wholly owned by ImmunoGen.
The first preclinical data with IMGN289 were reported at the annual meeting of the
American Association for Cancer Research(AACR) and showed that IMGN289 can kill EGFR-overexpressing cancer via direct cell-killing as well as via EGFR-inhibition. Consequently, it was highly active against EGFR-overexpressing cancers, including those resistant to tyrosine kinase inhibitors and those not dependent on EGFR signaling. It also demonstrated potential for a favorable tolerability profile.
The Company expects to submit the IMGN289 Investigational New Drug (IND) application in mid-2013 and to begin its clinical testing in 2H 2013.
In addition to Kadcyla, seven other compounds are in clinical testing
through ImmunoGen's partnerships, with additional compounds in earlier
stages of development.
The first clinical data were reported at AACR for the mesothelin-targeting TAP compound, BAY 94-9343, in development by
Bayer HealthCare. These data were from the dose-escalation part of the first-in-human Phase I trial and showed the compound was generally well tolerated and demonstrated evidence of activity among patients treated at higher dose levels. The compound is now being evaluated specifically in patients with either mesothelioma or OC in the expansion phase of this trial.
ImmunoGen expects clinical data to be reported for most, if not all, of the remaining six clinical-stage partner compounds in 2013.
Financial Results and Guidance
ImmunoGen reported a net loss of
Revenues for 3Q FY2013 were
Operating expenses for 3Q FY2013 were
ImmunoGen had approximately
ImmunoGen now expects its net loss for its fiscal year ending
This compares with previous guidance, issued in
"We expect our net cash used in operations to be lower than previously
projected — driving our ending cash balance higher — primarily because
of lower than expected operating expenses and working capital needs,"
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 2013 fiscal
year; its cash and cash equivalents as of
|SELECTED FINANCIAL INFORMATION|
|(in thousands, except per share amounts)|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||$||206,103||$||160,938|
|LIABILITIES AND SHAREHOLDERS' EQUITY|
|Long-term portion of deferred revenue and other long-term liabilities||72,866||80,164|
|Total liabilities and shareholders' equity||$||228,682||$||180,308|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|Three Months Ended||Nine Months Ended|
|License and milestone fees||$||22,010||$||999||$||23,372||$||8,211|
|Research and development support||2,257||1,320||5,670||$||3,333|
|Clinical materials reimbursement||734||933||2,662||1,861|
|Research and development||21,318||16,933||66,674||49,653|
|General and administrative||4,995||5,021||16,098||14,696|
|Total operating expenses||26,313||21,954||82,772||64,349|
|Loss from operations||(1,312||)||(18,702||)||(51,068||)||(50,944||)|
|Other (expense) income, net||(39||)||33||132||39|
|Net loss per common share, basic and diluted||$||(0.02||)||$||(0.24||)||$||(0.61||)||$||(0.66||)|
|Weighted average common shares outstanding, basic and diluted||84,279||76,961||83,923||76,615|
Executive Director, Investor Relations and Corporate Communications
The Yates Network
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