(Nasdaq: IMGN), a biotechnology 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 December 31, 2012 – the second quarter of the Company’s 2013 fiscal year – and provided an update on the Company.
“We expect 2013 to be a very important year for ImmunoGen,” commented Daniel Junius, President and CEO. “Roche is anticipating the approval of T-DM1 in the US early this year followed by approval in Europe later in 2013. We believe the launch of T-DM1 will be momentous for appropriate patients, their families, and their physicians. It will also mark the start of ImmunoGen earning what we believe will be a significant royalty stream.”
Mr. Junius continued, “We also believe that, in 2013, ImmunoGen’s progress on our proprietary pipeline will become more apparent. Over the course of the year, we expect to report clinical findings for our three lead TAP compounds and to advance our fourth, IMGN289, into clinical testing. We believe each of these compounds has the potential to be transformative to the treatment of its targeted cancer and we’ve designed development programs to advance each compound through proof of concept as promptly as possible.”
Product Pipeline Update
- Lead compound with ImmunoGen’s TAP technology, T-DM1, is in global development by Roche:
- The T-DM1 marketing applications for treatment of people with HER2+, unresectable locally advanced or metastatic breast cancer who have received prior treatment with Herceptin® (trastuzumab) and a taxane are under review in the US and Europe. Roche has noted that the US submission has been granted priority review status by the FDA with a PDUFA goal date of February 26, 2013. Roche also expects European approval of T-DM1 in 2013.
- Roche expects to report data from its Ph III trial, MARIANNE, evaluating T-DM1 for first-line treatment of HER+ metastatic breast cancer in early 2014 and to apply for marketing approval for this use in 2014.
- Roche intends to initiate registration trials in 2013 evaluating T-DM1 in three early stage HER2+ breast cancer settings – adjuvant, neoadjuvant, and residual invasive disease.
- Roche is currently evaluating T-DM1 for the treatment of advanced HER2+ gastric cancer and expects to submit for approval for this use in 2015.
Financial Results and Guidance
- IMGN901, wholly owned ImmunoGen TAP compound for CD56+ cancers:
- Small-cell lung cancer (SCLC) – The Company remains on track to have the data readout from the first stage of its Simon two-stage NORTH Phase II trial in the second half of 2013 – a readout designed to inform certain development decisions to be made by the Company. ImmunoGen expects to complete patient enrollment for the full trial in 2013, which would enable these findings to be reported in 2014. NORTH evaluates IMGN901 for the first-line treatment of SCLC used in combination with etoposide/carboplatin.
- Multiple myeloma – IMGN901 showed activity in both Revlimid® (lenalidomide)-naïve and -refractory disease in a Phase I trial assessing it used in combination with Revlimid and dexamethasone presented at the ASH annual meeting in December.
- IMGN853, ImmunoGen TAP compound for folate receptor α (FOL)-overexpressing tumors:
- The Company expects the first clinical data with this TAP compound to be reported at a medical conference in mid-2013.
- IMGN853 is a potential treatment for prevalent types of ovarian and non-small cell lung cancers, as well as for other FOL+ solid tumors.
- IMGN529, ImmunoGen TAP compound for CD37+ hematological malignancies:
- IMGN529 is in Phase I testing for the treatment of non-Hodgkin’s lymphoma, and the Company expects the first clinical data to be reported at a medical conference in late 2013.
- IMGN529 employs ImmunoGen’s TAP technology with an antibody that also has anticancer properties.
- IMGN289, ImmunoGen TAP compound for EGFR-overexpressing solid tumors:
- IMGN289 is expected to be the next wholly owned ImmunoGen compound to advance into clinical testing. The Company expects to submit its IND in mid-2013 and to begin clinical testing in 2H 2013.
- ImmunoGen expects to present data on the preclinical efficacy and tolerability of IMGN289 at a scientific meeting in 2Q 2013.
- In addition to T-DM1, seven other compounds are in clinical testing through ImmunoGen’s partnerships:
- Clinical data are expected to be reported with a number of these compounds in 2013.
- A partner compound is projected to advance into pivotal testing in 2013.
ImmunoGen reported a net loss of $24.4 million, or $0.29 per basic and diluted share, for the quarter ending December 31, 2012 (2Q FY2013), as compared to a net loss of $12.8 million, or $0.17 per basic and diluted share, for the same quarter of the last year (2Q FY2012).