(Nasdaq: IMGN), a biotechnology company that develops novel anticancer therapeutics using its antibody-drug conjugate (ADC) technology, today reported financial results for the three-month period ended September 30, 2013 – the first quarter of the Company’s 2014 fiscal year. ImmunoGen also provided an update on Kadcyla
, the Company’s wholly owned product candidates, other partner programs and the latest additions to its industry-leading ADC technology portfolio.
“Kadcyla is already making a difference for many patients in the US, and the number of countries in which it is available internationally is increasing rapidly,” commented Daniel Junius, President and CEO. “We believe its lead indication provides a meaningful market opportunity for Kadcyla, with many additional indications in development by Roche.”
Mr. Junius continued, “Achievements with our wholly owned clinical-stage product candidates include completion of patient enrollment in our NORTH Phase II trial with IMGN901, which keeps us on track to make next-step decisions for this product candidate by mid-2014. We are making progress with IMGN853 and expect to report disease-specific Phase I data mid next year. In 2014, we also expect to report the first clinical findings with IMGN529 and potentially the first data with our newest clinical-stage compound, our EGFR-targeting IMGN289. These different product candidates reflect many enhancements we have made to our ADC technology portfolio in recent years, and our presentations at the recent AACR-NCI-EORTC conference underscore our ongoing commitment to leadership in the ADC field.”
Kadcyla (ado-trastuzumab emtansine)
Kadcyla utilizes ImmunoGen’s ADC technology with Roche’s Herceptin
(trastuzumab) antibody and is being developed and commercialized by Roche under an agreement with ImmunoGen. Recent developments include:
ImmunoGen Wholly Owned Product Candidates
- Sales development in the US, a positive CHMP opinion for the European Union, and approvals and/or launches in additional countries, including approval in Japan.
- Roche reported Kadcyla sales year-to-date September 30, 2013 were 152 million CHF in the US and 4 million CHF ex-US (in total, approximately $168 million). ImmunoGen receives and recognizes royalties on Kadcyla sales the quarter after the quarter in which Roche records the sales.
- Positive results from the TH3RESA trial were presented at the 2013 European Cancer Congress.
- Roche reported its plans to conduct a pivotal trial assessing Kadcyla for neoadjuvant use in early stage HER2-positive breast cancer. It expects to start this trial in 2Q2014 and for the pCR (pathological complete response) data to be available in late 2015.
- Roche continues to expect results from its first-line MARIANNE trial in 2014. It expects to apply in 2015 for marketing approval of Kadcyla for first-line treatment of HER2-positive metastatic breast cancer with MARIANNE data and for treatment of advanced HER2-positive gastric cancer with GATSBY data.
IMGN901 is in Phase II testing for the first-line treatment of extensive disease small-cell lung cancer. An ADC, IMGN901 targets CD56.
- Patient enrollment in the Phase II NORTH trial was completed in late September 2013.
- ImmunoGen expects to have the data needed to make IMGN901 next-step decisions by mid-2014 and to report data from this trial at one or more medical conferences in 2014.
IMGN853 is a folate receptor α (FRα)-targeting ADC in Phase I testing for the treatment of FRα-positive solid tumors, which include many ovarian and endometrial cancers as well as certain non-small cell lung cancers.
- ImmunoGen expects to report the first disease-specific data with IMGN853 in mid-2014.
IMGN289 is an EGFR-targeting ADC and ImmunoGen’s third wholly owned compound for solid tumor indications. It is a potential new treatment for squamous cell lung, head and neck, and other EGFR-positive cancers, including those resistant to EGFR inhibition.
- Its Investigational New Drug (IND) application is active and the Company expects patient dosing in Phase I testing to begin this quarter.
IMGN529, ImmunoGen’s lead compound for hematological malignancies, is in Phase I testing for the treatment of non-Hodgkin lymphoma (NHL). An ADC, IMGN529 targets CD37, which is also on chronic lymphocytic leukemia.
Other Partner Programs
- ImmunoGen expects to report the first IMGN529 clinical data in 2014 and also to begin its assessment in NHL subtypes in 2014.
Multiple leading companies in oncology are developing anticancer compounds through partnerships with ImmunoGen. Companies licensing limited rights to use ImmunoGen’s ADC technology include Amgen, Bayer HealthCare, Biotest, Eli Lilly, Novartis, Roche and Sanofi. In addition to Kadcyla, seven other compounds are in clinical testing through ImmunoGen’s collaborative partnerships.
- Clinical data for three partner compounds – SAR3419, SAR650984, and BT-062 – have been accepted for presentation at a medical meeting in December 2013.
- ImmunoGen expects clinical data for one or more partner compounds to be reported at the American Association for Cancer Research (AACR) and American Society of Clinical Oncology (ASCO) annual meetings in April and May/June 2014, respectively.
- ImmunoGen expects one or more partner IND submissions in 2014.
The first clinical data for SAR566658 were reported at an AACR-NCI-EORTC conference earlier this month.
ImmunoGen ADC Technology
- SAR566658 is in development for the treatment of CA6-positive cancers, which include certain breast and ovarian cancers.
- In the dose-finding portion of this Phase I trial, SAR566658 was found to be generally well tolerated and a recommended dose was established for further clinical testing of the compound. Objective responses and stable disease were reported.
There is notable clinical support for ImmunoGen’s tubulin-acting maytansinoid ADC technology, including the findings in Phase II and III randomized trials with Kadcyla as well as Phase I findings for multiple product candidates.
- Objective responses and sustained clinical benefit have been reported with ImmunoGen and partner ADCs for many different types of cancers.
The Company continues to further augment its technology portfolio to extend the potential for effective, well-tolerated ADCs while maintaining its leadership in the field.
- Multiple engineered linkers have been developed by the Company and introduced into new ADCs, with clinical findings reported.
- ImmunoGen scientists have developed a new class of payload agents, DNA-acting IGNs, to extend the opportunity for ADCs to include cancers not responsive to tubulin-acting agents, those with low levels of antigen expression, and those with multidrug resistance.
For the Company’s quarter ended September 30, 2013 (1Q FY2014), ImmunoGen reported a net loss of $11.2 million, or $0.13 per basic and diluted share, compared to a net loss of $25.2 million, or $0.30 per basic and diluted share, for the same quarter last year (1Q FY2013).