. (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 March 31, 2014 – the third quarter of the Company’s 2014 fiscal year. ImmunoGen also provided an update on Company and partner product programs.
“The expanding amount of encouraging clinical data being reported by us and our partners reflects the investments we have made in our technology and in our product development capabilities,” commented Daniel Junius, President and CEO. “Earlier this month, we reported clinical data showing that our change to the dosing calculation for IMGN853 appears to have had the desired effect, and we are pleased with the dose levels being achieved. There continues to be strong investigator interest in our IMGN289 EGFR-targeting ADC, which has enabled dose escalation to already be reaching potentially therapeutic dose levels. Dose escalation with IMGN529 has resumed, as noted previously, and this compound for B-cell malignancies is now being administered at doses above those where anticancer activity was first seen.”
Mr. Junius continued, “Kadcyla sales are off to a good start, with the results from its next registration trial – MARIANNE – expected later this year. Encouraging initial clinical data were reported with Amgen’s AMG 595 earlier this month, and we expect the body of clinical data around our compounds and those of our partners to increase substantially in 2014.”
ImmunoGen Wholly Owned Product Candidates
IMGN853 – This ADC is a potential treatment for folate receptor α-positive cancers, including many ovarian, endometrial and lung cancers.
- Initial findings reported at the annual meeting of the American Association of Cancer Research (AACR) earlier this month showed the change made in dose calculation – from use of total body weight (TBW) to adjusted ideal body weight (AIBW) – appears to have achieved its objective: none of the six patients treated with IMGN853 at 5 mg/kg AIBW had ocular toxicity compared with four of ten using TBW. Evidence of activity has been seen with IMGN853 at doses of 3.3 mg/kg (TBW) and above, as previously reported.
- Additional IMGN853 clinical data are to be presented at the upcoming annual meeting of the American Society of Clinical Oncology (ASCO).
- The Company expects to establish the maximum tolerated dose of IMGN853 with the current once every 3 weeks dosing schedule this quarter and to begin assessing IMGN853 specifically in patients with platinum-resistant ovarian cancer or relapsed endometrial cancer. The first disease-specific data are expected to be reported later this year.
- IMGN853 also is being assessed using a modified weekly dosing schedule, to enable the best schedule to be used as it advances.
IMGN529 – This CD37-targeting ADC is a potential new treatment for B-cell malignancies, including non-Hodgkin lymphoma.
- The first clinical findings with IMGN529 are scheduled for presentation at ASCO.
IMGN289 – This EGFR-targeting ADC is a potential new treatment for many epithelial tumors, including squamous cell head/neck and lung cancers.
- The Company reported preclinical data at AACR on the activity of IMGN289 against tyrosine kinase inhibitor (TKI)-resistant EGFR-positive cancers.
- Dose-escalation is ongoing in the IMGN289 Phase I clinical trial, with updates – initial data and/or development events – expected in the second half of 2014.
Roche’s Kadcyla (ado-trastuzumab emtansine) is the first marketed product utilizing ImmunoGen’s ADC technology.
- Sales – Roche reported global Kadcyla sales of 102 million CHF (approximately $115 million) for the first quarter of 2014 (January-March, 2014). Launch of Kadcyla has begun in some countries in the EU and is ongoing in the US; launch in Japan began last week. ImmunoGen receives and recognizes royalties on Kadcyla sales in the quarter after the quarter in which Roche records the sales.
- First-line for HER2-positive metastatic breast cancer – Roche expects results from its MARIANNE Phase III trial to be reported in the second half of 2014, and – with positive results – to submit in 2015 for regulatory approval.
- Advanced HER2-positive gastric cancer – Roche is evaluating Kadcyla for second-line use in this disease in its GATSBY trial. Regulatory submission – with positive results – is expected in 2015.
- Early stage HER2-positive breast cancer – Roche has three Phase III trials with Kadcyla: KAITLIN, for adjuvant use, which is underway; KATHERINE, for residual invasive disease, which is underway; and KRISTINE, for neo-adjuvant use, which is expected to start this quarter.
A number of leading companies in oncology are developing anticancer compounds through partnerships with ImmunoGen. Recent updates include:
- The first clinical data with Amgen’s AMG 595 in glioblastoma were reported at AACR, with evidence of activity seen at doses that were well tolerated.
- With the presentation of the AMG 595 data at AACR, encouraging initial clinical findings have now been reported for six partner compounds in addition to Kadcyla: Amgen’s AMG 595, Bayer HealthCare’s BAY 94-9343 (anetumab ravtansine), Biotest’s BT-062 (indatuximab ravtansine), Sanofi’s SAR3419 (coltuximab ravtansine), SAR566658, and SAR650984.
- Patient dosing has begun in a clinical trial assessing CD138-targeting BT-062 for the treatment of triple negative metastatic breast cancer and metastatic urinary bladder cancer. BT-062 also is in clinical testing for the treatment of multiple myeloma. ImmunoGen has a BT-062 opt-in right for co-development and co-commercialization jointly with Biotest in the US.
- ImmunoGen expects one or more partner IND submissions in 2014, plus additional clinical data presentations.
For the Company’s quarter ended March 31, 2014 (3Q FY2014), ImmunoGen reported a net loss of $37.5 million, or $0.44 per basic and diluted share, compared to a net loss of $1.4 million, or $0.02 per basic and diluted share, for the same quarter last year (3Q FY2013). Included in the current period is a $12.8 million ($0.15/share) non-cash expense related to the collaboration recently established with CytomX.