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Immunogen Reports First Quarter Fiscal Year 2016 Financial Results

The following excerpt is from the company's SEC filing.

and Provides Corporate Update

Level of target expression on patient tumors may have a marked impact on response to mirvetuximab soravtansine, ImmunoGens novel folate receptor α (FRα)-targeting antibody-drug conjugate (ADC); data to be reported at AACR-NCI-EORTC in November.

Patient enrollment completed in Phase 1 ovarian cancer cohort that ImmunoGen plans to discuss with regulators in 2016. Company on track to initiate trials designed to potentially support an Accelerated Approval pathway (FORWARD I) and market expansion (FORWARD II) for mirvetuximab s oravtansine.

Broader pipeline progress includes advancement of another ImmunoGen ADC and three partner ADCs to IND/clinical testing.

WALTHAM, MA, October 27, 2015

ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that develops targeted anticancer therapeutics using its ADC technology, today reported financial results for the three-month period ended September 30, 2015 the first quarter of the Companys 2016 fiscal year. ImmunoGen also provided an update on product programs and reiterated its guidance for its 2016 fiscal year.

We believe mirvetuximab soravtansine has the potential to make an important difference for many patients with FRα-positive cancers and look forward to the upcoming data presentations at AACR-NCI-EORTC, commented Daniel Junius, President and CEO. Of particular note are the findings suggesting that the level of FRα expression on patient tumors has a marked impact on response to mirvetuximab soravtansine. As noted in the abstract that became public yesterday, the response rate was 53% for the patients reported at ASCO and 80% in the subset with the highest expression about half of the 22 patients treated. Updated response data, including duration, for these patients will be reported at AACR-NCI-EORTC.

Mr. Junius continued, We are successfully executing on all of our product programs completing enrollment in the 40-patient ovarian cancer Phase 1 expansion cohort well ahead of plan, moving forward with combination strategies for our two ADCs for B-cell malignancies, and submitting the IND for our fourth wholly owned program, IMGN779, to the FDA on schedule. There also has been notable progress by a number of our partners.

Updates on Product Programs

Mirvetuximab soravtansine

(formerly IMGN853) for FRα-positive cancers including ovarian cancer.

Data presentations

at the upcoming AACR-NCI-EORTC conference will feature:

Findings from an analysis of the relationship between level of

α expression on patient tumor cells and response to treatment with mirvetuximab soravtansine (abstract C47).

This analysis indicates patients with higher levels of target expression on their tumors are more likely to respond to treatment with mirvetuximab soravtansine. The findings helped inform that FORWARD I would enroll patients with medium or high levels of expression, with stratification by expression level.

Preclinical evaluation of mirvetuximab soravtansine combination therapy

(abstract C170) provides findings on mirvetuximab soravtansine used in combination with bevacizumab (Avastin®) and the other agents to be assessed in FORWARD II.

Clinical progress:

patient enrollment completed ahead of plan in the Phase 1 40-patient expansion cohort assessing mirvetuximab soravtansine monotherapy for FRα-positive platinum-resistant ovarian cancer. Patient enrollment is also ahead of plan in the 20-patient ovarian cancer cohort examining biomarkers using biopsies taken before and on treatment, and is progressing in the endometrial cancer expansion cohort. Data presentation for each of these cohorts is targeted for 2Q2016. Cohorts for additional types of FRα-positive cancers are expected to be added to this Phase 1 trial.

Phase 2 testing:

ImmunoGen remains on track to initiate its FORWARD I and FORWARD II trials by year end. FORWARD I evaluates mirvetuximab soravtansine used alone to treat patients with FRα-positive ovarian cancer previously treated with 3-4 regimens and could potentially support an Accelerated Approval pathway. FORWARD II...


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