ImmunoGen, Inc. Announces 2015 Outlook for Product Pipeline
"We expect the potential of ImmunoGen as a product company to become
more clearly established in 2015, principally based on progress with our
lead experimental therapies - IMGN853 for ovarian and endometrial
cancers and IMGN529 for diffuse large B-cell lymphoma and other B-cell
malignancies," commented
Wholly Owned Product Candidates
IMGN853 - the first and only folate receptor α (FRα)-targeting ADC to advance to clinical testing.
- Current stage: In Phase Ib efficacy testing for the treatment of FRα-positive platinum-resistant ovarian cancer and relapsed/refractory endometrial cancer, administered on Day 1 in a 3-week cycle. Also in dose-finding testing administered on Days 1, 8, and 15 in a 4-week cycle.
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Expected 2015 events include:
- Presentation of updated clinical findings - 2Q2015.
- Initiation of Phase II testing in FRα-positive ovarian cancer or endometrial cancer, or both, with potential for accelerated registration program(s) if the data allow - 2H2015.
- Initiation of assessment in combination regimens for the treatment of FRα-positive ovarian cancer.
IMGN529 - the first ADC for B-cell malignancies with an antibody demonstrating potent anticancer activity preclinically, and the first to target CD37.
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Current stage: in dose-finding Phase I clinical trial, with
data presented at the December annual meeting of the
American Society of Hematology (ASH). -
Expected 2015 events include:
- Selection of recommended Phase II dose - 1H2015.
- Start of initial efficacy testing, including as a treatment for relapsed/refractory diffuse large B-cell lymphoma and for chronic lymphocytic leukemia - 2Q/3Q2015.
- Presentation of updated clinical data - 2H2015.
IMGN289 - the first EGFR-targeting ADC with an antibody demonstrating potent anticancer activity preclinically.
- Current stage and 2015 expectations: in dose-finding Phase I clinical testing for the treatment of EGFR-positive solid tumors.
IMGN779 - the first ADC utilizing one of ImmunoGen's new DNA-acting payload agents.
- Current stage: preclinical.
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Expected 2015 events include:
- Submission of Investigational New Drug Application (IND) - 2H2015.
Partner Compounds
ImmunoGen partners include Amgen,
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Based on its disclosures, Roche's expected 2015 Kadcyla
(ado-trastuzumab emtansine) events include:
- For 2nd-line treatment of advanced, HER2-positive gastric cancer - presentation of data from GATSBY trial, and - if positive - submission for marketing approval.
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For 1st-line treatment of advanced, HER2-positive breast cancer -
presentation of data from
MARIANNE trial; discussion with regulatory authorities.
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In addition to Kadcyla, 8 other compounds are in clinical testing
through ImmunoGen partnerships: AMG 172, AMG 595, BAY 94-9343, BT-062,
SAR650984 ,SAR3419 ,SAR566658 , andSAR408701 . ImmunoGen expects clinical data disclosures and development events for several of these compounds. -
ImmunoGen expects non-clinical data disclosures for multiple partner
compounds at the
American Association for Cancer Research (AACR) annual meeting inApril 2015 . - ImmunoGen expects 3-4 additional partner compounds to advance into clinical testing in 2015.
Cash Position
ImmunoGen will report the financial results on
About
Kadcyla® is a registered trademark of
This press release includes forward-looking statements. For these
statements, ImmunoGen claims the protection of the safe harbor for
forward-looking statements provided by the Private Securities Litigation
Reform Act of 1995. It should be noted that there are risks and
uncertainties related to the development of novel anticancer products,
including ImmunoGen wholly owned and partner compounds, including risks
related to preclinical testing, clinical studies and regulatory
interactions, their timings and results. A review of these risks can be
found in ImmunoGen's Annual Report on Form 10-K for the fiscal year
ended
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