ImmunoGen, Inc. Announces Presentation of New Clinical Data for SAR3419
June 03 2012 - 11:01PM
Business Wire
ImmunoGen, Inc. (Nasdaq: IMGN), a
biotechnology company, today announced the presentation of new
clinical data for the investigational compound, SAR3419, at the
American Society of Clinical Oncology (ASCO) annual meeting taking
place in Chicago, IL. SAR3419 uses ImmunoGen’s Targeted Antibody
Payload (TAP) technology and is a potential treatment for CD19+
non-Hodgkin’s lymphoma (NHL) and other B-cell malignancies. The
compound was created by ImmunoGen and licensed to Sanofi as part of
a broader collaboration. The data reported today are from the Phase
I evaluation that established the dosing schedule being used with
SAR3419 in its Phase II evaluation.
“We believe the findings reported today support that SAR3419 has
the potential to become an important new therapy for key B-cell
malignancies,” commented Daniel Junius, President and CEO. “These
findings also add to the growing body of clinical data supporting
that the utility of our TAP technology – and the depth of our
product opportunities – extend well beyond any one compound to
multiple types of cancers, antibodies, and product designs.”
In its Phase I assessment, SAR3419 has been found to demonstrate
activity across an array of NHL histological subtypes and in
patients with rituximab (Rituxan®)-refractory and -responsive
disease.1,2 Alternative dosing schedules were evaluated to
establish the recommended Phase II schedule.
The findings reported today (abstract #8057) are from an
extension of a weekly dosing Phase I trial. In this extension,
SAR3419 was administered weekly for four weeks and then on an every
two-week basis for another four doses. The study investigators note
that this schedule “demonstrates an improved safety profile
compared to prior tested schedules” while preserving antitumor
activity:
- When dosed weekly (at 55 mg/m2), 33%
(7/21) of patients had an objective response (a complete
response/CR or partial response/PR).
- When the same dose level was
administered with this modified schedule, 29% (6/21) of patients
had an objective response and another 43% (9/21) had stable
disease.
In October 2011, Sanofi advanced SAR3419 into Phase II clinical
testing. In Phase II, the compound is being evaluated for the
treatment of CD19+ diffuse large B-cell lymphoma (DLBCL) – alone
and in combination with rituximab – and for B-cell acute
lymphoblastic leukemia (B-ALL).
About SAR3419
SAR3419 is an investigational TAP compound that consists of a
CD19-binding antibody developed by ImmunoGen with one of the
Company’s potent cell-killing agents, DM4, attached using one of
its engineered linkers. The antibody enables the compound to bind
specifically to cancer cells expressing its CD19 target and the DM4
serves to kill these cells.
About ImmunoGen, Inc.
ImmunoGen, Inc. develops targeted anticancer therapeutics using
the Company's expertise in tumor biology, monoclonal antibodies,
potent cancer-cell killing agents and engineered linkers. The
Company's TAP technology uses monoclonal antibodies to deliver one
of ImmunoGen's proprietary cancer-cell killing agents specifically
to tumor cells. There are now numerous TAP compounds in clinical
development with a wealth of clinical data reported. ImmunoGen's
collaborative partners include Amgen, Bayer HealthCare, Biotest,
Lilly, Novartis, Roche and Sanofi. The most advanced compound using
ImmunoGen's TAP technology, trastuzumab emtansine (T-DM1), is in
Phase III testing through the Company's collaboration with
Genentech, a member of the Roche Group. More information about
ImmunoGen can be found at www.immunogen.com.
1Younes, A. et al., ASH, Dec. 2009
2Coiffer B. et al., 11th International conference on Malignant
Lymphoma, June 2011
Rituxan® is a registered trademark of Biogen Idec.
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 SAR3419, including risks
related to clinical studies and their results. A review of these
risks can be found in ImmunoGen's Annual Report on Form 10-K for
the fiscal year ended June 30, 2011 and other reports filed with
the Securities and Exchange Commission.
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