ImmunoGen, Inc. : Announces Presentation of New Clinical Data for SAR3419
06/04/2012| 12:05am US/Eastern
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).
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
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.
Carol Hausner, 781-895-0600
Director, Investor Relations and Corporate Communications
The Yates Network
Barbara Yates, 781-258-6153
© Business Wire 2012