ImmunoGen, Inc. Announces Presentation of Favorable SAR3419 Interim Clinical Data at ASCO
June 04 2011 - 8:00AM
Business Wire
ImmunoGen, Inc. (Nasdaq: IMGN), a
biotechnology company that develops targeted antibody-based
anticancer products using its antibody expertise and Targeted
Antibody Payload (TAP) technology, today announced the presentation
of favorable clinical data for SAR3419 in the treatment of B-cell
non-Hodgkin’s lymphoma (NHL). These data were presented at the ASCO
2011 Annual Meeting taking place in Chicago, IL. SAR3419, which
uses the Company’s TAP technology, was initially developed by
ImmunoGen and licensed to Sanofi preclinically as part of a broader
collaboration.
“We believe the promising SAR3419 clinical data presented today
further validate our TAP technology and the potential of our deep
pipeline,” said Daniel Junius, President and CEO. “SAR3419 has
shown impressive efficacy and tolerability in the heavily
pretreated patients enrolled in this study, half of whom were
refractory to rituximab. Sanofi plans to aggressively develop
SAR3419, starting with advancing it into Phase II testing later
this year.”
In the trial reported today, patients received SAR3419 dosed
weekly for eight weeks, with longer treatment possible. New cohorts
of patients received increasingly greater doses of SAR3419 until
its maximum tolerated dose (MTD) was defined. Additional patients
were treated with SAR3419 at this MTD in the expansion phase of the
trial.
The encouraging clinical data presented today included:
- 33% (7/21) of patients treated with
SAR3419 at its MTD (55 mg/m2/week) had an objective response
(CR/PR).
- The duration of responses has ranged
from five weeks to at least 55 weeks, with three patients still
responding at the time of data cut-off for presentation.
- Among patients who received any dose
level of SAR3419 for whom histological data was available, tumor
shrinkage of more than 20% was reported in:
- 50% (8/16) of patients with diffuse
large B-cell lymphoma;
- 46% (7/15) of patients with follicular
lymphoma; and
- 50% (2/4) of patients with mantle cell
lymphoma.
- Benefit was seen with both indolent and
aggressive NHL.
- SAR3419 is well tolerated. Of
particular note is the lack of significant myelosuppression
associated with SAR3419 treatment, which is appealing for use in
combination with standard chemotherapy agents.
It was identified that further improvement in the tolerability
of SAR3419 might be achieved by switching to a bi-weekly dosing
regimen after steady state pharmacokinetics were achieved, as some
toxicities occurred only after 6-8 treatment cycles (e.g., the one
case of Grade 3 ocular toxicity reported, which was reversible).
Following protocol amendment, SAR3419 is now being evaluated dosed
weekly for 4 weeks followed by dosing every other week for another
4 doses.
About the Clinical Trial
The data reported today are from an ongoing Phase I trial in
patients with relapsed or relapsed/refractory CD19-expressing
B-cell non-Hodgkin’s lymphoma. Almost all of the patients were
categorized as having stage III or IV lymphoma at study entry. The
patients had received a median of three prior treatment regimens,
and about half of the patients had rituximab-resistant disease.
Nineteen of the forty-four patients enrolled had previously
received a stem cell transplant. The SAR3419 doses evaluated ranged
from 10-70 mg/m2/week.
Additional data from this trial will be presented at the
International Conference on Malignant Lymphoma meeting in Lugano,
Switzerland later this month.
About SAR3419
SAR3419 was developed by ImmunoGen and licensed to Sanofi as
part of a broader collaboration. It consists of a CD19-targeting
antibody developed by ImmunoGen with the Company’s DM4 cell-killing
agent attached using one of ImmunoGen’s engineered linkers.
About B-cell Non-Hodgkin’s Lymphoma
B-cell lymphomas comprise approximately 85% of non-Hodgkin’s
lymphomas in the United States and account for about 4% of all
cancers. In 2010, over 65,000 people will be diagnosed with NHL and
20,000 people will die from it. The 5-year survival rate for this
disease is around 67%.1
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 currently six TAP compounds in the
clinic, with a wealth of clinical data reported with the
technology. ImmunoGen’s collaborative partners include Amgen, Bayer
HealthCare Pharmaceuticals, Biotest, Genentech (a member of the
Roche Group), Novartis, 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. More information about ImmunoGen can be found at
www.immunogen.com.
1 American Cancer Society, Detailed Guide: What is Non-Hodgkin’s
Lymphoma
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 in the Company’s and its collaboration
partners’ product programs, including SAR3419, including risks
related to uncertainties around clinical studies and 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 June 30, 2010
and other reports filed with the Securities and Exchange
Commission.
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