ImmunoGen, Inc. Announces Presentation of Encouraging Clinical Data for IMGN388 at EORTC-NCI-AACR Symposium on Molecular Targ...
November 19 2010 - 6:31AM
Business Wire
ImmunoGen, Inc. (Nasdaq: IMGN), a
biotechnology company that develops antibody-based anticancer
products using its Targeted Antibody Payload (TAP) technology,
today announced the presentation of encouraging clinical data for
the Company’s IMGN388 anticancer compound at the
22nd EORTC-NCI-AACR Symposium on Molecular Targets and Cancer
Therapeutics taking place in Berlin, Germany.
IMGN388, a TAP compound, is designed to target and kill cells
that express its αv integrin target. This antigen is found on
a number of types of solid tumors, including lung, breast and
prostate cancers. It is also found on vascular cells in the process
of forming new blood vessels, a process that needs to occur for any
solid tumor to grow.
The poster presentation, entitled “A Phase I Study of IMGN388,
an Antibody Drug Conjugate Targeting αv Integrin, in Patients with
Solid Tumors,” reports findings from the trial’s dose-finding
phase, which was designed to determine the maximum tolerated dose
of the compound when administered once every three weeks. In this
phase, IMGN388 was found to be well tolerated at doses up to and
including 130 mg/m2 (3.5 mg/kg).
Initial evidence of activity also was reported, with four
patients remaining on IMGN388 for 18 weeks or longer before disease
progression. All but one of these patients was on IMGN388 longer
than their last prior therapy. Two of these patients have received
the compound for over 30 weeks and were still benefiting from
treatment at the time of data analysis for the presentation.
“IMGN388 was well tolerated at doses at which evidence of
anticancer activity was observed,” commented James O’Leary, MD,
Vice President and Chief Medical Officer. “Based on the
tolerability of the compound and its pharmacokinetic profile, our
next step will be to evaluate IMGN388 when administered on a more
frequent basis.”
About the Study
The data reported are from the first trial conducted with
IMGN388. In the dose-finding phase of the study, new cohorts of
patients received increasing doses of the compound to establish its
maximum tolerated dose when administered once every three weeks.
Patients enrolled in this phase were required to have advanced
solid tumors, but it was not required that their tumor(s) express
αv integrin. In the poster presented, thirty-eight patients
had received one of ten different dose levels ranging from 5-160
mg/m².
Of the four patients remaining on IMGN388 for 18 weeks or
longer, two had non-small cell lung cancer (NSCLC), one had
prostate cancer, and one had a carcinoid tumor. One of the patients
with NSCLC has been on study for over 32 weeks, and the patient
with the carcinoid tumor has been on study for over 38 weeks. Both
of these patients received IMGN388 at one of the higher doses
evaluated (105 mg/m2).
The study protocol is now being amended to evaluate IMGN388 when
administered weekly for two weeks (Day 1 and Day 8) in a 3-week
cycle.
About ImmunoGen, Inc.
ImmunoGen, Inc. develops targeted anticancer therapeutics using
the Company's expertise in tumor biology, monoclonal antibodies and
potent cancer-cell killing agents. 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 seven TAP compounds in the clinic, with a
wealth of clinical data reported with the technology. ImmunoGen’s
collaborative partners include Amgen, Bayer Schering Pharma, Biogen
Idec, Biotest, Genentech (a member of the Roche Group), Novartis,
and sanofi-aventis. The most advanced compound using ImmunoGen's
TAP technology, trastuzumab-DM1 (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.
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 IMGN388, including risks
related to uncertainties around clinical trials conducted 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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