ImmunoGen, Inc. Announces Encouraging IMGN388 Clinical Data Reported at ASCO
June 07 2010 - 8:02AM
Business Wire
ImmunoGen, Inc. (Nasdaq: IMGN), a biopharmaceutical company that
develops targeted anticancer therapeutics, today announced the
presentation of the first clinical data for the Company’s IMGN388
anticancer compound at the 2010 Annual Meeting of the American
Society of Clinical Oncology (ASCO) being held in Chicago, IL. In
this dose-escalation trial, IMGN388 has demonstrated favorable
tolerability at the dose levels evaluated to date, and evidence of
activity is being reported now that higher doses are starting to be
evaluated. Dose escalation is continuing.
“We’re encouraged by the clinical findings with IMGN388,”
commented James O’Leary, MD, Vice President and Chief Medical
Officer. “It’s been well tolerated at the doses evaluated to date.
This has enabled rapid advancement to dose levels where we’d expect
to begin seeing evidence of activity and that has started to occur.
We’re using this trial to inform the next steps in IMGN388’s
development, which we expect to include its assessment as part of a
combination regimen and potentially in specific types of
cancer.”
IMGN388
IMGN388 is in development by ImmunoGen for the treatment of
solid tumors. It utilizes the Company’s Targeted Antibody Payload
(TAP) technology and consists of ImmunoGen’s DM4 cancer-cell
killing agent attached to an αv integrin-targeting antibody
using the Company’s method of attachment. The antibody component
serves to target IMGN388 to αv integrin-expressing cells and
the DM4 serves to kill these cells. The compound’s integrin target
is expressed on a wide variety of solid tumors and also on
endothelial cells in the process of forming new blood vessels
(angiogenesis), a process that needs to occur in order for solid
tumors to grow.
Clinical Data Reported
The data reported today (Abstract #3058) are from the first
clinical trial to be conducted with IMGN388. In the dose-escalation
phase of this trial, patients with any type of solid tumor are
eligible for enrollment. Once the maximum tolerated dose has been
established, enrollment will be limited to patients with solid
tumors confirmed to express its αv integrin target. To date,
doses ranging from 5 to 130 mg/m2 have been evaluated, IMGN388
has been found to be well tolerated, and dose escalation is
continuing.
The evidence of activity reported is increasing with escalating
dose levels:
- Among patients receiving 5, 10,
20 or 30 mg/m2 – no evidence of activity;
- Among patients receiving 45 or
60 mg/m2 – one patient at each dose level had stable disease
lasting for up to 6 treatment cycles (18 weeks); and
- Among patients receiving 80 or
105 mg/m2 – four of these six patients had stable disease. This
response was ongoing in two patients at the time of the
presentation and had been sustained for at least 7 treatment cycles
(21 weeks) in one of these patients.
All of the patients treated with 130 mg/m2 were still on study,
but had not been followed for sufficient time for inclusion in the
efficacy analysis.
The responses to IMGN388 occurred in an array of tumor types –
non-small cell lung cancer (two patients) and in prostate, breast,
neuroendocrine and uterine cancer. All of these patients had
relapsed disease.
About ImmunoGen’s Targeted Antibody Payload (TAP)
Technology
The Company’s TAP technology uses manufactured antibodies to
deliver one of ImmunoGen’s highly potent cancer-cell killing agents
(e.g., DM1, DM4) specifically to tumors. The Company’s cancer-cell
killing agents are many-fold more potent than standard
chemotherapeutics and were developed by ImmunoGen scientists
specifically for targeted delivery to tumors. ImmunoGen has also
engineered linkage technology that keeps the cancer-cell killing
agent attached to the antibody until it reaches the cancer cell and
then controls the release of the agent inside the cell. In addition
to IMGN388, five other compounds that make use of ImmunoGen’s TAP
technology are in clinical testing.
About ImmunoGen, Inc.
ImmunoGen, Inc. develops targeted anticancer therapeutics using
its expertise in cancer biology, monoclonal antibodies and the
creation and attachment of potent cancer-cell killing agents. The
Company’s TAP technology uses antibodies to deliver one of
ImmunoGen’s highly potent cancer-cell killing agents specifically
to tumors. In addition to the Company’s product pipeline, compounds
utilizing the TAP technology are in clinical testing through
ImmunoGen’s collaborations with Genentech (a wholly owned member of
the Roche Group), sanofi-aventis, Biogen Idec and Biotest. The most
advanced compound, trastuzumab-DM1 (T-DM1), is in Phase III
testing being conducted by Genentech and Roche. Other ImmunoGen
collaborative partners include Bayer Schering Pharma and Amgen.
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, that include 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, 2009 and other reports filed with the Securities and
Exchange Commission.
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