UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C.
20549
FORM
8-K
CURRENT
REPORT
PURSUANT
TO
SECTION 13 OR 15(d)
OF
THE SECURITIES
EXCHANGE ACT OF 1934
Date
of
Report (Date of earliest event reported): November 8, 2006
ImmunoGen,
Inc.
(Exact
name of registrant as specified in its charter)
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Massachusetts
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0-17999
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04-2726691
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||
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(State
or other
jurisdiction of incorporation)
|
(Commission
File
Number)
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(IRS
Employer
Identification No.)
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128
Sidney Street,
Cambridge, MA 02139
(Address
of principal
executive offices) (Zip Code)
Registrant's
telephone
number, including area code: (617)
995-2500
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions (see
General
Instruction A.2.
below):
o Written
communications
pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting
material
pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
o Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
ITEM
8.01 - OTHER
EVENTS
On
November 8, 2006, ImmunoGen, Inc. (Nasdaq: IMGN) issued a press release to
announce the presentation of initial clinical data from an ongoing Phase I
study
evaluating the Company’s huC242-DM4 compound for the treatment of colorectal,
pancreatic, gastric and other CanAg-expressing cancers. The study is designed
primarily to establish the dose limiting toxicities (DLT) and maximum tolerated
dose (MTD) of huC242-DM4 when administered once per three weeks to patients
with
recurrent CanAg-expressing cancers. To date, patients have received eight
different dose levels, ranging from 18 to 297 mg/m2.
The MTD has not been
established and recruitment is ongoing. Twenty-eight patients have received
at
least one dose of the compound, with no reports of clinically significant
myelosuppression.
ITEM
9.01.
FINANCIAL STATEMENTS AND EXHIBITS
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Exhibit
No.
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Exhibit
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99.1
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Press
Release of
ImmunoGen, Inc. dated November 8, 2006
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2
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant
has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
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ImmunoGen,
Inc.
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(Registrant)
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Date:
November 8, 2006
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/s/
Daniel M. Junius
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Daniel
M. Junius
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Executive
Vice President and Chief Financial Officer
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3
EXHIBIT
INDEX
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Exhibit
No.
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Exhibit
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99.1
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Press
Release of
ImmunoGen, Inc. dated November 8, 2006
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4
Exhibit
99.1
128
Sidney Street, Cambridge, MA 02139-4239 TEL:
(617) 995-2500 FAX:
(617) 995-2510
Contacts:
|
Investors
Carol
Hausner
Executive
Director,
Investor Relations and
Corporate
Communications
Tel:
(617) 995-2500
info@immunogen.com
|
Media
Kathryn
Morris
KMorrisPR
(845)
635-9828
Kathryn@kmorrispr.com
|
For
Immediate
Release
ImmunoGen,
Inc.
Announces Presentation of HuC242-DM4
Clinical
Data at
EORTC-NCI-AACR Conference
CAMBRIDGE,
MA,
November 8, 2006
- ImmunoGen, Inc.
(Nasdaq: IMGN) today announced the presentation of initial clinical data from
an
ongoing Phase I study evaluating the Company’s huC242-DM4 compound for the
treatment of colorectal, pancreatic, gastric and other CanAg-expressing cancers.
This
trial is being conducted at the Cancer Therapy and Research Center (CTRC) in
San
Antonio, TX. Anthony W. Tolcher, MD - the Principal Investigator - is presenting
the findings to date at the EORTC-NCI-AACR International Conference on Molecular
Targets and Cancer Therapeutics (poster #212) today in Prague, Czech Republic.
The study is designed primarily to establish the dose limiting toxicities (DLT)
and maximum tolerated dose (MTD) of huC242-DM4 when administered once per three
weeks to patients with recurrent CanAg-expressing cancers.
Dr.
Tolcher commented, “The tolerability of huC242-DM4 compares favorably with
ImmunoGen’s earlier CanAg-targeting compound, cantuzumab mertansine, even though
the patients in this study have received a greater number of prior therapies.”
To
qualify for enrollment, patients need to have inoperable or metastatic
CanAg-expressing cancer that has failed treatment with standard therapy. Almost
all of the study patients have received at least four prior chemotherapy
regimens and most of the patients have colon cancer. To establish the MTD,
sequential new cohorts of patients are given increasingly greater doses of
huC242-DM4 until DLT is encountered. Patients with diverse levels of CanAg
expression are eligible for enrollment until the MTD is established. At that
point, only patients with strong, homogenous expression of CanAg will be
enrolled.
To
date, patients have received eight different dose levels, ranging from 18 to
297
mg/m2.
The MTD has not been
established and recruitment is ongoing. Twenty-eight patients have received
at
least one dose of the compound, with no reports of clinically significant
myelosuppression.
1
The
half life of huC242-DM4 has been found to be about five days in patients with
low levels of the CanAg antigen present in their blood, as compared with the
two-day half life reported with cantuzumab mertansine. Consequently, exposure
to
huC242-DM4 is more sustained than that achieved with an equivalent amount of
cantuzumab mertansine in comparable patients. High blood levels of shed CanAg
have been found to increase the rate of clearance of the huC242 antibody and
of
huC242-DM4, but do not significantly affect the peak concentration (Cmax) of
the
compound.
About
huC242-DM4
ImmunoGen
developed
huC242-DM4 for the treatment of cancers expressing the CanAg antigen. These
include colorectal, pancreatic, and other gastrointestinal cancers as well
as
many non-small cell lung cancers. HuC242-DM4 comprises the huC242 antibody,
which binds to CanAg, and DM4, a potent cell-killing agent developed by
ImmunoGen specifically for antibody-directed delivery to cancer cells. The
huC242 antibody functions to target the compound specifically to the cancer
cells and the DM4 serves to kill the cells.
An
earlier compound containing the huC242 antibody, cantuzumab mertansine, was
evaluated in initial clinical testing. It was found to have an MTD of 235
mg/m2
when administered once
every three weeks.
About
ImmunoGen,
Inc.
ImmunoGen,
Inc. develops
targeted anticancer biopharmaceuticals. The Company’s proprietary
Tumor-Activated Prodrug (TAP) technology uses tumor-targeting antibodies to
deliver a potent cell-killing agent specifically to cancer cells. Five
anticancer compounds are in clinical testing through ImmunoGen and the Company’s
collaborators - huN901-DM1 and huC242-DM4, which are wholly owned by ImmunoGen,
AVE9633 and AVE1642, in development by sanofi-aventis, and trastuzumab-DM1,
in
development by Genentech. Amgen (formerly Abgenix), Biogen Idec, Biotest AG,
Boehringer Ingelheim, Centocor (Johnson & Johnson), Genentech, Millennium
Pharmaceuticals, Inc., and sanofi-aventis have licensed the right to develop
and/or test TAP compounds to specific targets; ImmunoGen also has a broader
collaboration with sanofi-aventis.
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 Company’s development of its own
products as well as to the development of collaboration products. A review
of
these risks can be found in ImmunoGen’s Annual Report on Form 10-K for the
fiscal year ended June 30, 2006 and other reports filed with the Securities
and
Exchange Commission.
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