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): December 15, 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)
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(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
December 15, 2006, ImmunoGen, Inc. (Nasdaq: IMGN) issued a press
release to
announce the presentation of the initial findings from a Phase I clinical study
that evaluates Genentech’s trastuzumab-MCC-DM1 for the treatment of
HER2-positive metastatic breast cancer. Trastuzumab-MCC-DM1 is being developed
by Genentech and uses ImmunoGen’s TAP technology. The compound comprises
Genentech’s trastuzumab anti-HER2 antibody and ImmunoGen’s DM1 cell-killing
agent. The findings presented are from the first seven patients in an ongoing
Phase I trial designed to assess the safety, tolerability and pharmacokinetics
of
trastuzumab-MCC-DM1 given every three weeks to patients with HER2-positive
metastatic breast cancer.
ITEM
9.01.
FINANCIAL STATEMENTS AND EXHIBITS
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Exhibit
No.
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Exhibit
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99.1
|
Press
Release of
ImmunoGen, Inc. dated December 15, 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:
December 15, 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 December 15, 2006
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4
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
First
Clinical
Data for Genentech’s Trastuzumab-MCC-DM1
CAMBRIDGE,
MA, December 15, 2006
- ImmunoGen, Inc.
(Nasdaq: IMGN) announced the presentation today of the initial findings from
a
Phase I clinical study that evaluates Genentech’s trastuzumab-MCC-DM1 for the
treatment of HER2-positive metastatic breast cancer. Trastuzumab-MCC-DM1 is
being developed by Genentech and uses ImmunoGen’s Tumor-Activated Prodrug (TAP)
technology. The compound comprises Genentech’s trastuzumab anti-HER2 antibody
and ImmunoGen’s DM1 cell-killing agent. ImmunoGen’s TAP technology uses
tumor-targeting antibodies to deliver a potent cell-killing agent specifically
to cancer cells.
“We’re
delighted with the clinical findings with trastuzumab-MCC-DM1 being reported
today,” commented Mitchel Sayare, ImmunoGen Chairman and CEO. “A primary reason
we outlicense our technology to other companies is to enable the development
of
TAP compounds to antibody targets beyond those available for our own product
programs, thus broadening the pool of cancer patients who potentially may
benefit from our technology.”
The
poster is being presented at the 29th Annual San Antonio Breast Cancer Symposium
taking place in San Antonio, TX. The presentation is being made by Howard
Burris, MD, of the Sarah Cannon Research Institute in Nashville,
TN.
The
findings presented are from the first seven patients in an ongoing Phase I
trial
designed to assess the safety, tolerability and pharmacokinetics of
trastuzumab-MCC-DM1 given every three weeks to patients with HER2-positive
metastatic breast cancer. To qualify for enrollment, patients must have
incurable, locally advanced or metastatic breast cancer and must have progressed
on a chemotherapy regimen containing trastuzumab (Herceptin®).
Increasing doses of
trastuzumab-MCC-DM1 are given to new patients until the maximum tolerated dose
(MTD) is established.
The
highest two dose levels that have been evaluated are 2.4 mg/kg and
4.8 mg/kg. The patient receiving the 2.4 mg/kg dose level had an objective
partial response (PR) by RECIST criteria.
1
Dose
limiting but rapidly reversible thrombocytopenia was observed in the patient
treated at the 4.8 mg/kg dose level. No cardiac toxicity was observed in the
seven study patients to date. Enrollment is ongoing to define the MTD for
trastuzumab-MCC-DM1 when administered on a three-week schedule.
About
ImmunoGen,
Inc.
ImmunoGen,
Inc. develops
targeted anticancer biopharmaceuticals. The Company’s proprietary 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-MCC-DM1, in development by Genentech. Amgen
(formerly Abgenix), Biogen Idec, Biotest AG, Boehringer Ingelheim, Centocor,
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 development of products by our
collaborators, as well as to the Company’s development of its own 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.
Herceptin®
is
a registered
trademark of Genentech.
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