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 10, 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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(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
November 10, 2006, ImmunoGen, Inc. (Nasdaq: IMGN) issued a press release to
announce the presentation of clinical data from a Phase I study evaluating
the
Company’s huN901-DM1 anticancer agent for the treatment of small-cell lung
cancer (SCLC) and other CD56-expressing solid tumors. HuN901-DM1 is the only
anticancer agent administered in the study and the compound has been found
to be
well-tolerated. Additionally, huN901-DM1 showed evidence of anticancer activity,
including one complete remission in a patient with recurrent Merkel cell cancer
and marked tumor shrinkage in a patient with relapsed SCLC. A primary objective
of the study is to determine the maximum tolerated dose (MTD) of huN901-DM1
when
administered for three days in a row every 21 days. The MTD is not yet defined
and enrollment continues.
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 10, 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 13, 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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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 10, 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
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For
Immediate
Release
ImmunoGen,
Inc.
Announces Presentation of HuN901-DM1 Clinical Data
At
EORTC-NCI-AACR
Conference Showing
Compound
is Well
Tolerated and Demonstrates Anticancer Activity
CAMBRIDGE,
MA,
November 10, 2006
- ImmunoGen, Inc.
(Nasdaq: IMGN) today announced the presentation of clinical data from a Phase
I
study evaluating the Company’s huN901-DM1 anticancer agent for the treatment of
small-cell lung cancer (SCLC) and other CD56-expressing solid tumors. The
compound has been found to be well-tolerated. Additionally, huN901-DM1 showed
evidence of anticancer activity, including one complete remission in a patient
with recurrent Merkel cell cancer and marked tumor shrinkage in a patient with
relapsed SCLC.
The
findings to date from this ongoing trial are being presented by Dr. Paul Lorigan
today at the EORTC-NCI-AACR International Conference on Molecular Targets and
Cancer Therapeutics (poster #649) in Prague, Czech Republic. Dr. Lorigan is
Senior Lecturer in Medical Oncology at the Christie Hospital in Manchester,
UK,
and the principal investigator in this trial. The study is designed to evaluate
huN901-DM1 when administered daily for three consecutive days in a 21-day cycle
to patients with relapsed or refractory SCLC or other CD56-expressing solid
tumors. HuN901-DM1 is the only anticancer agent administered in the
study.
“The
tolerability of huN901-DM1 compares favorably with that of other anticancer
agents,” commented Dr. Lorigan. “In particular, its lack of clinically
significant bone marrow toxicity means that huN901-DM1 can be studied in
combination with other anticancer agents if desired. And, while this trial
was
not designed to evaluate efficacy, promising clinical responses have been
reported.”
A
primary objective of the study is to determine the maximum tolerated dose (MTD)
of huN901-DM1 when administered for three days in a row every 21 days. To
establish the MTD, sequential new cohorts of patients receive increasing doses
of huN901-DM1 until dose-limiting toxicity is encountered. To date, eight dose
levels, ranging from 4 to 75 mg/m2/day
(12 to 225
mg/m2
over three days), have
been evaluated. The MTD is not yet defined and enrollment continues. Neither
clinically significant myelosuppression nor serious infusion reactions have
been
reported.
Response
information was
available for forty-one patients at the time of the poster presentation,
inclusive of the many patients treated at lower dose levels. Among the clinical
responses reported are:
| · |
A
patient with
recurrent, metastatic Merkel cell cancer has been in remission for
over a
year following treatment with huN901-DM1. This patient was diagnosed
with
Merkel cell cancer in late 2003 and underwent surgery, radiation therapy,
and chemotherapy, but her cancer returned in late 2004. She qualified
for
enrollment in this study, had a complete response to treatment, and
has
remained in clinical remission for 21
months.
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| · |
A
patient with
relapsed SCLC had an unconfirmed partial response after treatment with
huN901-DM1 at the 75 mg/m2/day
dose level.
Relapsed SCLC is a highly aggressive cancer that often fails to respond
to
subsequent treatments.
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| · |
13
patients had
stable disease following treatment with huN901-DM1. Two patients had
stable disease lasting about 18 weeks.
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1
About
huN901-DM1
ImmunoGen
developed
huN901-DM1 for the treatment of CD56-expressing cancers, including SCLC, other
cancers of neuroendocrine origin, and certain hematological malignancies
including multiple myeloma. The compound comprises the huN901 antibody, which
binds to the CD56 antigen, and DM1, a potent cell-killing agent developed by
ImmunoGen specifically for antibody-directed delivery to cancer cells. The
huN901 antibody is used to target the compound specifically to the cancer cells
and the DM1 serves to kill the cells.
ImmunoGen
has three
huN901-DM1 trials underway - a Phase II trial (Study 001) evaluating a weekly
dosing regimen in patients with relapsed SCLC, the trial reported today (Study
002), and a Phase I trial (Study 003) evaluating the compound in multiple
myeloma. Initial data have been reported from Studies 001 and 002, and the
Company will report the first data from Study 003 at the American Society of
Hematology (ASH) annual meeting in December 2006.
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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