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 11, 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
December 11, 2006, ImmunoGen, Inc. (Nasdaq: IMGN) issued a press release to
announce the presentation of initial findings from a Phase I study evaluating
the Company’s huN901-DM1 TAP compound for the treatment of multiple myeloma at
the annual meeting of the American Society of Hematology (ASH) in Orlando,
FL.
This Phase I study is designed to evaluate huN901-DM1 for the treatment of
relapsed multiple myeloma. To qualify for enrollment, patients must have
relapsed or relapsed/refractory multiple myeloma that expresses the CD56-antigen
targeted by huN901-DM1; approximately 70% of multiple myeloma cases express
this
antigen. The initial findings show evidence of anticancer activity among the
three patients receiving the higher of the two huN901-DM1 dose levels evaluated
to date.
ImmunoGen
also disclosed
progress with the TAP compound, AVE9633, which is in development by
sanofi-aventis for the treatment of acute myeloid leukemia (AML). The favorable
tolerability profile of AVE9633 demonstrated in this first trial enables the
compound to be evaluated in additional Phase I studies with a more frequent
dosing schedule better suited to the highly proliferative nature of AML. A
second Phase I study is underway in Europe.
The
Company’s TAP technology uses tumor-targeting antibodies to deliver a potent
cell-killing agent specifically to cancer cells.
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 December 11, 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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|||
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(Registrant)
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Date:
December 11, 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 11, 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 at ASH of
Encouraging
Findings with HuN901-DM1 for the Treatment of Multiple Myeloma
-
The
Company Also Announces Progress with AVE9633 for Acute Myeloid Leukemia
-
CAMBRIDGE,
MA,
December 11, 2006
- ImmunoGen, Inc.
(Nasdaq: IMGN) announced the presentation today of encouraging initial findings
from a Phase I study evaluating the Company’s huN901-DM1 Tumor-Activated Prodrug
(TAP) compound for the treatment of multiple myeloma at the annual meeting
of
the American Society of Hematology (ASH) in Orlando, FL. These initial findings
show evidence of anticancer activity among the patients receiving the higher
of
the two huN901-DM1 dose levels evaluated to date. ImmunoGen also announced
progress with the TAP compound, AVE9633, which is in development by
sanofi-aventis for the treatment of acute myeloid leukemia (AML). The Company’s
TAP technology uses tumor-targeting antibodies to deliver a potent cell-killing
agent specifically to cancer cells.
HuN901-DM1
Clinical Findings Reported at ASH
The
findings to date from this ongoing trial are being presented today (poster
#3574) by Asher Chanan-Khan, MD, of the Roswell Park Cancer Institute in
Buffalo, NY. This Phase I study is designed to evaluate huN901-DM1 for the
treatment of relapsed multiple myeloma. To qualify for enrollment, patients
must
have relapsed or relapsed/refractory multiple myeloma that expresses the
CD56-antigen targeted by huN901-DM1; approximately 70% of multiple myeloma
cases
express this antigen. All of the patients enrolled to date received four or
more
chemotherapeutic regimens prior to entering the study. HuN901-DM1 is the only
anticancer agent administered during this trial.
In
this study, huN901-DM1 is administered weekly for two consecutive weeks in
a
three-week cycle. A primary objective of the trial is to determine the maximum
tolerated dose (MTD) of huN901-DM1 in multiple myeloma patients with this dosing
schedule. To establish the MTD, sequential new cohorts of patients receive
increasing doses of huN901-DM1 until dose-limiting toxicity is encountered.
Two
huN901-DM1 dose levels had been evaluated at the time of the ASH meeting:
40 mg/m2/day
and
60 mg/m2/day.
The MTD has not yet
been defined and patient enrollment continues.
Evidence
of antitumor
activity was reported among the small group of patients receiving the higher
of
the two dose levels evaluated to date. One of the three patients receiving
the
60 mg/m2/day
dose had a minimal
objective response by European Bone Marrow Transplant (EBMT) criteria. This
patient had a 39% reduction in her serum M component, a disappearance of her
urine M component, and no evidence of disease progression in her skeleton or
bone marrow. She had previously been treated with thalidomide, lenalidomide,
multiple chemotherapy regimens, and radiation therapy. To date, this patient
has
received 12 cycles of treatment with huN901-DM1 (24 doses over 36 weeks).
Another of the three patients receiving 60 mg/m2/day
remained on treatment
for five cycles, and the most recently enrolled patient has had stable disease
for at least two cycles and continues to receive huN901-DM1.
1
Robert
J. Fram, MD, Vice President, Clinical Development, commented, “These findings,
while preliminary, are very encouraging. HuN901-DM1 has been well tolerated
and
a patient who failed multiple prior therapies had an objective response at
the
higher of the two doses evaluated to date.”
HuN901-DM1
is designed to
target and kill CD56-expressing cancer cells. The compound comprises the
CD56-targeting antibody, huN901, and the potent cell-killing agent, DM1. Its
antibody component serves to target the compound specifically to the cancer
cells and its DM1 component functions to kill the cancer cells. Targeting of
huN901-DM1 to the myeloma cells in the marrow was confirmed in this study using
immunohistochemistry. There have been no reports of clinically significant
myelosuppression with huN901-DM1 either in this study or in the two studies
underway that evaluate the compound for the treatment of small-cell lung cancer
and other CD56-expressing solid tumors.
Clinical
Progress
with AVE9633
Findings
were published in
an abstract (abstract #4548) to the ASH meeting on a second TAP compound,
AVE9633, in development for the treatment of a hematological malignancy. This
compound comprises the CD33-targeting antibody, huMy9-6, and the potent
cell-killing agent, DM4, and is in Phase I clinical testing for the treatment
of
AML. AVE9633 was developed by ImmunoGen and licensed to sanofi-aventis, which
is
responsible for the clinical development of the compound.
The
findings are from the first Phase I trial initiated with AVE9633. In this trial,
the compound was dosed once per three weeks to provide information on the safety
and pharmacokinetics of single administrations of AVE9633. The compound was
found to be well tolerated: doses up to 260 mg/m2
were administered without
dose-limiting toxicity.
The
favorable tolerability profile of AVE9633 demonstrated in this first trial
enables the compound to be evaluated in additional Phase I studies with a more
frequent dosing schedule better suited to the highly proliferative nature of
AML. A study evaluating AVE9633 when dosed weekly for two consecutive weeks
in a
four-week cycle is underway
in Europe. While
data from the European Phase I study have not yet been reported, to date they
are encouraging.
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-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 Company’s development of its own
products, as well as to the development of products by our collaborators. 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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