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 16, 2005
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
November 16, 2005, ImmunoGen, Inc. (Nasdaq: IMGN) issued a press release to
announced the presentation of encouraging clinical findings with the Company’s
huN901-DM1 Tumor-Activated Prodrug (TAP) compound at the AACR-NCI-EORTC
International Conference on Molecular Targets and Cancer Therapeutics underway
in Philadelphia, PA. Clinical activity seen with huN901-DM1 in this study
includes a complete remission lasting at least 15 weeks and stable disease
lasting up to 18 weeks.
A
copy of
the press release is attached to this current report on Form 8-K as Exhibit
99.1.
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 16,
2005
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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 16, 2005
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/s/
Karleen M. Oberton
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Karleen
M. Oberton
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Senior
Corporate Controller
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(Principal
Accounting Officer)
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3
Exhibit
99.1
128
Sidney Street, Cambridge, MA 02139-4239 &
#160; 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
Tony
Loke
Rx
Communications Group, LLC
Tel:
(917) 322-2164
tloke@rxir.com
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For
Immediate Release
ImmunoGen,
Inc. Announces Presentation of HuN901-DM1 Clinical Data
at
the AACR-NCI-EORTC International Conference on
Molecular
Targets and Cancer Therapeutics
-
Clinical
Activity Reported Includes Sustained Complete Remission and Stable
Disease
-
CAMBRIDGE,
MA, November 16, 2005
-
ImmunoGen, Inc. (Nasdaq: IMGN) today announced the presentation of encouraging
clinical findings with the Company’s huN901-DM1 Tumor-Activated Prodrug (TAP)
compound at the AACR-NCI-EORTC International Conference on Molecular Targets
and
Cancer Therapeutics underway in Philadelphia, PA. As reported today, clinical
activity seen with huN901-DM1 in this study includes a complete remission
lasting at least 15 weeks and stable disease lasting up to 18
weeks.
Today’s
poster presentation (#B97) features the first data to be reported from this
on-going Phase I clinical trial evaluating huN901-DM1 when administered daily
for three consecutive days in a 21-day cycle to patients with CD56-expressing
solid tumors. In this dose-escalation study, new cohorts of patients receive
progressively higher doses of huN901-DM1 until the maximum tolerated dose
is
established. All study patients have relapsed or refractory small-cell lung
cancer (SCLC) or other CD56-expressing solid tumors. HuN901-DM1 is the only
anticancer agent administered.
A
sustained complete remission was reported with one of the four patients treated
at a dose level of 36 mg/m2/day
(108
mg/m2
over
three consecutive days) or higher for which response information is available.
This patient was diagnosed with Merkel cell cancer in late 2003, underwent
surgery, radiation therapy, and chemotherapy, but her cancer had reappeared
by
late 2004. After commencing treatment with huN901-DM1 through this study,
she
has been in complete remission for at least 15 weeks.
Stable
disease lasting 6 to 18 weeks was reported in an additional five patients.
Response information was available for twenty-one patients at the time of
the
poster presentation, inclusive of patients receiving the lowest dose levels
tested.
-more-
To
date,
five dose levels - 4, 8, 16, 24, and 36 mg/m2/day
-
have been assessed without establishing the maximum tolerated dose, and
evaluation of 48 mg/m2/day
is
underway. HuN901-DM1 has been generally well tolerated. Four individuals
had
serious adverse events that were considered to be at least possibly drug-related
(one patient each): fatigue, constipation, pancreatitis, and hypotension
plus
myocardial infarction. No clinically significant myelosuppression or serious
infusion reactions were reported, nor was thyroid or adrenal dysfunction
reported.
Robert
J.
Fram, MD, Vice President, Clinical Development, commented, “We are pleased with
the findings to date in this ongoing study. These data provide further support
that huN901-DM1 is generally well tolerated as well as evidence of anti-tumor
activity in patients with CD56-expressing solid tumors.”
HuN901-DM1
is wholly-owned by ImmunoGen. The compound is designed to target and kill
CD56-expressing cancer cells and is in clinical testing for the treatment
of
SCLC, other CD56-positive solid tumors, and multiple myeloma. HuN901-DM1
comprises the anti-CD56 antibody, huN901, and the potent cell-killing agent,
DM1. The huN901 antibody is used to target the compound specifically to
CD56-positive cancer cells and the DM1 serves to kill these cells.
The
data
reported at the AACR-NCI-EORTC conference today are from a clinical trial
established and managed by Vernalis plc, which formerly had certain marketing
rights to huN901-DM1.
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. Four TAP compounds are in clinical testing
-
huN901-DM1 and huC242-DM4, which are wholly owned by ImmunoGen, and MLN2704
and
AVE9633, which are in development by Millennium Pharmaceuticals, Inc. and
the
sanofi-aventis Group, respectively. Genentech, Centocor (a wholly-owned
subsidiary of Johnson & Johnson), Biogen Idec, the sanofi-aventis Group,
Millennium Pharmaceuticals, Inc., Boehringer Ingelheim, and Abgenix have
licensed the right to develop and/or test TAP compounds to specific targets;
ImmunoGen also has a broader collaboration with the sanofi-aventis
Group.
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, 2005 and other reports
filed with the Securities and Exchange Commission.
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