ImmunoGen, Inc. Form 8-K 11-14-05
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 14, 2005
ImmunoGen,
Inc.
(Exact
name of registrant as specified in its charter)
|
Massachusetts
|
0-17999
|
04-2726691
|
|
|
(State
or other jurisdiction of incorporation)
|
(Commission
File Number)
|
(IRS
Employer Identification No.)
|
|
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 14, 2005, ImmunoGen, Inc. (Nasdaq: IMGN) issued a press release
to
announce that ten poster presentations featuring clinical or preclinical
findings with the Company’s Tumor-Activated Prodrug (TAP) technology are to be
made at the AACR-NCI-EORTC International Conference on Molecular Targets
and
Cancer Therapeutics taking place this week in Philadelphia, PA. Four of these
posters will be presented by ImmunoGen researchers and six will be presented
by
researchers at companies that have licensed certain rights to use ImmunoGen’s
TAP technology.
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
Exhibit
No.
|
|
Exhibit
|
|
|
|
99.1
|
|
Press
Release of ImmunoGen, Inc. dated November 14,
2005
|
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.
|
ImmunoGen,
Inc.
|
|
(Registrant)
|
|
|
Date:
November 14, 2005
|
/s/
Karleen M. Oberton
|
|
|
|
Karleen
M. Oberton
|
|
Senior
Corporate Controller
|
|
(Principal
Accounting Officer)
|
Exhibit 99.1
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
Tony
Loke
Rx
Communications Group, LLC
Tel:
(917) 322-2164
tloke@rxir.com
|
For
Immediate Release
ImmunoGen,
Inc. Announces Clinical and Preclinical Findings with TAP Compounds to
be
Presented at the AACR-NCI-EORTC
International
Conference on Molecular Targets and Cancer Therapeutics
CAMBRIDGE,
MA November 14, 2005
-
ImmunoGen, Inc. (Nasdaq: IMGN) today announced that ten poster presentations
featuring clinical or preclinical findings with the Company’s Tumor-Activated
Prodrug (TAP) technology are to be made at the AACR-NCI-EORTC International
Conference on Molecular Targets and Cancer Therapeutics taking place
this week
in Philadelphia, PA. In addition to the four posters described below
that will
be presented by ImmunoGen researchers, another six will be presented
by
researchers at companies that have licensed certain rights to use ImmunoGen’s
TAP technology.
Phase
I Trial of BB-10901 (huN901-DM1) Given Daily by IV Infusion for Three
Consecutive Days Every Three Weeks in Patients with SCLC and other CD56-Positive
Solid Tumors. (Abstract #B97)
This
poster presentation will feature clinical findings with ImmunoGen’s huN901-DM1
product candidate in this ongoing Phase I trial. Study patients have
relapsed or
refractory small-cell lung cancer (SCLC) or other CD56-expressing solid
tumors.
As noted in the poster abstract (www.aacr.org),
dosage
has been escalated from 4 mg/m2/day
to
48 mg/m2/day,
given daily for three consecutive days in a 21-day cycle. The maximum
tolerated
dose for the compound has not yet been established.
Evidence
of clinical activity was reported and includes a complete remission (CR)
lasting
at least 15 weeks in a patient with relapsed metastatic CD56-expressing
Merkel cell carcinoma. Stable disease also has been reported in a number
of
patients.
This
poster will be presented on Wednesday, November 16, 2005, starting at
12:30 pm.
Additional details will be provided at that time.
ImmunoGen
Announces Posters at AACR-NCI-EORTC Conference
Page
2 of
3
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. The data
being
reported at the AACR-NCI-EORTC conference this week are from a clinical
trial
established and managed by Vernalis plc, which formerly had certain marketing
rights to huN901-DM1.
Additive
and Synergistic Effects of Combination Treatment with huN901-DM1 (BB-10901)
and
Chemotherapeutic Agents in Small Cell Lung Cancer Xenograft Tumor Models.
(Abstract #A58)
This
poster presentation will report preclinical findings on the activity
of
huN901-DM1 against human SCLC when used in combination with currently
available
treatments for SCLC. The treatments tested were cisplatin plus VP16,
topotecan,
and two taxanes (paclitaxel and docetaxel). As noted in the abstract,
it was
found that administration of huN901-DM1 in combination with any of these
treatments markedly enhanced the anticancer activity achieved - without
significant additional toxicity - compared with the effect of the available
treatment alone.
Pharmacokinetics
and Biodistribution in Mice of huC242-DM4, an Antibody-Maytansinoid Conjugate
that Targets CanAg-Positive Tumors. (Abstract #A69)
This
poster presentation will feature findings with ImmunoGen’s huC242-DM4 product
candidate in pharmacokinetic and biodistribution studies conducted in
mice. The
findings demonstrate that the antibody-drug linkage of huC242-DM4 is
stable
while the compound is circulating in the bloodstream. Additionally, it
was found
that huC242-DM4 successfully accumulates at the tumor site and that drug
levels
in the tumor remain higher than levels in the blood for an extended period
of
time.
HuC242-DM4
is in Phase I clinical testing for the treatment of cancers that express
CanAg,
which include colorectal, pancreatic, and other gastrointestinal cancers
as well
as many non-small cell lung cancers. HuC242-DM4 is wholly-owned by
ImmunoGen.
Mechanisms
of Anti-Cancer Activities of Antibody-Drug Conjugates: Targeted
Killing and
Target Cell-Activated Killing of Proximal Cells. (Abstract
#A71)
This
poster will present results from studies examining the impact of alterations
in
the design of a TAP compound on its ability to kill not only cancer cells
expressing its target antigen, but also neighboring antigen-negative
cancer
cells. This feature is felt to be particularly desirable in TAP compounds
created for the treatment of cancers that have irregular expression of
the
target antigen.
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
ImmunoGen
Announces Posters at AACR-NCI-EORTC Conference
Page
3
of
3
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.
#
#
#