CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dec. 8, 2007--ImmunoGen, Inc.
(Nasdaq: IMGN), a biopharmaceutical company that develops targeted
anticancer therapeutics using its Tumor-Activated Prodrug (TAP)
technology, announced that encouraging clinical findings were reported
today at the American Society of Hematology (ASH) 49th Annual Meeting
and Exposition with IMGN901 (huN901-DM1) and AVE1642.
Highlights of the findings reported today include:
- 2 patients with multiple myeloma that had failed treatment
with a number of prior therapies had an objective response to
treatment with IMGN901 (abstract #1174). IMGN901 has been
found to be well tolerated in this patient population, and
dose escalation in the trial reported is ongoing.
- AVE1642 was successfully evaluated as monotherapy for multiple
myeloma in its first Phase I study and is now being tested in
combination with Velcade(R) (bortezomib) (abstract #1166).
"We are pleased with the results reported today," commented
Mitchel Sayare, Chairman and CEO. "Both of these compounds can have an
important role to play in the treatment of patients with multiple
myeloma as well as other cancers. We believe development of IMGN901
for multiple myeloma is the fastest pathway to approval for this
compound, and expect to announce our next steps in its clinical
development in early 2008. Sanofi-aventis has implemented an
aggressive Phase I program for AVE1642, and we look forward to
additional clinical findings being reported with the compound,
including data on its clinical activity when used in combination with
Velcade."
IMGN901 Clinical Findings Reported
IMGN901 is in development for the treatment of cancers that
express the CD56 antigen targeted by the compound. The findings
reported today are from a Phase I trial evaluating IMGN901 for the
treatment of CD56-expressing multiple myeloma that has failed multiple
prior therapies. The primary objective of this trial is to establish
the dose-limiting toxicities (DLT) and maximum tolerated dose (MTD) of
IMGN901 in this patient population when administered weekly for two
weeks in a three-week cycle; evidence of biological activity also is
identified.
In this dose-escalation trial, new cohorts of patients are given
increasing doses of IMGN901 until DLT is observed. To date, four dose
levels - 40, 60, 75, and 90 mg/m2/week - have been evaluated in
cohorts of three patients each. DLT has not been reported, and dose
escalation is ongoing - two patients are receiving IMGN901 at the next
dose level (112 mg/m2/week).
No evidence of biological activity was reported among the patients
who received the lowest dose evaluated (40 mg/m2/week). In contrast, 2
of the 9 patients who received either 60, 75, or 90 mg/m2/week had an
objective response to treatment.
- A patient treated with IMGN901 at 60 mg/m2/week had a minimal
objective response, characterized by a reduction in serum M
component by 39%, the disappearance of urine M component, and
no evidence of progressive disease in skeleton or bone marrow.
This patient previously had been treated with a number of
multiple myeloma therapies, including Thalomid(R)
(thalidomide) and Revlimid(R) (lenalidomide). She received
fifteen cycles of IMGN901 over 45 weeks.
- A patient treated with IMGN901 at 90 mg/m2/week was responding
to treatment until she needed to drop out of the study due to
a broken leg. She was experiencing a marked drop in serum M
component while she was in the study, and already had a
minimal objective response at the time she had to drop out.
This patient's multiple myeloma also had relapsed after
treatment with a number of prior therapies, including
Thalomid, Revlimid, and Velcade. She received a total of four
cycles of treatment.
"We are encouraged by the findings to date with IMGN901 in these
patients with relapsed/refractory multiple myeloma," commented Asher
Chanan-Khan, M.D., of the Roswell Park Cancer Institute. "The compound
has been well tolerated to date, with no clinically significant
myelosuppression or infusion reactions. Additionally, it has
demonstrated compelling evidence of biological activity in patients
whose multiple myeloma has relapsed after treatment with well accepted
prior therapies."
IMGN901, a TAP compound, is wholly owned by ImmunoGen. It consists
of ImmunoGen's highly potent cell-killing agent, DM1, attached to the
Company's CD56-binding antibody, huN901. The antibody serves to
deliver IMGN901 specifically to its target cancer cells. Once the
compound has bound to and entered the cancer cells, the DM1 is
released to kill the cells.
AVE1642 Clinical Findings Reported
AVE1642 is a "naked" (non-conjugated) antibody that binds to
IGF-1R. It is designed to block a pathway that is used by cancer cells
to survive chemotherapy treatments. AVE1642 was initially developed by
ImmunoGen and was licensed to sanofi-aventis as part of a broader
collaboration between the companies.
The findings reported today are from a Phase I study in which
AVE1642 is administered as monotherapy to patients with advanced
multiple myeloma. As the compound is designed to be used in
combination with chemotherapy, the purpose of this study was to
determine the "selected dose" - the AVE1642 dose to be used in further
evaluation of the compound. Three dose levels were evaluated, and the
highest dose - 12 mg/kg given every three weeks - was chosen as the
selected dose based on pharmacokinetic and pharmacodynamic parameters.
AVE1642 was well tolerated and DLT was not observed. Two diabetic
patients in the study had Grade 3 hyperglycemia, which was readily
reversible. While this study was not designed to assess the activity
of AVE1642, the investigators noted that a patient with Bence-Jones
multiple myeloma experienced a decrease in proteinuria and relief of
bone pain following treatment with AVE1642.
Once the selected dose was established for AVE1642, sanofi-aventis
initiated two additional Phase I trials with the compound.
- Sanofi-aventis began evaluation of AVE1642 for the treatment
of solid tumors. The compound is administered as monotherapy
in the Phase I trial currently underway.
- Sanofi-aventis also advanced the evaluation of the compound
for the treatment of hematological or "liquid" tumors by
starting a Phase I study that assesses AVE1642 when used in
combination with Velcade in patients with relapsed/refractory
multiple myeloma. In this trial, AVE1642 is administered at 12
mg/kg every three weeks and Velcade is administered at its
approved dosing schedule (1.3 mg/m2 given on Days 1, 4, 8, and
11 every three weeks). AVE1642 has been shown to have
synergistic activity when given in combination with Velcade in
preclinical studies.
"These data are highly promising and show the synergistic
combination of our clinical development expertise and ImmunoGen's
antibody expertise," stated Sylvain Durrleman, MD, Vice President,
Clinical Development, sanofi-aventis. "We are enthusiastic about the
anticancer potential offered by AVE1642."
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. Two TAP compounds wholly owned by ImmunoGen are in
clinical testing - IMGN901 and IMGN242 (huC242-DM4). Three TAP
compounds are in clinical testing through ImmunoGen's collaborations
with other companies - AVE9633 and SAR3419, in development by
sanofi-aventis, and T-DM1 (trastuzumab-DM1), in development by
Genentech. Additionally, the naked antibody compound, AVE1642, is in
development through the Company's collaboration with sanofi-aventis.
Multiple compounds are in research/preclinical development through
ImmunoGen's collaborations and internal programs.
This press release includes forward-looking statements based on
management's current expectations. The statements include, but are not
limited to, the statements that ImmunoGen believes both IMGN901 and
AVE1642 can have an important role to play in the treatment of
patients with multiple myeloma as well as other cancers; that the
development of IMGN901 for multiple myeloma is the fastest pathway to
approval for IMGN901; that ImmunoGen expects to announce the next
steps in the clinical development of IMGN901 in early 2008; and that
ImmunoGen expects additional clinical findings to be reported with
AVE1642, including data on the compound's clinical activity when used
in combination with Velcade. 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.
Various factors could cause ImmunoGen's actual results to differ
materially from those discussed or implied in the forward-looking
statements and you are cautioned not to place undue reliance on these
forward-looking statements, which are current only as of the date of
this release. Factors that could cause future results to differ
materially from such expectations include, but are not limited to the
difficulties inherent in the development of novel pharmaceuticals,
including uncertainties as to the timing, expense and results of
preclinical and clinical studies, and other factors more fully
described in ImmunoGen's Annual Report on Form 10-K for the fiscal
year ended June 30, 2007 and other reports filed with the Securities
and Exchange Commission.
Velcade(R) is a registered trademark of Millennium
Pharmaceuticals, Inc.
Thalomid(R) and Revlimid(R) are registered trademarks of Celgene
Corporation.
CONTACT:
Investors
ImmunoGen, Inc.
Carol Hausner, 617-995-2500
Executive Director, Investor Relations
and Corporate Communications
info@immunogen.com
Media:
For ImmunoGen, Inc.
KMorrisPR
Kathryn Morris, 845-635-9828
Kathryn@kmorrispr.com
