|[May 14, 2014]
ImmunoGen, Inc. Announces Clinical Data Presentations at Upcoming 50th Annual Meeting of ASCO
WALTHAM, Mass. --(Business Wire)--
Inc. (NASDAQ: IMGN), a biotechnology company that develops novel
anticancer therapeutics using its antibody-drug conjugate (ADC (News - Alert))
technology, today provided information on the data presentations on
Company and partner compounds to be made at the 2014 American Society of
Clinical Oncology (ASCO) annual meeting, which will be held May 30-June
3 in Chicago, IL. New clinical data are being presented on ImmunoGen
wholly owned compounds, IMGN529 and IMGN853, as well as on partner
compounds SAR3419, SAR650984 and Kadcyla® (ado-trastuzumab
"The presentations on our wholly owned product candidates reflect
the unique and promising profile of these compounds as well as our
strengthened drug development capabilities," commented Daniel Junius,
President and CEO. "At the same time, the presentations on partner
compounds add to the growing body of data on the importance of these
Poster presentation: Friday, May 30,
1:00-4:00pm CT; Lymphoma and Plasma Cell Disorders Poster Highlights
Session, S405, poster board #6. Abstract #8526:
"Preliminary findings from a phase I, multicenter, open-label study of
the anti-CD37 antibody-drug conjugate (ADC), IMGN529, in adult patients
with relapsed or refractory non-Hodgkin lymphoma (NHL)."
IMGN529 contains a CD37-targeting antibody that demonstrates pronounced
activity against CD37-positive cancer cells in preclinical models with
the potent cytotoxic agent, DM1, attached. It is currently in
dose-finding Phase I clinical testing for the treatment of NHL; its
maximum-tolerated dose (MTD) is not yet established.
The data made public today in the abstract include that patient dosing
with IMGN529 began at 0.1 mg/kg, administered once every three weeks,
with new cohorts of patients receiving progressively higher dose levels
up to 0.8 mg/kg. As the Company disclosed late last year, biological
changes were unexpectedly observed at these low doses.
As reported in the abstract, these included the occurrence of Grade 3 or
4 asymptomatic neutropenia or febrile neutropenia in 5 and 2,
respectively, of the 18 patients enrolled. The biological changes also
included a post-dosing reduction in lymphocytes, consistent with
IMGN529's anticancer mechanism of action. Additionally, 2 patients had
partial remissions (PRs): a patient with follicular lymphoma treated at
0.2 mg/kg and a patient with diffuse large B-cell lymphoma treated at
Many patients have been treated with ADCs containing DM1 to targets
other than CD37 without evidence of activity at such low dose levels and
without neutropenia. In researching the neutropenia reported, it was
found that, in the majority of the patients, it occurred shortly after
the patient received the first dose of IMGN529 and was transient in
nature, suggesting it was a manifestation of cytokine release. The stuy
protocol was thus amended to include peri-infusional steroids as a
prophylactic method. The abstract made public today includes favorable
initial findings after this protocol change.
Poster presentation: Saturday, May 31,
8:00-11:45am CT; Gynecologic Cancer Poster Session, S Hall A2, poster
board #353. Abstract #5571: "Relationship
of pharmacokinetics (PK), toxicity, and initial evidence of clinical
activity with IMGN853, a folate receptor alpha (FRa)-targeting antibody
drug conjugate in patients with epithelial ovarian cancer (EOC) and
other FRa-positive solid tumors."
IMGN853 comprises a FRa-targeting antibody with the potent DM4 cytotoxic
agent attached. This ADC is a potential treatment for FRa-positive solid
tumors - which include many ovarian and endometrial cancers - and is
currently in dose-finding Phase I clinical testing. As reported
previously, dosing in the trial was changed from use of patient total
body weight (TBW) to adjusted ideal body weight (AIBW) based on findings
from PK modeling that AIBW should minimize inter-patient variability in
IMGN853 blood levels.
The data in the abstract made public today are from 30 patients treated
with IMGN853 before the change from TBW to AIBW. As noted, 24 of these
patients were treated at doses of 3.3 mg/kg or more, administered once
every three weeks. This compares with 13 patients in the findings
reported at ASCO in 2013 because of the treatment of additional patients
at the 3.3 and/or 5.0 mg/kg dose levels.
As disclosed in the abstract, preliminary evidence of clinical activity
was observed in 10 of these 24 patients, with clinical activity defined
as CA (News - Alert)-125 response by CGIC criteria, stable disease lasting 18 or more
weeks, and/or an objective response. It was observed that a
quantifiable, minimum level of total exposure to IMGN853 was associated
with evidence of anticancer activity. Clinical activity was seen in 5 of
the 6 patients with ovarian cancer (serous or transitional EOC) and in 2
of the 4 patients with endometrial cancer whose IMGN853 exposure
exceeded this level.
It was previously reported that the occurrence of its dose-limiting
toxicity (DLT) was associated with IMGN853 blood levels exceeding
definable thresholds.1 That IMGN853 activity is associated
with total exposure while its DLT is associated with peak exposure
supports achievement of an appropriate therapeutic window and that
dosing IMGN853 in smaller amounts more frequently may be preferable to
once every three week dosing. Assessment of a modified weekly schedule
was added to the ongoing Phase I trial earlier this year.
Presentations on Partner Compounds
In addition to multiple presentations on Kadcyla, data will be presented
on the CD19-targeting ADC SAR3419 and the CD38-targeting antibody
SAR650984, which are in development by Sanofi through a collaboration
with ImmunoGen. Among the data made public today are findings from the
STARLYTE Phase II trial showing SAR3419 therapy achieved a
43.9% objective response rate (ORR) when used as a single agent to treat
relapsed/refractory diffuse large B-cell lymphoma; an objective of the
study was to determine if it could achieve an ORR of at least 20%. Only
grade 1-2 eye disorders were reported, including one patient with
unrelated grade 2 keratitis.
Abstract #8532 "A phase I trial of
SAR650984, a CD38 monoclonal antibody, in relapsed or refractory
Poster presentation: Friday, May 30, 1:00-4:00 CT, S 405, poster board
Abstract #8506 "STARLYTE phase II study of
coltuximab ravtansine (CoR, SAR3419) single agent: Clinical activity and
safety in patients (pts) with relapsed/refractory (R/R) diffuse large
B-cell lymphoma (DLBCL; NCT01472887)."
Oral abstract: Sunday, June 1, 10:12am-10:24am CT, E Hall D2
Abstract #8512 "A phase Ib dose escalation
trial of SAR650984 (Anti-CD-38 mAb) in combination with lenalidomide and
dexamethasone in relapsed/refractory multiple myeloma."
Oral abstract: Monday, June 2, 8:48-9am CT, E354a
Additional information - including full abstracts - can be found at www.asco.org.
About ImmunoGen, Inc.
ImmunoGen, Inc. develops targeted anticancer therapeutics. The Company's
ADC technology uses tumor-targeting antibodies to deliver an ImmunoGen
cell-killing agent specifically to cancer cells; the Company has also
developed antibodies with anticancer activity of their own. The first
product with ImmunoGen's ADC technology is Roche's Kadcyla®.
ImmunoGen has three wholly owned product candidates in clinical testing
with additional compounds in clinical testing through the Company's
partnerships with Amgen, Bayer HealthCare, Biotest and Sanofi. More
information about ImmunoGen can be found at www.immunogen.com.
1Ponte et al., AACR 2014, abstract #4641.
Kadcyla® is a registered trademark of Genentech, a member of
the Roche 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 development of novel anticancer products,
including IMGN529 and IMGN853, including risks related to preclinical
and clinical studies, their timings and results. A review of these risks
can be found in ImmunoGen's Annual Report on Form 10-K for the fiscal
year ended June 30, 2013 and other reports filed with the Securities and
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