- Abstracts made public today provide
insight on biological effects seen at low doses with IMGN529 and on
observed activity threshold for IMGN853.
- Abstracts also add to growing body of
data on the significance of partner compounds, including the
findings reported on the activity and tolerability of SAR3419 in
the Phase II STARLYTE trial.
ImmunoGen, Inc. (NASDAQ: IMGN), a biotechnology company that
develops novel anticancer therapeutics using its antibody-drug
conjugate (ADC) 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 emtansine).
“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 compounds.”
IMGN529
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 0.4 mg/kg.
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 study 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.
IMGN853
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
(FRα)-targeting antibody drug conjugate in patients with epithelial
ovarian cancer (EOC) and other FRα-positive solid tumors.”
IMGN853 comprises a FRα-targeting antibody with the potent DM4
cytotoxic agent attached. This ADC is a potential treatment for
FRα-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-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
multiple myeloma.”
- Poster presentation: Friday, May 30,
1:00-4:00 CT, S 405, poster board #12
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 Exchange
Commission.
For Investors:ImmunoGen, Inc.Carol Hausner,
781-895-0600info@immunogen.comorFor Media:Pure Communications,
Inc.Dan Budwick, 973-271-6085
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