Preclinical Data on IMGN632, a Novel CD123-Targeting ADC, Presented at ASH Annual Meeting
December 05 2016 - 2:45PM
Business Wire
Data Demonstrate Activity in Acute Myeloid
Leukemia Models While Sparing Normal Bone Marrow
ImmunoGen, Inc. (Nasdaq: IMGN), a
leader in the expanding field of antibody-drug conjugates (ADCs)
for the treatment of cancer, announced that preclinical data on
IMGN632, a novel CD123-targeting ADC, were presented today at the
58th American Society of Hematology (ASH) Annual Meeting in San
Diego, CA.
CD123 is an attractive target due to its elevated expression in
acute myeloid leukemia (AML). IMGN632 uses ImmunoGen’s new family
of indolino-benzodiazepine cancer-killing agents, called IGNs.
ImmunoGen designed IGNs to be highly potent and to alkylate DNA
without crosslinking it. Specifically, IMGN632 uses the Company’s
DGN549 payload and incorporates novel linker and conjugation
technology.
“We developed our DNA-alkylating IGN payloads to meet the dual
challenges of achieving high potency against target cells, while
having a tolerability profile that enables continued patient
treatment,” said Richard Gregory, Ph.D., Executive Vice President
and Chief Scientific Officer of ImmunoGen. “These preclinical data
demonstrate that IMGN632 has the potential for broad and potent
activity in patients with AML and an improved tolerability
profile.”
The data presented at ASH (oral abstract #768) compared IMGN632,
an ADC with an alkylating IGN, to a version of IMGN632 with a
crosslinking payload. In vitro cytotoxic activity was compared in
multiple AML cell lines. Both ADCs were found to be highly active
against AML cells, including those with poor prognostic markers
(FLT3-ITD, P53, MDR1), and were approximately 100-fold more active
on AML patient samples than gemtuzumab ozogamicin.
Both ADCs exhibited similar efficacy in human AML xenograft
models; however, the effects of the ADCs in toxicity studies were
very different. While IMGN632, the alkylating ADC, was well
tolerated at the dose tested, the crosslinking ADC showed
persistent delayed toxicity (weight loss) at less than half the
dose.
In addition, on normal bone marrow cells, IMGN632 was
approximately 50-fold less toxic than the crosslinking ADC, while
retaining high potency against AML cells.
These results show that IMGN632 has potent selective activity
against AML cells with lower cytotoxicity to normal myeloid
progenitor cells than an ADC designed to crosslink DNA activity.
These data suggest IMGN632 has the potential to be a highly potent
yet tolerable ADC for AML patients.
Supporting preclinical data were also presented at ASH in which
IMGN632 showed compelling activity in AML xenograft models
(abstract #2832).
The Company plans to submit an IND application and initiate
clinical testing of IMGN632 in 2017.
Preclinical data were also presented at ASH on IMGN779, a potent
CD33-targeting ADC using an IGN payload, (abstract #1645) from a
combination study of IMGN779 with a PARP inhibitor (olaparib). The
data demonstrated enhanced activity in several AML models including
patient derived tumor cells and a disseminated AML xenograft model.
IMGN779 is currently being evaluated in a Phase 1 study as a
monotherapy in AML.
About Acute Myeloid LeukemiaAcute myeloid leukemia (AML)
is a cancer of the bone marrow cells that produce white blood
cells. It causes the marrow to increasingly generate abnormal
immature white blood cells (blasts) that do not mature into
effective infection-fighting cells. The blasts quickly fill the
bone marrow, impacting the production of normal platelets and red
blood cells. The resulting deficiencies in normal blood cells leave
the patient vulnerable to infections, bleeding problems and
anemia.
In 2016, it is estimated that nearly 20,000 new cases of AML
will be diagnosed in the U.S. and more than 10,000 people will die
from the disease.1
About ImmunoGenImmunoGen is a clinical-stage
biotechnology company that develops targeted cancer therapeutics
using its proprietary ADC technology. ImmunoGen’s lead product
candidate, mirvetuximab soravtansine, is being advanced to a Phase
3 trial for FRα-positive platinum-resistant ovarian cancer, and is
in Phase 1b/2 testing in combination regimens for
earlier-stage disease. ImmunoGen’s ADC technology is used in
Roche's marketed product, Kadcyla®, in three other clinical-stage
ImmunoGen product candidates, and in programs in development by
partners Amgen, Bayer, Biotest, CytomX, Lilly, Novartis, Sanofi and
Takeda. More information about the Company can be found at
www.immunogen.com.
Kadcyla® is a registered trademark of Genentech, a member of the
Roche Group.
1American Cancer Society (2016), Leukemia – Acute Myeloid
(Myelogenous) Detailed Guide.
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 IMGN632 and IMGN779, 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, 2016
and other reports filed with the Securities and Exchange
Commission.
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version on businesswire.com: http://www.businesswire.com/news/home/20161205005872/en/
Investor Contact:ImmunoGen, Inc.Sarah Kiely,
781-895-0600sarah.kiely@immunogen.comorMedia
Contacts:ImmunoGen, Inc.Amy Reilly,
781-895-0138amy.reilly@immunogen.comorFTI Consulting, Inc.Robert
Stanislaro, 212-850-5657robert.stanislaro@fticonsulting.com
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