ImmunoGen Announces Investigational New Drug Application for IMGN632 for Hematological Malignancies is Active
October 16 2017 - 8:00AM
Business Wire
ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field
of antibody-drug conjugates (ADCs) for the treatment of cancer,
today announced that the U.S. Food and Drug Administration (FDA)
has completed the safety review of its investigational new drug
(IND) application for IMGN632 in patients with CD123-positive
hematological malignancies, including acute myeloid leukemia (AML)
and blastic plasmacytoid dendritic cell neoplasm (BPDCN). Filed in
mid-September, the IND is now in effect and ImmunoGen plans to open
a Phase 1 study to enrollment before the end of the year.
“IMGN632 is the second ADC from our pipeline to use one of
ImmunoGen’s indolino-benzodiazepine cancer-killing agents known as
IGNs,” said Richard Gregory, Ph.D., Executive Vice President and
Chief Scientific Officer of ImmunoGen. “Our IGN payloads were
designed to meet the dual challenges of achieving high potency
against target cells, while having a tolerability profile that can
enable continued patient treatment. Based on the encouraging
preclinical findings, IMGN632 represents a potentially promising
therapeutic approach for a range of hematological malignancies and
we are working to transition this compound rapidly into clinical
development before the end of the year.”
IMGN632 uses ImmunoGen’s novel DGN549 IGN payload, linker, and
antibody technology and in preclinical models has demonstrated an
impressive therapeutic window against CD123-positive malignancies.
Preclinical findings reported at the 58th American Society of
Hematology (ASH) Annual Meeting show that IMGN632, which alkylates
DNA, had 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 effective, yet tolerable ADC for AML
patients. Supporting preclinical data for IMGN632 showed compelling
activity in AML xenograft models.
About IMGN632IMGN632 is a humanized anti-CD123
antibody-drug conjugate that is a potential treatment for AML,
BPDCN, myelodysplastic syndrome, B-cell acute lymphocytic leukemia,
and other CD123-positive malignancies. IMGN632 uses a novel IGN
payload, linker and antibody technology and in AML xenograft models
has demonstrated a large therapeutic index.1
About IGNsIndolino-benzodiazepine cancer-killing agents,
or IGNs, are a new class of cancer-killing agent developed by
ImmunoGen for use in ADCs. These ultra-potent, DNA-acting IGNs
alkylate DNA without crosslinking, which preclinically has resulted
in potent anti-leukemia activity with relative sparing of normal
hematopoietic progenitor cells.2,3 IMGN779, a CD33-targeting ADC in
Phase 1 testing for AML, was the first IGN ADC to enter clinical
testing.
About Acute Myeloid Leukemia (AML)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.
It is estimated that, in the U.S. alone, 21,380 patients will be
diagnosed with AML this year and 10,590 patients will die from the
disease.4
About ImmunoGen, Inc.ImmunoGen is a clinical-stage
biotechnology company that develops targeted cancer therapeutics
using its proprietary ADC technology. The Company’s lead product
candidate, mirvetuximab soravtansine, is in a Phase 3 trial for
FRα-positive platinum-resistant ovarian cancer, and is in a
Phase 1b/2 trial in combination regimens for earlier-stage
disease. ImmunoGen has three additional clinical-stage product
candidates, two of which are being developed in collaboration with
Jazz Pharmaceuticals. ImmunoGen's ADC technology is also used in
Roche's marketed product, Kadcyla®, and in programs in development
by Amgen, Bayer, Biotest, CytomX, Debiopharm, 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.
1 S. Adams et al, Abstract 2832, Presented at
the American Society of Hematology, December 3-6,
2016.2 S. Adams et al, Abstract P526, Presented at the
22nd Congress of the European Hematology
Association, June 22-25, 2017.3 Y. Kotvun et al.
(2016) Blood 128:768.4American Cancer Society (2016),
About Acute Myeloid Leukemia.
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, including risks
related to preclinical and clinical studies, their timings and
results. A review of these risks can be found in ImmunoGen's
Transition Report on Form 10-KT for the six-month transition period
ended December 31, 2016 and other reports filed with the Securities
and Exchange Commission.
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For InvestorsImmunoGen, Inc.Sarah Kiely,
781-895-0600sarah.kiely@immunogen.comorFor MediaImmunoGen,
Inc.Courtney O'Konek,
781-895-0600courtney.okonek@immunogen.comorFTI Consulting,
Inc.Robert Stanislaro,
212-850-5657robert.stanislaro@fticonsulting.com
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