ImmunoGen Announces FDA Breakthrough Therapy Designation for IMGN632 in Relapsed or Refractory Blastic Plasmacytoid Dendritic...
October 05 2020 - 6:30AM
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 granted Breakthrough Therapy designation for IMGN632 for the
treatment of patients with relapsed or refractory blastic
plasmacytoid dendritic cell neoplasm (BPDCN).
“We are pleased FDA has granted Breakthrough Therapy designation
for IMGN632, our novel CD123-targeted ADC, as it underscores the
urgent need for effective and well-tolerated treatments for
patients with this rare and aggressive cancer,” said Mark Enyedy,
ImmunoGen’s President and Chief Executive Officer. “We look forward
to continuing to work with FDA to further define the development
path for IMGN632 in BPDCN, in addition to pursuing our ongoing
evaluation of IMGN632 in AML and other hematological
malignancies.”
According to FDA guidelines, Breakthrough Therapy designation is
designed to expedite the development and review of drugs that are
intended to treat a serious condition and have generated
preliminary clinical evidence that the drug may demonstrate
substantial improvement over available therapy. Breakthrough
Therapy designation was granted for IMGN632 based on the findings
from the BPDCN cohort of the first-in-human study of IMGN632, for
which initial data were presented in an oral session at the
American Society of Hematology (ASH) Annual Meeting in 2019.
Updated data from the IMGN632 monotherapy BPDCN dose expansion
cohort will be presented at ASH this December.
ABOUT IMGN632 IMGN632 is a CD123-targeting ADC in
clinical development for hematological malignancies, including
blastic plasmacytoid dendritic cell neoplasm (BPDCN), acute myeloid
leukemia (AML), and acute lymphocytic leukemia (ALL). IMGN632 is
currently being evaluated in multiple cohorts, including
monotherapy for patients with BPDCN and minimal residual disease
positive (MRD+) AML following frontline induction therapy and in
combinations with Vidaza® (azacitidine) and Venclexta® (venetoclax)
for patients with relapsed/refractory AML. IMGN632 uses one of
ImmunoGen's novel indolino-benzodiazepine (IGN) payloads, which
alkylate DNA without crosslinking. IGNs have been designed to have
high potency against AML blasts, while demonstrating less toxicity
to normal marrow progenitors than other DNA-targeting payloads.
ABOUT BLASTIC PLASMACYTOID DENDRITIC CELL NEOPLASM BPDCN
is a rare form of blood cancer that has features of both leukemia
and lymphoma, with characteristic skin lesions, lymph node
involvement, and frequent spread to the bone marrow. This
aggressive cancer requires intense treatment often followed by stem
cell transplant. Despite the recent approval of a CD123-targeting
therapy, the unmet need remains high for patients, particularly in
the relapsed/refractory setting.
ABOUT IMMUNOGEN ImmunoGen is developing the next
generation of antibody-drug conjugates (ADCs) to improve outcomes
for cancer patients. By generating targeted therapies with enhanced
anti-tumor activity and favorable tolerability profiles, we aim to
disrupt the progression of cancer and offer our patients more good
days. We call this our commitment to “target a better now.”
Learn more about who we are, what we do, and how we do it at
www.immunogen.com.
Vidaza® and Venclexta® are registered trademarks of their
respective owners.
FORWARD-LOOKING STATEMENTS This press release includes
forward-looking statements based on management's current
expectations. These statements include, but are not limited to,
ImmunoGen’s expectations related to: the occurrence, timing, and
outcome of potential pre-clinical, clinical, and regulatory events
related to ImmunoGen’s product candidates; and the presentation of
pre-clinical and clinical data on ImmunoGen’s product candidates.
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 timing and
outcome of ImmunoGen’s pre-clinical and clinical development
processes; the difficulties inherent in the development of novel
pharmaceuticals, including uncertainties as to the timing, expense,
and results of pre-clinical studies, clinical trials, and
regulatory processes; ImmunoGen’s ability to financially support
its product programs; risks and uncertainties associated with the
scale and duration of the COVID-19 pandemic and resulting impact on
ImmunoGen’s industry and business; and other factors more fully
described in ImmunoGen’s Annual Report on Form 10-K for the year
ended December 31, 2019 and other reports filed with the Securities
and Exchange Commission.
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INVESTOR RELATIONS AND MEDIA ImmunoGen Courtney O’Konek
781-895-0600 courtney.okonek@immunogen.com OR FTI Consulting
Robert Stanislaro 212-850-5657
robert.stanislaro@fticonsulting.com
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