ImmunoGen Announces Clinical Collaboration with Gilead to Evaluate Pivekimab Sunirine in Combination with Magrolimab in Relapsed/Refractory Acute Myeloid Leukemia
December 09 2022 - 6:30AM
Business Wire
Collaboration to Explore Potential of Complementary Mechanisms
of Action for Novel Doublet
ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field
of antibody-drug conjugates (ADCs) for the treatment of cancer,
today announced a clinical collaboration with Gilead Sciences, Inc.
(Nasdaq: GILD) to evaluate the safety and anti-leukemia activity of
pivekimab sunirine (pivekimab) in combination with magrolimab, a
potential, first-in-class, investigational CD47 inhibitor, in
patients with relapsed or refractory (R/R) CD123-positive acute
myeloid leukemia (AML).
"AML is the most common form of acute leukemia among adults and
accounts for the largest number of deaths from leukemia in both the
United States and Europe," said Anna Berkenblit, MD, Senior Vice
President and Chief Medical Officer of ImmunoGen. "Given the
potentially complementary mechanisms of action, the limited overlap
in safety profiles, and the encouraging data seen with each agent
in combinations to date, we are excited to explore this novel
doublet in patients with relapsed/refractory AML, where few
effective treatment options exist."
Expected to initiate in 2023, the collaboration will be a new
cohort in ImmunoGen's 802 study and will evaluate pivekimab in
combination with magrolimab in up to 42 patients with R/R
CD123-positive AML. The primary endpoint for this cohort is
complete response (CR) rate. ImmunoGen's 802 study is an
open-label, multicenter, Phase 1b/2 trial to determine the safety
and tolerability of pivekimab and assess the anti-leukemia activity
of the agent when administered in combination with Vidaza®
(azacitidine) and/or Venclexta® (venetoclax) in patients with
relapsed and frontline CD123-positive AML.
ABOUT PIVEKIMAB SUNIRINE
Pivekimab sunirine is a CD123-targeting ADC in clinical
development for hematological malignancies, including blastic
plasmacytoid dendritic cell neoplasm (BPDCN), acute myeloid
leukemia (AML), and other CD123+ hematologic malignancies.
Pivekimab is currently being evaluated as monotherapy for patients
with BPDCN and in combination with Vidaza® (azacitidine) and
Venclexta® (venetoclax) for patients with untreated and
relapsed/refractory AML. Pivekimab uses one of ImmunoGen's novel
indolinobenzodiazepine (IGN) payloads, which alkylate DNA and cause
single strand breaks without crosslinking. IGNs are designed to
have high potency against tumor cells, while demonstrating less
toxicity to normal marrow progenitors than other DNA-targeting
payloads. The European Medicines Agency (EMA) granted orphan drug
designation to pivekimab for the treatment of BPDCN in June 2020.
Pivekimab also holds this designation in the U.S. In October 2020,
the FDA granted pivekimab Breakthrough Therapy designation in
relapsed/refractory BPDCN.
ABOUT MAGROLIMAB
Magrolimab is a potential, first-in-class, investigational
treatment designed to inhibit the CD47 protein. CD47 binds to
receptors on macrophages to transmit a "don't eat me" signal used
by cancer cells to escape natural cell death, called phagocytosis.
Targeting the CD47 protein, magrolimab is intended to restore
phagocytosis. Magrolimab is being studied in several hematologic
cancers as well as solid tumor malignancies. Granted Fast Track
Designation by the FDA for the treatment of myelodysplastic
syndrome (MDS), AML, diffuse large B-cell lymphoma (DLBCL) and
follicular lymphoma, magrolimab has also been granted Orphan Drug
Designation by the FDA for MDS and AML and by the European
Medicines Agency for AML. More information about clinical trials
with magrolimab is available at www.clinicaltrials.gov.
Magrolimab is an investigational product and is not approved by
any regulatory authority for any use; its safety and efficacy have
not been established.
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, more than 20,000
people will be diagnosed with AML this year and more than 11,000
will die from the disease.
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. These
statements include, but are not limited to, ImmunoGen's
expectations related to: the potential benefits and results that
may be achieved through ImmunoGen's clinical collaboration with
Gilead; and the occurrence, timing, and outcome of potential
preclinical, clinical, and regulatory events related to, and the
potential benefits of, ImmunoGen's product candidates. 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 preclinical and clinical
development processes; the difficulties inherent in the development
of novel pharmaceuticals, including uncertainties as to the timing,
expense, and results of preclinical studies, clinical trials, and
regulatory processes; ImmunoGen's ability to financially support
its product programs; the timing and outcome of ImmunoGen's
anticipated interactions with regulatory authorities; risks and
uncertainties associated with the scale and duration of the
COVID-19 pandemic and the resulting impact on ImmunoGen's industry
and business; and other factors as set forth in ImmunoGen's Annual
Report on Form 10-K filed with the Securities and Exchange
Commission on February 28, 2022, Quarterly Reports on Form 10-Q
filed with the Securities and Exchange Commission on May 6, 2022,
August 1, 2022 and November 4, 2022, and other reports filed with
the Securities and Exchange Commission. The forward-looking
statements in this press release speak only as of the date of this
press release. We undertake no obligation to update any
forward-looking statement, whether as a result of new information,
future developments, or otherwise, except as may be required by
applicable law.
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version on businesswire.com: https://www.businesswire.com/news/home/20221209005072/en/
INVESTOR RELATIONS ImmunoGen Anabel Chan 781-895-0600
anabel.chan@immunogen.com
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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