ImmunoGen Announces Initiation of Clinical Testing of First-in-Class IMGN779 for Acute Myeloid Leukemia
April 18 2016 - 6:30AM
Business Wire
- Novel CD33-targeting product candidate
is the first antibody-drug conjugate (ADC) to employ an IGN, a new
type of cancer-killing agent.
- Phase 1 study in acute myeloid leukemia
(AML) is designed to efficiently inform the IMGN779 development
pathway.
ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that
develops targeted anticancer therapeutics using its extensive ADC
technology portfolio, today announced the start of clinical testing
of the Company’s IMGN779 product candidate for the treatment of
AML, a CD33-positive cancer.
IMGN779 contains a CD33-targeting antibody – enabling it
to bind to AML cells – with a powerful cancer-killing agent
attached to kill them. IMGN779 is the first ADC to utilize one of
ImmunoGen’s new family of indolino-benzodiazepine cancer-killing
agents, which the Company calls IGNs. DNA-alkylating IGNs have been
designed to be ultra-potent, yet provide the tolerability necessary
for ongoing retreatment.
“There is substantial need for new therapies for AML and
considerable appeal to an ADC approach,” said Ravi Chari, Ph.D., VP
of Chemistry and Biochemistry. “A key challenge has been achieving
the potency needed for clinical benefit with the tolerability
required for continued patient retreatment. We developed our
DNA-alkylating IGNs to meet these dual needs and believe this
innovative new class can further extend the types of cancers that
can be effectively treated with ADC therapeutics.”
The IMGN779 Phase 1 trial in CD33-positive AML will assess two
alternative dosing schedules – weekly and biweekly administration –
concurrently in its dose-finding stage. The selected dose and
schedule will then be used in the two planned expansion cohorts:
one assessing IMGN779 in patients with AML in first relapse and one
assessing it in patients with relapsed/refractory AML.
“IMGN779 has the potential to make an important difference for
patients with AML,” said Anna Berkenblit, MD, VP and Chief Medical
Officer. “This Phase 1 trial has been designed to efficiently
inform the development pathway for IMGN779 by assessing alternative
dosing schedules concurrently and then evaluating the selected
schedule in specific under-served patient populations.”
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
leaves the patient vulnerable to infections, bleeding problems and
anemia.
It is estimated that, in the US alone, 20,000 patients will be
diagnosed with AML this year and 10,000 patients will die from the
disease.1 CD33 is expressed in virtually all cases of AML.
About IMGN779
IMGN779 comprises a CD33-targeting antibody with a potent
DNA-alkylating agent, the IGN DGN462, attached. The antibody serves
to target the ADC to the CD33-positive AML cells which DGN462 can
then kill. IMGN779 is wholly owned by ImmunoGen.
About IGNs
IGNs are a new class of cancer-killing agent developed by
ImmunoGen for use in ADCs. Ultra-potent, these DNA-alkylating
indolino-benzodiazepines are expected to extend the types of
cancers able to be effectively treated with ADC therapies beyond
those addressable with ImmunoGen’s well-established tubulin-acting
agents. Such cancers can include ones insensitive to tubulin-acting
agents and/or with reduced antigen expression.
About ImmunoGen, Inc.
ImmunoGen is a clinical-stage biotechnology company that
develops targeted anticancer therapeutics using its proprietary ADC
technology. The Company has four wholly owned clinical-stage ADCs.
The lead, mirvetuximab soravtansine, is in Phase 2 testing for the
treatment of folate receptor α-positive ovarian cancer. ImmunoGen's
ADC technology is used in Roche's marketed product, Kadcyla®, and
in agents 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.
1American Cancer Society (2016), Leukemia – Acute Myeloid
(Myelogenous) Detailed Guide.
ImmunoGen Forward-Looking Statement
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 agents, including IMGN779 and IGNs, including
risks related to clinical studies and regulatory processes, 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, 2015 and other reports filed with the Securities and
Exchange Commission.
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version on businesswire.com: http://www.businesswire.com/news/home/20160418005209/en/
For Investors:ImmunoGen, Inc.Carol Hausner,
781-895-0600info@immunogen.comorFor Media:Michael Lampe,
484-575-5040michael@scientpr.com
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