Data demonstrate favorable safety profile with
repeat dosing and no dose-limiting toxicities
Dose-dependent biological and anti-leukemia
activity observed
ImmunoGen, Inc. (Nasdaq:IMGN), a leader in the expanding field
of antibody-drug conjugates (ADCs) for the treatment of cancer,
presented data from the ongoing Phase 1 study evaluating single
agent IMGN779 in patients with relapsed or refractory adult acute
myeloid leukemia (AML) whose tumors express CD33. The
first-in-human data demonstrate the safety and tolerability of
IMGN779 across seven dose levels, with no dose limiting toxicities
(DLTs), as well as evidence of dose-dependent biological and
anti-leukemia activity. These results were presented in a poster
presentation on Saturday, June 24, 2017, at the 22nd Congress of
the European Hematology Association (EHA) in Madrid, Spain.
IMGN779 combines a high-affinity, humanized anti-CD33 antibody
with one of ImmunoGen’s novel indolino-benzodiazepine payloads,
called IGNs, which alkylate DNA without crosslinking, resulting in
potent anti-leukemia activity with relative sparing of normal
hematopoietic progenitor cells.
Safety, pharmacokinetic (PK), and pharmacodynamic (PD) data, as
well as initial anti-leukemia activity for IMGN779 through dose
level seven were presented at EHA. Key findings included:
- No DLTs have been observed through dose
level seven, with reported adverse events consistent with the
underlying disease.
- No increase in the nature, frequency,
or severity of any treatment-emergent adverse event has been
reported with escalating doses and no evidence of cumulative
toxicity has been observed with repeated dosing.
- Favorable PK/PD reveal prolonged
exposure and CD33 saturation at dose levels six and seven.
- Initial anti-leukemia activity was
observed at dose levels six and seven in patients who failed
intensive frontline therapy.
The Phase 1 trial is designed to establish the maximum tolerated
dose and determine the recommended Phase 2 dose for IMGN779
administered as monotherapy. The trial is also intended to evaluate
safety and tolerability and characterize PK, PD, and preliminary
anti-leukemia activity in relapsed or refractory AML. Dose
escalation continues.
“We have designed our DNA-alkylating IGNs to be ultra-potent
while providing the tolerability necessary for ongoing
retreatment,” said Richard Gregory, Ph.D., executive vice president
and chief scientific officer of ImmunoGen. “We believe that by
combining IGNs with our ADC technology, we may be able to treat a
number of additional cancers that don’t respond to existing ADC
therapies. These data suggest favorable tolerability and
encouraging activity in patients with AML, and we look forward to
determining the recommended dose for IMGN779 and moving quickly
into later-stage development.”
Preclinical data for IMGN779 were also presented at EHA showing
the agent is highly active in multiple AML xenograft models and is
well-tolerated in preclinical repeat dosing regimens. Findings from
the preclinical evaluation provided the foundation for the clinical
evaluation of IMGN779 in AML.
Poster Details
Title: Initial results from a first-in-human study of
IMGN779, a CD33-targeting antibody-drug conjugate (ADC) with novel
DNA alkylating activity, in patients with relapsed or refractory
AMLAbstract: P526
Title: Designing the next generation CD33-targeting ADC:
IMGN779, selected for potency, novel mechanism and preclinical
tolerability, with high activity in disseminated AML models and
multi-dose regimensAbstract: P562
Additional information - including the full abstracts - can be
found at www.ehaweb.org.
About ImmunoGen, Inc.
ImmunoGen is a clinical-stage biotechnology company that
develops targeted cancer therapeutics using its proprietary ADC
technology. ImmunoGen's lead product candidate, mirvetuximab
soravtansine, is in 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, Debiopharm, Lilly, Novartis, Sanofi and
Takeda. More information about the Company can be found at
www.immunogen.com.
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, 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 is the first antibody drug conjugate (ADC) to utilize
one of ImmunoGen's new family of indolino-benzodiazepine
cancer-killing agents known as IGNs. IMGN779 is comprised of 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
Indolino-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-alkylating IGNs 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.
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 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 six-month transition period ended
December 31, 2016 and other reports filed with the Securities and
Exchange Commission.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170626005321/en/
For InvestorsThrust IRMonique Allaire,
617-895-9511monique@thrustir.comorFor MediaFTI Consulting,
Inc.Robert Stanislaro,
212-850-5657robert.stanislaro@fticonsulting.com
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