Second ADC Using ImmunoGen’s Novel
DNA-Alkylating Payloads to Enter the Clinic
ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field
of antibody-drug conjugates (ADCs) for the treatment of cancer,
today announced that the first patient has been treated with
IMGN632 in a Phase 1 clinical trial of patients with CD123-positive
hematological malignancies, including acute myeloid leukemia (AML)
and blastic plasmacytoid dendritic cell neoplasm (BPDCN).
IMGN632 uses ImmunoGen's novel indolino-benzodiazepine payload,
DGN549, which alkylates DNA without crosslinking, as well as novel
linker technology with a CD123-targeting antibody. In preclinical
studies with IMGN632, ImmunoGen has reported potent and selective
activity against AML cells with lower cytotoxicity to normal
myeloid progenitor cells than an ADC designed to crosslink DNA.1
Supporting preclinical data for IMGN632 have also shown compelling
activity in AML and acute lymphoblastic leukemia (ALL) models with
single and multi-dose regimens.2,3 These data suggest that IMGN632
has the potential to be a highly effective, yet tolerable ADC.
“We continue to rapidly advance our novel IGN portfolio in a
number of hematological malignancies and are pleased to be moving
our second IGN ADC, IMGN632, into the clinic,” said Anna
Berkenblit, M.D., VP and Chief Medical Officer of ImmunoGen. “Our
IGN payloads were developed to meet the dual challenges of
achieving high potency against target cells, while enabling
continued patient treatment. We believe IMGN632 has the potential
to be a highly effective therapy with favorable tolerability for
the treatment of patients with CD123-positive hematologic
malignancies, including AML and BPDCN, cancers where new therapies
are desperately needed.”
The Phase 1 trial in AML and BCPDN will follow a once every
three week dosing schedule while in its dose-finding stage. The
selected dose will then be used in expansion cohorts assessing
IMGN632 in patients with BPDCN, AML, ALL, and other CD123-positive
hematologic malignancies.
“We are excited to be leading off the clinical evaluation of
IMGN632, a potential new treatment option for patients with
CD123-positive hematologic malignancies,” said Hagop M. Kantarjian,
M.D., professor and chair of the Department of Leukemia at the
University of Texas MD Anderson Cancer Center and principal
investigator of the trial of IMGN632.
Data presented at the American Society of Hematology Annual
Meeting (ASH) 2017 demonstrated promising activity and safety with
IMGN632 in preclinical models of B-cell ALL (B-ALL).4 CD123
expression is prevalent across ALL subtypes, including 90% of B-ALL
and nearly half of T-cell acute lymphoblastic leukemia. IMGN632
demonstrated promising activity against B-ALL cell lines and
patient samples in vitro, including the elimination of more than
90% of B-ALL blasts in 6 out of 8 patient samples. Normal cells
were not affected by IMGN632 at 100-fold higher concentrations.
This is the second clinical trial using IGNs, a new class of
cancer-killing agents developed by ImmunoGen for use in ADCs.
ImmunoGen recently reported findings from the Company’s ongoing
Phase 1 study of IMGN779 in patients with relapsed or refractory
adult AML whose tumors express CD33.5 The data demonstrate that
IMGN779 is well-tolerated with no dose-limiting toxicities,
pharmacokinetic exposures and pharmacodynamic CD33 saturation
increasing with dose, and anti-leukemia activity observed in
patients with poor prognostic features.
About IMGN632IMGN632 is a humanized anti-CD123 ADC that
is a potential treatment for AML, BPDCN, myelodysplastic syndrome,
B-cell ALL and other CD123-positive malignancies. IMGN632 uses a
novel IGN payload, linker and antibody technology, and has
demonstrated potent and selective activity, with minimal cytotoxic
effects, in preclinical models of AML and ALL.6,7
About IGNsIndolino-benzodiazepine agents, or IGNs, are a
new class of cancer-killing agent developed by ImmunoGen for use in
ADCs. 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.
These ultra-potent, DNA-acting IGNs alkylate DNA without
crosslinking, which preclinically has resulted in potent
anti-leukemia activity with relative sparing of healthy
cells.8,9
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.10
About Blastic Plasmacytoid Dendritic Cell Neoplasm
(BPDCN)
BPDCN is a disease of the bone marrow and blood that affects
multiple organs, including the lymph nodes and the skin. It often
presents as leukemia or lymphoma. There are little data about BPDCN
and there is no established treatment. The average age
at diagnosis is 60 to 70 years. There are more men than
women who are diagnosed with BPDCN.11,12
About ImmunoGen, Inc.ImmunoGen is a late-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 Y. Kovtun et al, Abstract 768, Presented at
the American Society of Hematology, December 3-6,
2016.2 S. Adams et al, Abstract 2832, Presented at
the American Society of Hematology, December 3-6,
2016.3 E. Angelova et al, Abstract 2718, Presented at the
American Society of Hematology, December 9-12,
2017.4 Angelova, 2017.5 J. Cortes et al, Abstract 1312,
Presented at the American Society of Hematology, December 9-12,
2017.6 Kovtun, 2016.7 Angelova, 2017.8 Kovtun,
2016.9 M. Miller et al. (2016) Mol Cancer Ther
15:1870-78.10 American Cancer Society (2016), About Acute
Myeloid Leukemia.11 Clinical Advances in Hematology &
Oncology Volume 14, Issue 4 April 201612 Leukemia &
Lymphoma Society (2018), Blastic Plasmacytoid Dendritic Cell
Neoplasm.
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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version on businesswire.com: http://www.businesswire.com/news/home/20180104005181/en/
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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