ImmunoGen Announces Investigational New Drug Application for IMGN632 for Hematological Malignancies is Active
"IMGN632 is the second ADC from our pipeline to use one of ImmunoGen's
indolino-benzodiazepine cancer-killing agents known as IGNs," said
IMGN632 uses ImmunoGen's novel DGN549 IGN payload, linker, and antibody
technology and in preclinical models has demonstrated an impressive
therapeutic window against CD123-positive malignancies. Preclinical
findings reported at the 58th
About IMGN632
IMGN632 is a humanized anti-CD123
antibody-drug conjugate that is a potential treatment for AML, BPDCN,
myelodysplastic syndrome, B-cell acute lymphocytic leukemia, and other
CD123-positive malignancies. IMGN632 uses a novel IGN payload, linker
and antibody technology and in AML xenograft models has demonstrated a
large therapeutic index.1
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-acting IGNs alkylate DNA without
crosslinking, which preclinically has resulted in potent anti-leukemia
activity with relative sparing of normal hematopoietic progenitor cells.2,3
IMGN779, a CD33-targeting ADC in Phase 1 testing for AML, was the first
IGN ADC to enter clinical testing.
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
About
ImmunoGen is a clinical-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,
Kadcyla® is a registered trademark of
1 S. Adams et al, Abstract 2832, Presented at
the American Society of Hematology, December 3-6, 2016.
2 S.
3 Y.
Kotvun et al. (2016) Blood 128:768.
4
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
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