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
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
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
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.
3 Y. Kotvun et al. (2016) Blood 128:768.
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
FTI Consulting, Inc.
Robert Stanislaro, 212-850-5657
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