On October 16, 2017 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that the U.S. Food and Drug Administration (FDA) has completed the safety review of its investigational new drug (IND) application for IMGN632 in patients with CD123-positive hematological malignancies, including acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN) (Press release, ImmunoGen, OCT 16, 2017, View Source [SID1234520942]). Filed in mid-September, the IND is now in effect and ImmunoGen plans to open a Phase 1 study to enrollment before the end of the year.
“IMGN632 is the second ADC from our pipeline to use one of ImmunoGen’s indolino-benzodiazepine cancer-killing agents known as IGNs”
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“IMGN632 is the second ADC from our pipeline to use one of ImmunoGen’s indolino-benzodiazepine cancer-killing agents known as IGNs,” said Richard Gregory, Ph.D., Executive Vice President and Chief Scientific Officer of ImmunoGen. “Our 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. Based on the encouraging preclinical findings, IMGN632 represents a potentially promising therapeutic approach for a range of hematological malignancies and we are working to transition this compound rapidly into clinical development before the end of the year.”
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 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting show that IMGN632, which alkylates DNA, had potent selective activity against AML cells with lower cytotoxicity to normal myeloid progenitor cells than an ADC designed to crosslink DNA activity. These data suggest IMGN632 has the potential to be a highly effective, yet tolerable ADC for AML patients. Supporting preclinical data for IMGN632 showed compelling activity in AML xenograft models.
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 U.S. alone, 21,380 patients will be diagnosed with AML this year and 10,590 patients will die from the disease.