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ImmunoGen Announces Investigational New Drug Application for IMGN632 for Hematological Malignancies is ActiveImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced 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). 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 (News - Alert) 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) 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 potentil 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
About IGNs
About Acute Myeloid Leukemia (AML) 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.4
About ImmunoGen, Inc. Kadcyla® is a registered trademark of Genentech, a member of the Roche Group.
1 S. Adams et al, Abstract 2832, Presented at
the American Society of Hematology, December 3-6, 2016. 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 (News - Alert) for the six-month transition period ended December 31, 2016 and other reports filed with the Securities and Exchange Commission.
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