ImmunoGen, Inc. (NASDAQ:IMGN) has announced the completion of the review process for its Investigational New Drug (IND) Application for IMGN632 by the Food and Drug Administration (FDA).
The recent announcement made by the biopharma on Monday revealed that the FDA has finalized its safety review of the IND application for IMGN632 as a pipeline treatment for those who have CD123-positive hematological malignancies. This includes those suffering from blastic plasmacytoid dendritic cell neoplasm (BPDCN) and acute myeloid leukemia (AML). ImmunoGen filed for the IND review by the FDA in September and the company now plans to pursue a phase 1 study to enrollment before the end of 2017.
“IMGN632 is the second ADC from our pipeline to use one of ImmunoGen’s indolino-benzodiazepine cancer-killing agents known as IGNs,” stated Richard Gregory, the executive VP and Chief Scientific Officer at Immunogen.
Gregory further added that his company’s IGN payloads are designed to handle and meet the challenges of maintaining high potency against the target cells while also maintaining tolerance levels that facilitate continued treatment of patients. The VP also stated that IMGN632 looks promising as a therapeutic treatment against various hematological malignancies based on preclinical findings. Gregory also revealed that ImmunoGen is working towards rapidly moving the investigative treatment into clinical development within the next few months, preferably before the end of 2017.
The investigative pipeline treatment takes advantage of the company’s antibody technology, linker and novel DGN549 IGN payload. ImmunoGen researchers were able to observe an impressive therapeutic window against CD123-positive malignancies during the preclinical models of IMGN632. The biopharma reported the preclinical findings of the investigative treatment during the annual meeting at the 58th American Society of Hematology (ASH).
The report indicated that IMGN632 demonstrated strong selective capacity against AML cells that have lower cytotoxicity compared with the myeloid progenitor cells. Additionally, IMGN632 was seen to perform even better than an ADC which is engineered to crosslink DNA activity. These findings suggest that the treatment is potentially highly effective while still managing to be tolerable in AML patients.
ImmunoGen stock closed the latest trading session on Monday at $6.00 after a 0.5 percent gain compared to the previous closing price.
