FDA Grants Breakthrough Therapy Designation to IMGN632 for BPDCN

October 5, 2020

The FDA granted breakthrough therapy designation to IMGN632 for the treatment of patients with relapsed or refractory blastic plasymacytoid dendritic cell neoplasm.

The FDA has granted breakthrough therapy designation to IMGN632 for the treatment of patients with relapsed or refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN).

IMGN632 is a CD123-targeting antibody drug conjugate (ADC) in clinical development for hematological malignancies, including BPDCN, acute myeloid leukemia (AML), and acute lymphocytic leukemia (ALL). The breakthrough therapy designation was granted based on the findings from the BPDCN cohort of the first-in-human study of IMGN632, for which initial data were presented in an oral session at the American Society of Hematology (ASH) Annual Meeting in 2019

Updated data from the IMGN632 monotherapy BPDCN dose expansion cohort will be presented at ASH this December.

“We are pleased FDA has granted Breakthrough Therapy designation for IMGN632, our novel CD123-targeted ADC, as it underscores the urgent need for effective and well-tolerated treatments for patients with this rare and aggressive cancer,”Mark Enyedy, president and chief executive officer at ImmunoGen, said in a press release. “We look forward to continuing to work with FDA to further define the development path for IMGN632 in BPDCN, in addition to pursuing our ongoing evaluation of IMGN632 in AML and other hematological malignancies.”

IMGN632 uses one of the company's novel indolino-benzodiazepine (IGN) payloads, which alkylate DNA without crosslinking. IGNs have been designed to have high potency against AML blasts, while simultaneously affording less toxicity to normal marrow progenitors than other DNA-targeting payloads.

Currently, the agent is being evaluated in multiple cohorts, including as monotherapy for patients with BPDCN and minimal residual disease-positive AML following frontline induction therapy and in combinations with azacitidine (Vidaza) and venetoclax (Venclexta) for patients with relapsed or refractory AML.

Reference:

ImmunoGen Announces FDA Breakthrough Therapy Designation for IMGN632 in Relapsed or Refractory Blastic Plasmacytoid Dendritic Cell Neoplasm [news release]. Walham, Massachusetts. Published October 5, 2020. Accessed October 5, 2020. https://investor.immunogen.com/news-releases/news-release-details/immunogen-announces-fda-breakthrough-therapy-designation-imgn632