IMGN632 is a CD123-targeting ADC in clinical development for hematological malignancies, including blastic plasmacytoid dendritic cell neoplasm (BPDCN), acute myeloid leukemia (AML), and acute lymphocytic leukemia (ALL). IMGN632 uses one of ImmunoGen’s (the “Company”) novel indolinobenzodiazepine (IGN) payloads, which alkylate DNA without crosslinking. IGNs have been designed to have high potency against tumor cells, while demonstrating less toxicity to normal marrow progenitors than other DNA-targeting payloads.
The European Medicines Agency (EMA) granted orphan drug designation to IMGN632 for the treatment of BPDCN in June 2020; IMGN632 also holds this designation in the US. In October 2020, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for IMGN632 for the treatment of patients with relapsed or refractory BPDCN.
In December 2020, the Company announced that it aligned with FDA on a path to full approval for IMGN632, with an amendment to the ongoing 801 Phase 1/2 study to add a new cohort of up to 20 frontline BPDCN patients, with CR/CRc rate as the primary endpoint. IMGN632 is being evaluated in multiple cohorts, including monotherapy for patients with BPDCN and minimal residual disease positive (MRD+) AML following frontline induction therapy and in combinations with Vidaza® (azacitidine) and Venclexta® (venetoclax) for patients with relapsed/refractory AML.
For more information on IMGN632 clinical trials, visit www.clinicaltrials.gov.
Visit our Publications page to access IMGN632 data presentations from past medical meetings.