FDA has provided the breakthrough therapy status based on data from the BPDCN cohort of the first-in-human study of IMGN632, said ImmunoGen.
IMGN632 is a CD123-targeting ADC, which is under clinical development for haematological malignancies such as BPDCN, acute myeloid leukaemia (AML) and acute lymphocytic leukaemia (ALL).
At present, IMGN632 is being studied in multiple cohorts such as monotherapy for patients with BPDCN and minimal residual disease positive (MRD+) AML following frontline induction therapy, as well as in combinations with Vidaza (azacitidine) and Venclexta (venetoclax) for patients with relapsed/refractory AML.
IMGN632 is said to use one of ImmunoGen’s novel indolino-benzodiazepine (IGN) payloads that alkylate DNA without crosslinking. The company has designed IGNs to provide high potency against AML blasts.
ImmunoGen president and CEO Mark Enyedy said: “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.
“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 haematological malignancies.”
Separately, AstraZeneca has secured a breakthrough therapy designation (BTD) from the FDA for Farxiga (dapagliflozin) in chronic kidney disease (CKD) patients, with and without type 2 diabetes (T2D).
Farxiga is an oral, once-daily sodium-glucose co-transporter-2 inhibitor (SGLT2 inhibitor). Its breakthrough therapy designation in chronic kidney disease was driven by the findings of phase 3 DAPA-CKD trial.