ImmunoGen Inc. (NASDAQ:IMGN) has announced that it has received Breakthrough Therapy designation from the FDA for IMGN632 in treating relapsed or refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN) patients.
IMGN632 receives Breakthrough Therapy designation
Mark Enyedy, the CEO and president of ImmunoGen, said that they are delighted to receive the Breakthrough Therapy designation from the FDA for their novel CD123-targeted ADC, IMGN632. He said that the award underlines the urgent need to have a well-tolerated and effective treatment for individuals with this aggressive and rare cancer form. Enyedy said that they look forward to continued collaboration with the FDA to further define the development path for the therapy in BPDCN. Besides this, the company is also pursuing its ongoing assessment of IMGN163 in the treatment of AML as well as other hematological malignancies.
It is important to note that the FDA’s Breakthrough Designation is meant for accelerating the drug development and review processes, especially for therapies that have shown the potential of treating serious conditions. Also, the treatment should show from preclinical evidence that it can significantly improve the patient’s condition compared to existing therapies.
Updated data on IMGN632 to be presented in December
The FDA granted ImmunoGen the Breakthrough Therapy designation for IMGN632 based on results from the BPDCN cohort of the first human study of IMGN632. The company presented the initial data in an oral session in the 2019 Annual Meeting of the American Society of Hematology (ASH). ImmunoGen will present updated data from the IMGN632 dose expansion group in December at ASH.
IMGN632 is ImmunoGen’s CD123-targeting ADCthat is in clinical development for the treatment of PBDCN, acute lymphocytic leukemia, and acute myeloid leukemia. It is currently under evaluation in multiple cohorts that include monotherapy for BPDCN patients and minimal residual positive AML after frontline induction therapy. The company is also evaluating it in combination with Venclexta® and Vidaza® in relapsed or refractory AML patients. The therapy employs the company’s proprietary indolino-benzodiazepine payloads that alkylate DNA without cross-connecting, thus offering enhanced potency against AML blasts and exhibiting less toxicity to standard marrow progenitors.