The FDA accepts an investigational new drug application for NX-2127 for R/R B-cell malignancies

On February 16, 2021, it was announced that the U.S. Food and Drug Administration (FDA), accepted an investigational new drug application for NX-2127 for the treatment of relapsed or refractory (R/R) B-cell malignancies, including chronic lymphocytic leukemia.¹

NX-2127 is an oral, first-in-class, targeted protein degrader of Bruton’s tyrosine kinase (BTK), with immunomodulatory drug activity. The acceptance of the application was based on preclinical data presented at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, in which NX-2127 was shown to: potently and selectively degrade both wild type and ibrutinib-resistant mutant BTK in lymphoma cell lines; activate normal human T cells with a similar potency to the commercially available immunomodulatory drugs, pomalidomide and lenalidomide; demonstrate potent antitumor effects in mouse xenograft models; and induce rapid and near complete BTK degradation in non-human primates with once-daily dosing.^1,2

The phase Ia/b trial of NX-2127 in patients with R/R B-cell malignancies is due to start in the first quarter of 2021.¹