Characterization of a Novel, Multi-Cytokine Inhibitor, BNZ-1, for the Treatment of T-cell Malignancies and Alopecia Areata
Nazli Azimi
Founder, President and CEO, Bioniz Therapeutics
Bioniz is a peptide-therapeutic company developing of first-in-class multi-cytokine inhibitors for the treatment of cancer and autoimmune diseases. BNZ-1 is a PEGylated selective and simultaneous inhibitor of interleukin (IL)-2, IL-9 and IL-15 signaling through the common gamma-chain (c) cytokine receptor, which is being evaluated clinically for the treatment of T-cell malignancies and alopecia areata. Data from preclinical tumor and immune-mediated hair loss models, and IND-enabling toxicology demonstrate the potential of BNZ-1 as a novel therapeutic approach for these indications. Completed Phase I clinical studies of single and multiple doses in healthy subjects show that BNZ-1 exhibits favorable safety and pharmacokinetic profiles, and target engagement that results in dose-dependent pharmacodynamic effects on certain cell populations of the immune system. These data set the stage for our ongoing phase II clinical study to characterize the safety and efficacy of BNZ-1 in the treatment of patients with Large Granular Lymphocyte (LGL) Leukemia or refractory Cutaneous T-cell Lymphoma (CTCL) (NCT03239392), and the launch of a Phase 2 trial in alopecia areata (AA) in late 2018.
Dr. Azimi is Bioniz’ founder, co-inventor of its core technology, and has served as the Company’s Chief Executive Officer since its inception. Dr. Azimi is a graduate of University of Tehran and recipient of a post-doctoral fellowship program in immunology at one of the premier research groups at the National Institutes of Health (NIH) with a focus on cytokine biology. During her training and later as an independent scientist, she made seminal contributions to the field, and developed the knowledge that later became the foundation for Bioniz’s multi-cytokine inhibitory platform technology. After NIH, Dr. Azimi joined the faculty at the Fred Hutchinson Cancer Research Center, where she studied immune cytokine responses to herpes virus. Prior to founding Bioniz, Dr. Azimi served as founder and CEO of Dermaheal USA, a privately held dermatology company. Dr. Azimi has authored over 30 peer-reviewed, high impact scientific publications and is the inventor of more than a dozen patents, including the Bioniz intellectual property patent estate. She is an advisor to the Dean of Pharmacy School at the Chapman University, and serves on the Board of Beall Center for Innovation and Entrepreneurship at the University of California in Irvine. She is also the recipient of 2017 EY Winning Women.