IRVINE, Calif., January 4, 2020 – Bioniz Therapeutics, Inc., (“Bioniz”), a clinical-stage biopharmaceutical company advancing a pipeline of first-in-class peptide-based multi-cytokine inhibitors for the treatment of cancer and autoimmune diseases, announced today that the U.S. Food and Drug Administration (FDA) provided positive feedback during the company’s end of Phase 2 (EOP2) meeting for Bioniz’s BNZ-1. Based on the FDA’s feedback, Bioniz intends to initiate a Phase 3 clinical trial of BNZ-1 for the treatment of patients with relapsed or refractory cutaneous T-cell lymphoma (rCTCL). The FDA provided clear guidance for the design of the BNZ-1 Phase 3 trial as well as submission of the New Drug Application (NDA) that would follow a successful pivotal trial. Bioniz expects the phase 3 to begin enrolling second half of 2021. BNZ-1 has previously been granted orphan designation by the FDA.
“The successful completion of our end of Phase 2 meeting with the FDA for BNZ-1 is another key milestone for this drug, which is the lead candidate from our platform of novel multi-cytokine inhibitors designed to treat cancer and autoimmune diseases driven by unregulated T-cell biology,” said Dr. Nazli Azimi, Founder, President, and CEO of Bioniz Therapeutics and co-inventor of BNZ-1. “Based on the feedback from the FDA and the data from our recently completed Phase 1/2 clinical study, we believe BNZ-1 can be a major advancement in helping CTCL patients stabilize their disease without significant and treatment-limiting side effects.”
Bioniz recently reported positive clinical data in an oral presentation at the 62nd ASH Annual Meeting and Exposition (ASH 2020) from the company’s Phase 1/2 clinical study of BNZ-1 for the treatment of patients with rCTCL, a rare, aggressive cancer. BNZ-1, a novel immuno-modulator drug candidate, is a multi-cytokine inhibitor of three interleukins (IL-2, IL-9, and IL-15) and is the lead asset from the company’s platform of first-in-class peptide therapeutics that selectively and simultaneously inhibits multiple cytokines to treat cancer and autoimmune diseases.
About Refractory Cutaneous T-cell Lymphoma (rCTCL)
Cutaneous T-cell lymphomas (CTCLs) are a rare, aggressive, heterogeneous group of non-Hodgkin’s lymphomas that manifest primarily in the skin. Although a wide array of therapeutic options are available for early-stage CTCL, not all patients respond, resulting in refractory CTCL (rCTCL) with limited treatment options and a poor prognosis.
The company’s lead product candidate, BNZ-1, is a selective inhibitor of cytokines IL-2, IL-9, and IL-15, which are potent T-cell growth factors and key disease drivers in CTCL. Bioniz is also evaluating BNZ-1 for the treatment of autoimmune diseases, including alopecia areata and vitiligo, which are also driven by unregulated T-cell biology.
About Bioniz Therapeutics
Bioniz Therapeutics is a clinical-stage biopharmaceutical company advancing a pipeline of first-in-class peptide-based multi-cytokine inhibitors for the treatment of cancer and autoimmune diseases. Bioniz leverages its world class expertise in cytokine biology to develop a novel approach to selectively inhibit functionally redundant cytokines while leaving the rest of the cytokine network intact. For more information, please visit www.bioniz.com.
Kevin Green, SVP Corporate Development
Jessica Yingling, Ph.D.
Little Dog Communications Inc.