Bioniz Therapeutics announced 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.

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.