Bioniz Therapeutics has announced positive data from a phase 1/2 clinical trial of BNZ-1 for the treatment of relapsed or refractory cutaneous T-cell lymphoma (rCTCL).
BNZ-1 is an immuno-modulator drug candidate. It is a multi-cytokine inhibitor of three interleukins, that includes IL-2, IL-9, and IL-15.
It is the lead asset from Bioniz Therapeutics’ platform of first-in-class peptide therapeutics that inhibit selectively and simultaneously multiple cytokines for treating cancer and autoimmune diseases.
Dr. Nazli Azimi – Founder, President, and CEO of Bioniz Therapeutics and co-inventor of BNZ-1, said: “These data validate our platform technology with the first efficacy demonstration of BNZ-1, a novel multi-cytokine inhibitor, and assisted us in the design of a pivotal clinical trial for CTCL, which the company expects to begin in 2021.
“We believe the efficacy of BNZ-1 in rCTCL, a challenging and progressive disease, is due to the drug’s multi-modal mechanism of action. BNZ-1 was specifically designed as a multi-cytokine inhibitor to integrate inhibition of malignant cells, activation of tumor immunity, and suppression of inflammation.
“In addition to the positive efficacy data, we are extremely encouraged that the BNZ-1 treatment was well tolerated, which could support long-term treatment for these patients.”
The phase 1/2 clinical trial was designed as a multi-center, open-label, dose-escalation study of BNZ-1 to evaluate its safety and activity as a single systemic agent in rCTCL patients who failed the standard of care and other available treatment options, which include up to seven prior skin-directed and systemic therapies.
The primary endpoint of the early-stage trial was overall safety following four weeks of treatment. There was a three-month treatment extension to assess the safety and clinical response further at week 17.