Bioniz Therapeutics has commenced a Phase I/II clinical trial evaluating the safety and activity of BNZ-1 to treat patients with Large Granular Lymphocyte Leukemia (LGL) or refractory Cutaneous T-Cell Lymphoma (rCTCL).
The dose-escalation trial will enrol up to 24 patients with LGL and rCTCL.
As part of the trial, BNZ-1 will be provided as a single agent given weekly in three dose cohorts.
The trial’s major objectives include characterising the safety profile, the exposure-response (PK-PD) relationship, and the clinical activity of BNZ-1. Its primary endpoint is overall safety after four weeks of treatment.
In addition, the trial features a three-month treatment extension for all patients to further analyse the safety and clinical response of BNZ-1.
The study is set to enrol patients at various institutes across the US, including Ohio State University, the University of Virginia, Moffitt Cancer Center and City of Hope Cancer Center.
The study lead investigator Dr Jonathan Brammer said: “BNZ-1 holds great potential as a new therapy for LGL and relapsed CTCL as its novel mechanism of action addresses a critical driver in both these diseases, IL-15, while also inhibiting the associated cytokines IL-2 and IL-9.
“The results from this study will help determine if BNZ 1 has promise as a new treatment option for patients who currently have no or few alternatives, and is the only active study specifically designed to target LGL in the US.”
BNZ-1 is a multi-cytokine inhibitor targeting interleukin (IL)-2, IL-9, and IL-15, and has previously proved its potential in two Phase I studies conducted on healthy volunteers. In those studies, it showed a favourable safety profile and exposure-dependent pharmacodynamic activity.
