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.

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As part of the trial, BNZ-1 will be provided as a single agent given weekly in three dose cohorts.

“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.”

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.

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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.