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Interim data from the phase I/II study on BNZ-1 in patients with refractory cutaneous T-cell lymphoma

Jul 24, 2020

On July 20, 2020, positive interim clinical data from the phase I/II study of BNZ-1 in patients with refractory cutaneous T-cell lymphoma (rCTCL) were announced.

BNZ-1 is a selective multi-cytokine inhibitor targeting interleukin (IL)-2, IL-9, and IL-15, which has demonstrated a favorable safety profile in two phase I studies in healthy volunteers. A phase I/II dose-escalation study (NCT03239392) is currently investigating the safety and activity of BNZ-1 in patients with rCTCL.

Patients with rCTCL, who had failed standard of care and other available treatment options, were treated with BNZ-1 across four different doses of 0.5, 1, 2, and 4 mg/kg for intravenous weekly dosing. The primary endpoint was overall safety after 4 weeks. There was a 3-month treatment extension to further evaluate the safety and efficacy. BNZ-1 was well tolerated with no dose limiting toxicities. The 2 mg/kg cohort included 19 patients with rCTCL, who had failed a median of seven prior skin-directed and systemic therapies, and demonstrated a clinical response, with

• over 80% of patients showing some improvement in tumor burden, assessed by the modified severity-weighted assessment tool (mSWAT) score

• about half achieving a partial response in the mSWAT score, and 5% achieving a complete response

• a mean duration of response of 277 days (9.2 months) in responding patients at the time of the data cutoff

Based on the outcomes of the phase II study, a phase III study could start in the first half of 2021.

  1. Bioniz Therapeutics. Bioniz announces positive efficacy and safety data for BNZ-1 from interim analysis of phase 1/2 study in cutaneous T-cell lymphoma. Published Jul 20, 2020. Accessed Jul 22, 2020.