Bioniz Therapeutics Announces Positive Phase 1b Clinical Study Results for Investigational Agent BNZ-1

Bioniz Therapeutics announced top-line results from its multiple ascending dose Phase 1b clinical trial of BNZ-1, a novel multi-cytokine inhibitor targeting interleukin (IL)-2, IL-9, and IL-15. Bioniz is currently investigating BNZ-1 in an ongoing Phase 1 / 2 clinical trial in the T-cell malignancies Large Granular Lymphocyte Leukemia (LGL) and refractory Cutaneous T-cell Lymphoma (rCTCL), and the company now plans to develop BNZ-1 in additional patient populations, including the autoimmune disease Alopecia Areata (AA).

The Phase 1b study (NCT03239379) was a randomized, single-blind, placebo-controlled, study to characterize the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of a range of multiple doses of intravenous BNZ-1 administered to healthy adult subjects. Three weekly dose cohorts were investigated (n=5/cohort; 0.5, 1 and 1.5 mg/kg/wk x 4 doses) and two every other weekly dose cohorts were investigated (n=5/cohort; 2 and 3 mg/kg/wk x 3 doses), in a dose escalation manner. No serious or severe adverse events (AEs), infusion-related reactions, or dose limiting laboratory toxicities were observed. The rate of adverse events was comparable between the pooled BNZ-1 and pooled Placebo groups. Sore throat and runny nose were the only two common adverse events (reported in >1 subject) that occurred more frequently in the overall BNZ-1 group, as compared to the pooled Placebo group. Adverse events did not appear to be dose/exposure-related. A total of 53 healthy adult volunteers have now been dosed with BNZ-1 across two Phase 1 studies with no dose limiting side effects, infusion reactions, or serious/severe adverse events observed. The overall Phase 1 safety profile supports continued clinical development of BNZ-1.

The pharmacodynamic (PD) results suggest that all tested dosing regimens of BNZ-1 were highly active and selectively produced an exposure-related reduction from baseline in NK cells, Tregs, and CD8+ central-memory T cells (Tcm), which demonstrate a specific target engagement of blocking IL-2 and IL-15. All PD effects returned back to/towards baseline following the discontinuation of dosing, while total, CD4+ and CD8+ T-cells, B-cells and monocytes were unaffected across the range of doses tested. The Phase 1b PD results are consistent with the selective PD effects observed in the previous single ascending dose study of BNZ-1.

“This Phase 1b study further characterizes BNZ-1’s encouraging safety and tolerability profile while producing sustained, dose-dependent, and highly IL-2/15-specific pharmacodynamic effects with multiple dosing,” said Paul Frohna, MD, PhD, PharmD, Chief Medical Officer of Bioniz Therapeutics. “These results establish initial clinical validation of BNZ-1’s potential to treat a variety of IL-2/9/15 cytokine-driven conditions with a novel mechanism.” Dr. Frohna continued, “We now look forward to investigating BNZ-1 in multiple patient populations, including Alopecia Areata, where we believe BNZ-1 may provide advantages over currently available therapies.”