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

IRVINE, Calif., May 1, 2018 /PRNewswire/ -- Bioniz Therapeutics, Inc., a clinical stage biopharmaceutical company developing first-in-class peptide therapeutics that selectively and simultaneously inhibit multiple cytokines to treat immuno-inflammatory diseases and cancer, today 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."

Bioniz plans to present the study data at two upcoming scientific meetings.

• Dr. Nazli Azimi, President and CEO of Bioniz Therapeutics, will make an oral presentation at the 2018 American Hair Research Summit in Orlando, FL on May 18 at 12:00 pm ET. The title of the presentation is "Translational: Peptide Inhibitors of gamma-chain signaling."
• Additionally, Dr. Paul Frohna will present the full study results at the 2018 International Investigative Dermatology Meeting in Orlando, FL on May 17 at 11:45 am – 1:45 pm ET through a Late-Breaking Poster (LB1517). The title of the poster is "Clinical effects of BNZ-1, a selective inhibitor of IL-2/IL-9/IL-15 in development of alopecia areata."

About BNZ-1
The Company's lead development candidate, BNZ-1, is a PEGylated peptide that functions as a selective and simultaneous inhibitor of cytokines IL-2, IL-9, and IL-15. The company is currently investigating BNZ-1 in a Phase 1 /2 clinical study (NCT03239392) for the treatment of the T-cell malignancies Large Granular Lymphocytic Leukemia (LGL) and refractory Cutaneous T-Cell Lymphoma (CTCL). BNZ-1 has completed two Phase 1 studies in healthy volunteers and the company plans to initiate further clinical trials of BNZ-1 in for the treatment of Alopecia Areata.

About Alopecia Areata
Alopecia Areata (AA) is a common, inflammatory, immune-mediated hair loss that results in partial or complete loss of hair on the scalp and body. The scalp is the most commonly affected area, but any hair-bearing site can be affected alone or together with the scalp. Onset of the disease can occur throughout life and affects both women and men. Among the US population, the cumulative lifetime incidence of AA is estimated at 2%, while the prevalence is estimated to be 0.1 to 0.2%. The cause(s) of AA is believed to result from a loss of immune privilege in the hair follicle following a triggering event, autoimmune-mediated hair follicle destruction, and the upregulation of inflammatory pathways. The immune pathways in AA involve cytokines IL-2, IL-9 and IL-15, which have been shown to be upregulated in animal models of AA and in human biopsies of AA lesions (Xing 2014; Suarez-Farinas 2015).

There are currently no drugs approved by the U.S. Food and Drug Administration (FDA) for the treatment of AA.

About Bioniz

Bioniz is a clinical-stage biopharmaceutical company developing first-in-class multi-cytokine inhibitory peptide therapeutics to address immuno-inflammatory diseases and T-cell malignancies. Bioniz leverages its world class expertise in cytokine biology to develop a novel approach to selectively inhibit functionally redundant cytokines while leaving the rest of the cytokine network intact. Bioniz' innovative platform has resulted in multiple peer-reviewed publications in notable scientific journals. Bioniz is developing a robust pipeline of product candidates in multiple autoimmune and oncology indications. The Company's lead product candidate, BNZ-1, has been successfully studied in two Phase 1 studies in healthy volunteers where it demonstrated a favorable safety profile and exposure-dependent pharmacodynamic activity, and is currently investigated in a Phase 1 /2 clinical study (NCT03239392) in Granular Lymphocytic Leukemia (LGL) and Cutaneous T-Cell Lymphoma (CTCL).
For more information, please visit www.bioniz.com.

SOURCE Bioniz Therapeutics, Inc.