Bioniz Therapeutics Initiates Phase 1/2 Clinical Study of BNZ‑1 in T-Cell Leukemia and Lymphoma

IRVINE, Calif., April 4, 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 T-cell malignancies, today announced that it has initiated a Phase 1/2 open-label clinical study of its lead product candidate BNZ-1 in patients with Large Granular Lymphocyte Leukemia (LGL) or refractory Cutaneous T-Cell Lymphoma (rCTCL).  BNZ-1 is a multi-cytokine inhibitor targeting interleukin (IL)-2, IL-9, and IL-15, that has been successfully studied in two Phase 1 studies in healthy volunteers where it demonstrated a favorable safety profile and exposure-dependent pharmacodynamic activity.

The Phase 1/2, multi-center, open-label, dose-escalation clinical study of BNZ-1 is designed to assess the safety and activity of BNZ-1 in up to 24 patients with LGL and rCTCL. BNZ-1 will be given as a single agent and will be administered weekly in 3 dose cohorts. Key objectives of the study include characterizing the safety profile, the exposure-response (PK-PD) relationship, and the clinical activity of BNZ-1. The primary endpoint is overall safety after 4 weeks of treatment. The study includes a 3-month treatment extension for all patients to further evaluate safety and clinical response.  The study is enrolling patients at Ohio State University, the University of Virginia, Moffitt Cancer Center and City of Hope Cancer Center. More information about this study can be found at www.clinicaltrials.gov, Identifier NCT03239392.

"Together with our investigators, we are eager to characterize the potential clinical benefit of BNZ-1 in patients with LGL or rCTCL," said Dr. Paul Frohna, Chief Medical Officer of Bioniz Therapeutics. "Evaluating BNZ-1 in these patients serves as an important first step in our efforts to characterize the potential of BNZ-1 across a wide range of T-cell malignancies where IL-2/9/15 are implicated as disease drivers."

"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 United States." said Dr. Jonathan Brammer, M.D., hematologist at The James Cancer Center at the Ohio State University and lead investigator of the study.

About T-Cell Leukemia and Lymphoma
"Leukemia" and "lymphoma" refers to cancers of white blood cells or lymphocytes, which are key components of the immune system. T-cell leukemia and lymphoma include a group of rare and often aggressive diseases, including LGL and CTCL with no FDA-approved (LGL) or limited treatment options and a poor prognosis.  Bioniz' product candidate BNZ-1 is a selective inhibitor of cytokines IL-2, IL-9, and IL-15, which are potent T-cell growth factors and key disease drivers in these T-cell malignancies. 

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. With a dual mechanism of action, BNZ-1 blocks tumor proliferation and survival signals, and unleashes the patient's internal immune response to help fight the cancer by reducing the number and activity of regulatory T‑cells. The company has completed two Phase 1 studies with BNZ-1 in healthy volunteers and is currently enrolling a Phase 1/2 clinical study for the treatment of LGL and rCTCL (NCT03239392). The company also plans to investigate BNZ-1 for the treatment of moderate to severe Alopecia Areata.

About Bioniz
Bioniz is a clinical-stage biopharmaceutical company developing first-in-class multi-cytokine inhibitors for the treatment of T-cell malignancies and immuno-inflammatory diseases. 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.
For more information, please visit www.bioniz.com.

SOURCE Bioniz Therapeutics, Inc.

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