Bioniz Therapeutics Reports Top-Line Phase 1 Clinical Study Results for BNZ-1, A Novel Multi-Cytokine Inhibitor

-- Favorable Safety, Pharmacokinetics and Robust Pharmacodynamic Activity Demonstrated in Healthy Volunteers –

IRVINE, CA, USA I July 19, 2017 I Bioniz Therapeutics, Inc., a clinical stage biopharmaceutical company leading the discovery and development of first-in-class peptide therapeutics that selectively and simultaneously inhibit multiple cytokines to treat immuno-inflammatory diseases and T-cell malignancies, today announced top-line results from its first-in-human study of BNZ-1, a novel IL-2/IL-9/L-15 inhibitor.

In the open-label, dose-escalation study (NCT03046459), 18 healthy volunteers were administered a single intravenous dose of BNZ-1 ranging from 0.2 mg/kg to 6.4 mg/kg followed by 30 days of safety monitoring and collection of pharmacokinetic and biomarker samples. BNZ-1 was well-tolerated and generally considered safe, without any clinically significant laboratory abnormalities or dose limiting toxicities observed at any dose level. Bioniz Therapeutics plans to report detailed results from this Phase 1 study at an upcoming scientific conference.

"The Phase 1 study results demonstrate that BNZ-1 has a favorable safety and tolerability profile while producing sustained, dose-dependent pharmacodynamic effects that demonstrate multi-target engagement in healthy volunteers," said Paul Frohna, MD, PhD, PharmD, Senior Vice President of Clinical Development of Bioniz Therapeutics. "We are highly encouraged by these Phase 1 results, and are looking forward to launching the next clinical studies of BNZ-1 over the next few months."

Bioniz will initiate a multiple ascending dose study of BNZ-1 in healthy volunteers in Q3 2017 and plans to conduct future clinical trials of BNZ-1 in multiple patient populations, including the T-cell malignancies of Large Granular Lymphocyte Leukemia (LGL) and Cutaneous T-cell Lymphoma (CTCL), as well as for autoimmune indications, including Alopecia Areata.

"These encouraging data validate our scientific hypothesis and support our plans for further development of BNZ-1 for the treatment of patients who have diseases with highly unmet medical needs," said Nazli Azimi, PhD, Co-Founder, President and CEO of Bioniz Therapeutics.

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 currently plans to develop BNZ-1 for the treatment of the T-cell malignancies LGL and CTCL, as well as for the autoimmune disease Alopecia Areata.

About Bioniz
Bioniz is a clinical-stage biopharmaceutical company leading the discovery and development of first-in-class multi-cytokine inhibitory peptide therapeutics to address immuno-inflammatory diseases and cancer. Bioniz leverages its world class expertise in cytokine biology, originating in research conducted at the National Institutes of Health (NIH), 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' lead product candidate, BNZ-1, has completed a Phase 1 clinical trial in healthy volunteers. For more information, please visit www.bioniz.com.

SOURCE: Bioniz

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