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Bioniz Therapeutics Provides Results from Multi-Cytokine Inhibitor BNZ-1 Clinical Study.

M2 PHARMA-July 20, 2017-Bioniz Therapeutics Provides Results from Multi-Cytokine Inhibitor BNZ-1 Clinical Study


- Irvine, California-based peptide therapeutics developer Bioniz Therapeutics, Inc. has released top-line results from its first-in-human study of BNZ-1, a novel IL-2/IL-9/L-15 inhibitor, the company said.

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 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 and Cutaneous T-cell Lymphoma, as well as for autoimmune indications, including Alopecia Areata.

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.

Bioniz is a clinical-stage biopharmaceutical company developing multi-cytokine inhibitory peptide therapeutics to address immuno-inflammatory diseases and cancer.

The company leverages its world class expertise in cytokine biology, originating in research conducted at the National Institutes of Health, to develop a novel approach to selectively inhibit functionally redundant cytokines while leaving the rest of the cytokine network intact.

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Publication:M2 Pharma
Article Type:Clinical report
Date:Jul 20, 2017
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