Bioniz Announces Oral Presentation at ASH 2020 of Positive Clinical Data of BNZ-1 for the Treatment of Refractory Cutaneous T-Cell Lymphoma

IRVINE, Calif., Nov. 5, 2020 /PRNewswire/ -- Bioniz Therapeutics, Inc. ("Bioniz") today announced an oral presentation at the 62nd ASH Annual Meeting and Exposition (ASH 2020) of positive safety and efficacy data from the company's Phase 1/2 clinical study of BNZ-1 for the treatment of refractory cutaneous T-cell lymphoma (rCTCL), a rare, aggressive cancer. These clinical data are the first to demonstrate therapeutic efficacy of BNZ-1, a multi-cytokine inhibitor selectively targeting three interleukins, IL-2, IL-9, and IL-15. In the study, BNZ-1 treatment was well tolerated with no dose-limiting toxicities or drug-related serious side effects. BNZ-1 is the lead asset from the company's platform of first-in-class peptide therapeutics that selectively and simultaneously inhibit multiple cytokines to treat cancer and autoimmune diseases.

About the oral presentation at ASH 2020:
Title: Co-inhibition of IL-2, IL-9 and IL-15 by the novel immunomodulator, BNZ-1, provides clinical efficacy in patients with refractory cutaneous T cell lymphoma in a phase 1/2 clinical trial
Session Number and Name: 624. Hodgkin Lymphoma and T/NK Cell Lymphoma—Clinical Studies: Clinical Studies in T/NK Cell Lymphoma
Presenter: Christiane Querfeld, M.D., Director of the Cutaneous Lymphoma Program at the City of Hope, and principal investigator of the study
Session Date and Time: Saturday, December 5 at 7:30 am to 9:00 am PST

"These are the first data to demonstrate efficacy of BNZ-1, a multi-cytokine inhibitor, in treating cancer, and further validate our therapeutic platform and our pipeline of anti-cytokine therapies for the treatment of cancer and autoimmune diseases," said Dr. Nazli Azimi, Founder and CEO of Bioniz Therapeutics and co-inventor of BNZ-1. "We believe that the multi-cytokine targeting of BNZ-1 delivers a multimodal immunomodulation effect to decrease the proliferation of malignant cells, control the inflammation generated by the cancer in the tumor microenvironment, and lower the inhibitory activity of regulatory T-cells."

The Phase 1/2 clinical study was designed as a multi-center, open-label, dose-escalation study of BNZ-1 to assess its safety and efficacy as a single systemic agent in rCTCL patients that have failed standard of care and other available treatment options. The primary endpoint of the study was overall safety after four weeks of treatment. There was a three-month treatment extension to further evaluate safety and clinical response. Long Term Extension (LTE) was available for patients who benefited from BNZ-1 treatment. In the dose ranging part of the study, 15 patients (stages IB and IVB) were enrolled across the four dose cohorts (0.5, 1, 2, and 4 mg/kg) for intravenous weekly dosing. BNZ-1 showed activity in all doses as it was determined by early signs of clinical efficacy and pharmacodynamic (PD) biomarkers.

The 2 mg/kg dose was selected based on PK/PD relationship and clinical efficacy and expanded to a total of 19 patients. Clinical efficacy was measured by mSWAT and GRS as defined previously (Olsen E. et al. 2011). The results of the efficacy study of 19 patients are as follows:

• Based on the best response (GRS) one patient (5%) achieved a complete response, and eleven (58%) patients achieved a partial response by the end of the study (ORR 63.2%) that includes the LTE.
• Seven patients (37%) showed stable disease during study period. No disease recurrence was observed during the study period.

"Currently, rCTCL patients switch treatments every four months due to side effects, so we are extremely encouraged that BNZ-1 treatment was well tolerated, which could support long-term treatment for these patients," concluded Dr. Azimi.

About Refractory Cutaneous T-cell lymphoma (rCTCL)
Cutaneous T-cell lymphoma (CTCL) is a heterogeneous group of non-Hodgkin's lymphomas that manifest primarily in the skin. Although a wide array of therapeutic options are available for early-stage CTCL, not all patients respond, resulting in refractory CTCL (rCTCL) with limited treatment options and a poor prognosis.

About BNZ-1
The company's lead 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 CTCL. Bioniz is also evaluating BNZ-1 for the treatment of autoimmune diseases, including alopecia areata and vitiligo, which are also driven by unregulated T-cell biology.

About Bioniz Therapeutics
Bioniz Therapeutics is a clinical-stage biopharmaceutical company advancing a pipeline of first-in-class peptide-based multi-cytokine inhibitors for the treatment of cancer and autoimmune 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. For more information, please visit www.bioniz.com.

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SOURCE Bioniz Therapeutics, Inc.