On July 20, 2020 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 cancers, reported encouraging interim clinical data from its Phase 1/2 open-label clinical study of its lead product candidate BNZ-1 in patients with refractory Cutaneous T-Cell Lymphoma (rCTCL) (Press release, Bioniz Therapeutics, JUL 20, 2020, View Source [SID1234562144]). 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, dose proportionality and exposure-dependent pharmacodynamic activity .
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This study followed a phase 1/2, multi-center, open-label, dose-escalation clinical study of BNZ-1 and was designed to assess its safety and activity as a single systemic agent in rCTCL patients that have failed standard of care and other available treatment options. The study was designed to recruit a total of 15 patients across 4 doses of 0.5, 1, 2, and 4 mg/kg for intravenous weekly dosing. The primary endpoint was overall safety after 4 weeks of treatment. There was a 3-month treatment extension to further evaluate safety and clinical response. Long term extension was available for patients who benefited from BNZ-1 treatment.
Whereas efficacy was observed in all cohorts, the 2 mg/kg cohort was expanded to 19 patients based on a favorable initial clinical response. Overall, BNZ-1 was well tolerated with no dose-limiting toxicities. On average, these rCTCL patients had failed 7 prior skin-directed and systemic therapies. The 2 mg/kg cohort showed signs of clinical improvement with BNZ-1 treatment, as follows:
Over 80% of subjects showed some improvement in tumor burden as assessed by the modified severity weighted assessment tool (mSWAT) score in the absence of any concomitant therapy
About half achieved a partial response (at least a 50% reduction from baseline) in mSWAT score
5% of subjects achieved a complete response
For subjects achieving a partial or complete response, the mean duration of response was 277 days (9.2 months) at the time of the data cut off for this interim analysis
Dr. Christiane Querfeld, Director of the Cutaneous Lymphoma Program at the City of Hope, who was the principal investigator of this study, stated "I am pleased with the interim results of the BNZ-1 trial in a highly refractory patient population. Based on this interim analysis, BNZ-1 appears to be safe and well tolerated in CTCL patients. In this trial, BNZ-1 has shown efficacy in heavily pretreated and/or advanced stage patients who have failed standard of care and investigational drugs available to them. As a physician, I look forward to the continued development of BNZ-1 and hope to eventually have this drug in my practice to treat and manage my CTCL patients."
"Together with our investigators, we are excited to see the potential clinical benefit of BNZ-1 in highly refractory CTCL patients," said Dr. Nazli Azimi, Founder, President and Chief Executive Officer of Bioniz Therapeutics. "We are eager to further advance the clinical development of BNZ-1 towards approval in CTCL and to evaluate its potential clinical efficacy in other dermatological diseases such as alopecia areata and vitiligo." She added "these data provide additional validation of our platform technology and our approach for multi-cytokine inhibition".
Bioniz expects this study to conclude in early Q3 of this year and will submit a request for an end of phase 2 meeting in Q4. Based on the outcome of this meeting, Bioniz anticipates starting phase 3 in 1H 2021.
About T-Cell Leukemia and Lymphoma
T-cell leukemia and lymphoma include a group of rare and often aggressive diseases, including CTCL with 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 this T-cell malignancy.
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. BNZ-1 is currently under investigation in a phase 1/2 clinical trial for refractory Cutaneous T-Cell Lymphoma (rCTCL) and Large Granular Lymphocyte (LGL) Leukemia (www.clinicaltrials.gov identifier: NCT03239392).