A multi-cytokine inhibitor, BNZ-1, induced favorable clinical responses in patients with refractory cutaneous T-cell lymphoma (CTCL), according to findings from an interim analysis of a phase 1/2, multicenter, open-label clinical trial (NCT03239392), Bioniz Therapeutics, Inc, announced in a press release.
"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,” said Christiane Querfeld, MD, PhD, of the Cutaneous Lymphoma Program at the City of Hope, in a statement.
In the prior dose-escalation phase of the trial, favorable initial responses were observed in the 15 patients with refractory CTCL who were first enrolled in the 2 mg/kg cohort, and the cohort was then expanded to include 19 patients. Tumor burden was improved with BNZ-1 in 80% of patients per the modified severity weighted assessment (mSWAT) score without any accompanying treatment. Partial responses (PRs) were observed in 50% of patients per mSWAT, and complete responses (CRs) were seen in 5% of patients. Of the patients who achieved a PR or CR, the median duration of response was 9.2 months at the time of data cutoff.
"Together with our investigators, we are excited to see the potential clinical benefit of BNZ-1 in highly refractory CTCL patients," said Nazli Azimi, PharmD, PhD founder, president and chief executive officer of Bioniz Therapeutics, in a statement. "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".
The primary end point of the study is overall safety after 4 weeks of treatment with BNZ-1. The secondary end points are pharmacodynamics, single-doses, and steady-state maximum serum concentration, single-dose and steady-state area under the curve, and steady-state elimination of half-life. Disease severity, PRs and CRS are also being evaluated as exploratory end points. To further assess the activity and clinical response association with the agent, a 3-month treatment extension was implements. The study also allowed long-term extensions for patients who derived benefit from BNZ-1.
To be eligible for the study, patients are required to have histologically confirmed disease, anECOG performance status of 0 to 2, and a life expectancy of more than 1 year. Patients with a hepatic, neurological, pulmonary, ophthalmological, endocrine, renal, or other major systemic disease that is clinically relevant are excluded from the trial, along with individuals with known bacterial, viral, fungal, or mycobacterial infection.
The prospective completion of the phase 1/2 study is early Q3. The developer will then hold a phase 2 meeting in Q4 to discuss the start of the phase 3 clinical trial of BNZ-1 in refractory CTCL, for which the estimated start date is sometime in the first half of 2021.
BNZ-1, a leading product of Bioniz Therapeutics, Inc, is a selective and simultaneous inhibitor of the IL-2, IL-9, and IL-15 cytokines. In addition to being investigated as treatment of refractory CTCL, BNZ-1is being evaluated in patients with large granular lymphocyte leukemia.
Bioniz announces positive efficacy and safety data for BNZ-1 from interim analysis of phase 1/2 study in cutaneous T-cell lymphoma. News release. July 20, 2020. Accessed July 20, 2020. https://prn.to/3fPC3HA.