Clinical Trials

ZielBio to Present Interim Findings from its Phase 1/2

ZB131 is a first-in-class humanized monoclonal antibody targeting cancer-specific plectin (CSP), which is expressed on the surface of cancer cells in solid tumors

Interim data demonstrates safety and tolerability of ZB131 while providing evidence of clinical activity in a proportion of patients with difficult-to-treat tumors

ZielBio, Inc., a clinical stage biotechnology company discovering new treatments for cancer and other serious diseases, will present the first set of clinical data from its lead asset, ZB131, directed against cancer-specific plectin (CSP), during the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. In an interim analysis (n=32) of the Phase 1/2 trial, ZB131 demonstrated a favorable safety and tolerability profile, evidence of clinical activity and dose-proportional pharmacokinetics.

Dr. David Sommerhalder, principal investigator at NEXT Oncology in San Antonio, Texas, will present the data in a poster session (board 281) on Saturday, June 3 from 9:00 am to 12:30 pm in poster Hall A at Chicago’s McCormick Place.

The ZB131 clinical trial (trial identifier NCT05074472) is a Phase 1/2, first-in-human, open-label, dose escalation study of ZB131 in tumors likely to express CSP. The primary objective of the dose escalation phase was to evaluate the safety and tolerability of ZB131 as a monotherapy. Having established safe dosing levels, the study began enrolling expansion cohorts treating patients with either ZB131 at 30 mg/kg as a monotherapy or ZB131 at 15 mg/kg in combination with gemcitabine.

“The initial safety, pharmacokinetics and clinical activity from the Phase 1/2 trial, combined with preclinical evidence that ZB131 binds selectively to CSP, rapidly internalizes, and can be conjugated to cytotoxic payloads, validates our efforts to further develop ZB131, including as an antibody-drug conjugate (ADC),” said Alan Bash, CEO of ZielBio. “CSP is a highly promising target given its cell surface expression in malignant tissue and lack of presence in healthy tissue across multiple solid tumors, and ZielBio is leading the field of research into this target.”

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