Bio-Thera Solutions, a clinical-stage pharmaceutical company, today announced that patient dosing has begun in a Phase I clinical study of BAT4306F in relapsed/refractory CD20-positive B-cell non-Hodgkin's lymphoma patients. BAT4306F is an ADCC-enhanced CD20 monoclonal antibody that has demonstrated enhanced potency in preclinical studies with potential to be a “best-in-class” therapeutic.
“Initiating our Phase I clinical trial for BAT4306F represents a major milestone for Bio-Thera Solutions as BAT4306F is our first clinical candidate developed for the treatment of hematologic malignancies,” said Shengfeng Li, CEO, Bio-Thera Solutions. “While the BAT4306F development plan will be initially focused on CD20-positive B-cell non-Hodgkin's lymphoma we believe BAT4306F also has great potential as a treatment for other hematologic malignancies.”
The Phase 1, multicenter, open-label, dose-escalation clinical trial of BAT4306F is designed to assess the safety and tolerability of BAT4306F as a single agent. The study will enroll subjects with relapsed/refractory CD20-positive B-cell non-Hodgkin's lymphoma. Key objectives in the study include determining maximum tolerated dose, dose-limiting toxicity, pharmacokinetics and recommended doses for phase II clinical studies.
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