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December 10, 2018

Bio-Thera Solutions starts dosing in Phase I BAT4306F trial

Bio-Thera Solutions has started dosing patients in a Phase I clinical trial of BAT4306F to treat relapsed/refractory CD20-positive B-cell non-Hodgkin’s lymphoma.

Bio-Thera Solutions has started dosing patients in a Phase I clinical trial of BAT4306F to treat relapsed / refractory CD20-positive B-cell non-Hodgkin’s lymphoma.

The Chinese company will evaluate the safety and tolerability of BAT4306F as a single agent as part of the multicentre, open-label, dose-escalation trial.

The trial is expected to enrol patients with relapsed / refractory CD20-positive B-cell non-Hodgkin’s lymphoma.

Key objectives of the trial comprise identifying maximum tolerated dose, dose-limiting toxicity, pharmacokinetics and recommended doses for subsequent Phase II clinical studies.

“We believe BAT4306F also has great potential as a treatment for other hematologic malignancies.”

Bio-Thera Solutions CEO Shengfeng Li said: “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.

“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.”

BAT4306F is an antibody-dependent cell-mediated cytotoxicity (ADCC) enhanced CD20 monoclonal antibody. It has shown improved potential in preclinical studies.

The drug is also a naturally occurring receptor found to be overexpressed in various types of hematologic malignancies.

The solution is currently under development for use as a single agent and in combination with other agents for multiple hematologic malignancies including relapsed / refractory CD20-positive B-cell non-Hodgkin’s lymphoma.

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