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December 30, 2021

Bio-Thera Solutions begins dosing in Phase I trial of cancer drug

A monoclonal antibody targeting TIGIT in cancer patients, BAT6005 was discovered using the company’s IDEAL platform.

By Shalini Nair

China-based commercial stage pharmaceutical firm Bio-Thera Solutions has commenced dosing in the Phase I clinical trial of BAT6005, a monoclonal antibody to target TIGIT in cancer patients.

The trial will evaluate the pharmacokinetics and safety of BAT6005, which was discovered using the firm’s fully synthetic human antibody discovery platform, called IDEAL, which stands for Intelligent Design and Engineered Antibody Libraries.

BAT6005 has normal IgG1 ADCC function.

Bio-Thera Solutions SVP Dr. Jin-Chen Yu said: “TIGIT is an immune-oncology drug target of significant interest. Preclinical data generated in support of the BAT6005 IND is very promising.

“BAT6005 is one of several IO assets that are entering Phase 1 studies and transition Bio-Thera’s innovative IO pipeline from primarily a preclinical pipeline to a clinical pipeline. We plan to explore combinations of BAT6005 with BAT1308, our novel PD-1 antibody, to treat a broad range of cancers.”

The multicentre, open-label, dose-escalation Phase I trial to evaluate the safety and tolerability aspects of BAT6005 as a single agent.

This trial expects to enrol patients suffering with advanced solid tumour.

The primary aim of the trial includes ascertaining maximum tolerated dose, preliminary anti-tumour activity, and pharmacokinetics.

Bio-Thera Solutions stated that it plans to enrol disease-specific expansion groups at the biologically relevant or maximally tolerated dose.

Based in Guangzhou of China, Bio-Thera Solutions develops drugs for the treatment of cancer, autoimmune, cardiovascular diseases, and other serious unmet medical needs, as well as biosimilars for existing, branded biologics for the treatment of a range of cancer and autoimmune diseases.

It has advanced six drug candidates into late-stage clinical trials and two candidates, QLETLI and POBEVCY are available for treatment in the country.

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