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May 10, 2022

Bio-Thera doses first subject in Phase I solid tumour antibody trial

In a non-human primates study, BAT7104 was found to be well tolerated without any adverse effects.

Bio-Thera Solutions has dosed the first subject in the Phase I clinical trial of bispecific antibody, BAT7104, to treat advanced solid tumours in Australia.

BAT7104 hinders the interaction of human PD-L1 and CD47 with their respective receptors.

The multicentre, open-label, dose-escalation trial will analyse the safety and tolerability of BAT7104 to treat advanced solid tumours.

Determining the maximum tolerated dose and recommended Phase II dose (RP2D) of BAT7104 and assessing the pharmacokinetics and initial efficacy of the antibody in advanced solid tumour patients are the main goals of the trial.

BAT7104 demonstrated to hinder PD-1/PD-L1 and CD47/SIRP-α pathways in vitro and showed synergistic activity in eliciting total tumour regression in vivo. 

Bio-Thera Solutions CEO Dr Shengfeng Li said: “BAT7104 has demonstrated higher anti-tumour activity with better safety profile in preclinical studies.”

“As the first bispecific antibody of Bio-Thera, we are pleased to see BAT7104 enter clinical development in Australia, and we will continue bringing more innovative anti-tumour drugs to cancer patients.”

Apart from the trial in Australia, the company is carrying out a Phase I trial of BAT7104 in China enrolling solid tumour and lymphoma patients. 

Bio-Thera focuses on the development of new therapies to treat cancer, autoimmune, cardiovascular ailments and other serious unmet medical needs.

The company is also developing various new oncology assets in early-stage trials, which are directed at key IO targets, including OX40, CTLA-4, PD-1 and TIGIT.

In March this year, Bio-Thera dosed the first subject in Phase I trial of BAT6026 plus BAT1308 for the treatment of advanced solid tumour patients in Australia.

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