Biopharmaceutical company Innovent Biologics Inc (HKEX:01801) revealed on Wednesday that it has dosed the first patient with with advanced solid tumor in a Phase I clinical trial of IBI101, a recombinant fully human anti-tumor necrosis factor receptor superfamily member 4 (anti-OX40) monoclonal antibody.
Under the Phase I clinical study, the tolerance, safety and primary efficacy of the company's IBI101, either as monotherapy or in combination with Tyvyt (sintilimab injection), an anti-programmed cell death protein 1 (PD-1) antibody, will be evaluated.
The company added that the Phase I clinical trial comprises two parts: a Phase Ia study with IBI101 as monotherapy and a Phase Ib study with IBI101 in combination with Tyvyt. The patients with advanced solid tumors who have failed standard treatments will be enrolled in the study.
According to the company, the IBI101 is a recombinant fully human anti-OX40 monoclonal antibody with independent intellectual property rights. It has a clear mechanism of action that enhances the activation of effector T cells and mediates the clearance of regulatory T cells, thus inhibiting the growth of tumor cells. The IND application of IBI101 was approved by the US FDA in 2018.
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