CStone Pharmaceuticals has enrolled and dosed the first patient in a Phase I clinical trial to evaluate CS1003 for the treatment of advanced cancers.
The multi-centre trial is being led by Beijing Cancer Hospital in China and aims to investigate the safety, tolerability and preliminary anti-tumour activity of CS1003 in patients.
CStone Pharmaceuticals chairman and CEO Dr Frank Jiang said: “CS1003 is an important IO backbone in CStone's pipeline and, together with our PD-L1 monoclonal antibody (CS1001), is essential to our combination therapy strategy.
“We are happy to see the Phase I trial get under way in China.
“We plan to carry out global development for this promising drug candidate as monotherapy and in combination with internal and external therapies to benefit cancer patients in China and globally.”
Programmed death-1 (PD-1) is an inhibitory checkpoint receptor expressed on T cells.
In normal circumstances, PD-1 binds with its ligands, programmed death ligand-1 or ligand 2 (PD-L1/PD-L2) to inhibit T cell and cytokine activation and to enable dampening of the immune response in order to stop damage to healthy tissues.
CStone Pharmaceuticals chief medical officer Dr Jason Yang said: “CS1003 is a humanised, IgG4 monoclonal antibody that has already generated strong preclinical data, with the unique advantage of recognising both human and murine PD-1.
“A Phase I trial for the drug candidate is currently ongoing in Australia, while investigational new drug (IND) approval was received in the US in recent weeks.”
The trial intends to recruit a total of 60 adult patients and is expected to be completed by April 2020.