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CStone Pharmaceuticals has dosed the first subject in the multicentre Phase I trial of its trispecific antibody, CS2009.
Designed and developed by the company, the antibody combines three targets, programmed cell death protein 1 (PD-1), vascular endothelial growth factor A (VEGFA), and cytotoxic T-lymphocyte–associated antigen 4 (CTLA-4), which are clinically validated.
It applies multidimensional anti-tumour effects by reversing T cell exhaustion, promoting activation and proliferation of T cell, and blocking tumour angiogenesis, which could enhance the tumour microenvironment.
The trispecific antibody has shown promising results in preclinical studies, demonstrating 'superior' anti-tumour activity against existing treatments.
CS2009's mechanism of action, which includes preferentially targeting double-positive tumour-infiltrating T cells, could provide improved 'efficacy' with 'lower' systemic toxicity.
The trial will explore CS2009 in treating various types of advanced solid tumours, including non-small cell lung cancer, ovarian cancer, and hepatocellular carcinoma, among others.
The Phase I trial is currently underway in Australia, with plans to extend into the US and China.
CStone R&D president, CEO and executive director Dr Jason Yang said: “The initiation of the first-in-human study for CS2009 marks a breakthrough in our clinical development.
“In in vitro studies, CS2009 demonstrated its ability to effectively and specifically activate tumour-infiltrating T cells, as well as robust synergistic effect with anti-VEGF activity; in immunocompetent mouse models, CS2009 showed stronger anti-tumour effects than both PD-1/CTLA-4 and PD-1/VEGF bispecific antibodies; and in toxicology studies, CS2009 exhibited a safety margin which was greater than the PD-1/CTLA-4 bispecific antibody and comparable to the PD-1/VEGF bispecific antibody.”
To date, the company has launched four drugs and obtained clearances for 16 new applications covering nine indications.
"CStone doses first subject in trial of CS2009 for advanced solid tumours" was originally created and published by Clinical Trials Arena, a GlobalData owned brand.
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