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.
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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.
