On October 21, 2021 Akeso, one of leading Chinese pharmaceutical innovation company reported that the first patient was dosed in a phase I clinical trial of the Company’s independently developed TIGIT monoclonal antibody (AK127) in combination with the Company’s global first-in-class Cadonilimab (PD-1/CTLA-4 bi-specific antibody,AK104) for the treatment of advanced or metastatic solid tumors in Australia (Press release, Akeso Biopharma, OCT 21, 2021, View Source [SID1234591731]).
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This is an open-label, multicenter phase I clinical trial designed to evaluate the safety, tolerability, pharmacokinetic, immunogenicity, pharmacodynamics and anti-tumor activity of AK127 in combination with Cadonilimab in subjects with advanced or metastatic solid tumors.
Clinical trials have demonstrated promising efficacy of TIGIT monoclonal antibody in combination with PD-1 monoclonal antibody in immuno-oncology therapy. Cadonilimab simultaneously targets the two well-established immune checkpoints, PD-1 and CTLA-4. Preclinical studies showed that the combination of AK127 and Cadonilimab produced a significantly enhanced anti-tumor effect in mice model.
Based on the promising efficacy seen in both preclinical and clinical studies on TIGIT monoclonal antibody in combination with PD-1 monoclonal antibody therapy, AK127 in combination with Cadonilimab has the potential to demonstrate significant anti-tumor activity in treating patients with solid tumors, further enhance the potential and outlook of combination therapy, and strengthen and enrich the Company’s multi-target portfolio in immuno-oncology therapy.
By developing a rich pipeline of therapeutic antibodies for the treatment of cancer, the Company seeks to transform the treatment paradigm in the immuno-oncology space with combination therapies against various immune targets; and realise the full commercial value of its bi-specific antibodies that are based on a PD-1 antibody backbone. Currently, clinical trials such as Cadonilimab in combination with CD47 monoclonal antibody ( AK117), VEGFR-2 monoclonal antibody (AK109), CD73 monoclonal antibody (AK119) and PD-1/VEGF (AK112) in combination with AK117, have all been successfully initiated.