Akeso receives China NMPA approval to begin phase Ib/II trial of Ivonescimab in combo with drebuxelimab to treat advanced solid tumours

Akeso, Inc., a China-based biopharmaceutical company, announced that the phase Ib/II clinical trial of its in-house developed Ivonescimab (PD-1/VEGF bi-specific, AK112) combined with its drebuxelimab (CD73, AK119) for the treatment of advanced solid tumours, has been approved by the National Medical Products Administration (NMPA). AK112 is the first PD-1/VEGF bi-specific antibody that entered phase III clinical research. The PD-1 antibody and VEGF blocker combination therapy has shown strong efficacy in various tumour types. AK119 targets the key node of CD73 through the adenosine pathway, and its inhibitor has broad therapeutic prospects for tumours that are quite sensitive to the adenosine pathway. Combination with immune checkpoint drugs such as AK112 can strengthen the synergistic effect of tumour therapy. AK119 combined with AK112 has demonstrated well in vivo pharmacodynamic activity and safety in relevant pre-clinical studies. This unique combination therapy strategy will bring breakthroughs in tumour therapy. Ivonescimab is a first-in-class and the first to enter phase III clinical trial PD-1/VEGF bi-specific antibody independently developed by the Company. Engineered with our unique Tetrabody technology, Ivonescimab blocks PD-1 binding to PD-L1 and PD-L2, and blocks VEGF binding to VEGF receptors. PD-1 antibodies combined with VEGF-blocking agents have shown robust efficacy in various tumour types (including renal cell carcinoma, non-small cell lung cancer, and hepatocellular carcinoma). Given the co-expression of VEGF and PD-1 in the tumour microenvironment, Ivonescimab, as a single agent to block these two targets, may block these two pathways more effectively and enhance the antitumor activity, as compared to combination therapy. Currently, Akeso is conducting a phase III clinical trial of AK112 monotherapy versus Pembrolizumab monotherapy as the first-line treatment for NSCLC patients with positive PD-L1 expression. In addition, a phase III clinical trial of AK112 plus chemotherapy versus chemotherapy in EGFR mutated advanced non-squamous NSCLC that failed in prior EGFR-TKI therapy is ongoing. AK112 has started multiple clinical trials for various stages of treatment of indications, including non-small cell lung cancer and small cell lung cancer. Drebuxelimab is a humanized monoclonal antibody self-developed by the Company with a unique mechanism to activate B-cells to generate immune responses to tumour antigens and viruses. It can significantly inhibit the enzymatic activity of CD73 and block the production of immunosuppressive adenosine. No similar product has been successfully developed and commercialized in the global market.

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