On March 28, 2025 Akeso reported the company and Transthera have entered into a strategic collaboration to jointly advance an open-label, multicenter Ph II clinical study to evaluate the combination of Akeso’s PD-1/CTLA-4 BsAb cadonilimab or PD-1/VEGF BsAb ivonescimab with Transthera’s innovative multi-target small-molecule kinase inhibitor tinengotinib (TT-00420) for the treatment of advanced HCC (Press release, Akeso Biopharma, MAR 28, 2025, View Source [SID1234654273]). The clinical protocol for this collaboration has recently received approval from China NMPA.
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Tinengotinib is an innovative, global Ph III stage spectrum-selective kinase inhibitor that exerts antitumor effects by targeting tumor cells and improving the tumor microenvironment. Ongoing clinical trials in the US and China have revealed the potential of Tinengotinib to be efficacious in various solid tumors. It was granted the Orphan Drug Designation and Fast Track Designation by US FDA for the treatment of CCA. In July 2023, tinengotinib was granted the Breakthrough Therapy Designation by China NMPA.
Cadonilimab is the world’s first approved bispecific immunotherapy for cancer. Previous studies have shown its significant efficacy and favorable safety profile in treating HCC. Data demonstrated that cadonilimab combined with FOLFOX-HAIC as neoadjuvant therapy for resectable multinodular HCC achieved a 100% DCR with manageable safety. Furthermore, cadonilimab combined with lenvatinib as a 1L treatment for advanced HCC showed superior antitumor activity compared to approved therapies, effectively controlling tumor progression and offering long-term survival benefits over current treatment options.
Ivonescimab is a novel global first-in-class PD-1/VEGF bispecific immunotherapy. Ivonescimab was granted marketing approval by China NMPA for the treatment of EGFR mutated locally advanced or metastatic nsNSCLC patients who have progressed after EGFR TKI treatment. Currently, ivonescimab’s first indication has been approved in China, and Akeso is conducting 6 registrational trials versus anti-PD-1/L1 therapeutics. Akeso is also conducting multiple clinical trials of ivonescimab covering 17 indications including GC, HCC and CRC.