On August 25, 2023 Akeso Inc. ("Akeso", the "Company"; 9926.HK), a commercial-stage biopharmaceutical company focused on developing and commercializing first-in-class and best-in-class innovative medicines globally, reported that the National Center for Drug Evaluation of the State Drug Administration of the People’s Republic of China (NMPA CDE) has granted priority review of New Drug Application (NDA) for ivonescimab, a potential first-in-class investigational PD-1/VEGF bi-specific antibody (Press release, Akeso Biopharma, AUG 25, 2023, View Source [SID1234634699]).
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In December 2022, Akeso entered into a collaboration and license agreement for up to US$5 billion with Summit Therapeutics("Summit"). Akeso out-licensed to Summit exclusive rights to ivonescimab (PD-1/VEGF) for the development and commercialization in the United States, Canada, Europe, and Japan. Akeso will retain development and commercialization rights for the rest of the world including China. Ivonescimab is known as AK112 for Akeso’ R&D code at China and Australia, and as SMT112 for Summit’s license territories.
Previously, CDE has granted Breakthrough Therapy Designation (BTD) for ivonescimab for three lung cancer indications. On August 1, 2023, the first NDA for ivonescimab was accepted by the CDE. The Priority Review process for ivonescimab is a milestone for the clinical value recognition of ivonescimab, which will expedite the process of approval and marketing of ivonescimab.
Ivonescimab is Akeso’s other novel bispecific antibody with a priority review following the marketing approval of cadonilimab (PD-1/CTLA-4 bispecific antibody). Prior to this, the review process for cadonilimab under Priority Review took only 9 months to complete, making it the world’s first approved bispecific antibody drug for cancer immunotherapy.
Following an acceptance of marketing application of ivonescimab by the China CDE, four pivotal registrational Phase III clinical trials have been initiated/are being conducted worldwide, including three head-to-head trials with PD-1 monoclonal antibody as the positive control drug:
A Phase III study of ivonescimab monotherapy versus pembrolizumab monotherapy as first-line treatment for NSCLC patients with positive PD-L1 expression (AK112-303), which has been granted BTD in China.
An international multicenter Phase III study of Ivonescimab in combination with chemotherapy for patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC progressing on third-generation EGFR-TKI therapy (HARMONi/AK112-301), which has been granted BTD in China.
A Phase III study in China for the first-line treatment of advanced squamous NSCLC with ivonescimab in combination with chemotherapy versus tislelizumab in combination with chemotherapy（AK112-306).
An international multicenter Phase III study of ivonescimab in combination with chemotherapy versus pembrolizumab monoclonal antibody in combination with chemotherapy as the first-line treatment for metastatic squamous NSCLC (HARMONi-3).
About Ivonescimab
Ivonescimab is a potential first-in-class investigational PD-1/VEGF bi-specific antibody discovered by Akeso and is believed to be the PD-1 / VEGF bispecific antibody that is most advanced in the clinic. It combines the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab is currently engaged in multiple Phase III clinical trials worldwide.