HONG KONG, China I August 18, 2023 I Akeso Inc. (“Akeso”, 9926. HK) announced today that the first patient has been dosed in a head-to-head phase III trial of ivonescimab, a potential first-in-class investigational PD-1/VEGF bi-specific antibody discovered by Akeso. The Phase III trial will evaluate the clinical efficacy and assess the safety of ivonescimab compared with tislelizumab in combination with chemotherapy as first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer (sq-NSCLC).

The international multicenter Phase III clinical trial of ivonescimab for this specific indication is currently ongoing. According to the latest clinical development plan for ivonescimab released by Summit Therapeutics, a partner of Akeso in the global development of ivonescimab, the international multicenter Phase III clinical study of ivonescimab in combination with chemotherapy versus pembrolizumab in combination with chemotherapy for first-line treatment of metastatic sq-NSCLC (HARMONi-3 ) is scheduled to dose the first patient in the second half of 2023.

The use of PD- (L)1 inhibitors in conjunction with chemotherapy is the current standard of care (SOC) for lung cancer worldwide, especially in the United States and China. However, despite this approach, there is still significant room for improvement in terms of prognosis, as there remains an extensive unmet need.

Currently, ivonescimab has been engaged in several Phase III head-to-head trials compared with standard of care PD-(L)1 inhibitors for lung cancer in developed countries worldwide, including China, the United States, Europe, and other developed countries. Akeso and Summit are determined and confident in pursuing stronger evidence-based medical research for ivonescimab, with a specific emphasis on the drug’s clinical value. These efforts aim to expedite the drug’s time to market and ensure its commercial success on a global scale.

Following an acceptance of marketing application for an indication 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 chemotherapyAK112-306).
  • 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. Ivonescimab is currently developed by Akeso (known as AK112) in China and Australia and Summit (known as SMT112) in the United States, Canada, Europe, and Japan (Summit’s license territories). 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.

About Akeso Inc.

Akeso (HKEX: 09926) is a commercial-stage biopharmaceutical company committed to discovering, developing, manufacturing, and commercializing innovative medicines that address significant medical needs globally. Since our inception, we have established a distinctive and integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the fundamental components, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode.

Akeso is internally working on a robust pipeline of over 30 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease, and other major therapeutic areas. 19 assets have entered clinical stage and 3 innovative drugs has been approved. Leveraging in-house developed bispecific platform technology (“Tetrabody technology”), the company has advanced four potential first-in-class bispecific antibody drugs into market or clinical development, including cadonilimab (PD-1/CTLA-4), ivonescimab (PD-1/VEGF), PD-1/LAG-3, and TIGIT/TGF-Beta bispecific antibodies. In June 2022, cadonilimab was approved by the NMPA and became the first commercialized PD-1 based bispecific drug globally. Another Akeso internally discovered and developed oncology product, penpulimab (a PD-1 antibody), was granted marketing approval in China in August 2021. In December 2022, Akeso granted exclusive development licensing rights to Summit Therapeutics in the United States, Canada, Europe and Japan for ivonescimab, a breakthrough PD-1/VEGF bispecific antibody independently developed by Akeso. Akeso has received an upfront payment equivalent to US$500 million and the total potential deal value is up to US$5 billion, including regulatory and commercial milestone payments. Akeso will also receive a low double-digit percentage of royalties on net product sales. Akeso is listed on the Main Board of the Stock Exchange of Hong Kong Limited.