Cadonilimab

HONG KONG, Nov. 27, 2024 /PRNewswire/ -- Akeso, Inc. (9926. HK) ("Akeso" or the "Company") is pleased to announce that two of its independently developed, globally pioneering bispecific antibody drugs—cadonilimab Injection (PD-1/CTLA-4 bispecific antibody) and ivonescimab Injection (PD-1/VEGF bispecific antibody)—have both been included in the most recent National Reimbursement Drug List (NRDL) released by China's National Healthcare Security Administration. The most recent NRDL will become effective on January 1, 2025. Cadonilimab is included for the treatment of relapsed or metastatic cervical cancer (R/M CC) patients who progressed on or after platinum-based chemotherapy. Ivonescimab is included for the treatment of epidermal growth factor receptor (EGFR) mutated locally advanced or metastatic non-squamous non-small cell lung cancer (nsq-NSCLC). China's medical insurance system includes basic medical insurance, work-related injury insurance, and maternity insurance, covering over 95% of the population. The NRDL defines the medications eligible for reimbursement under the medical insurance fund. According to statistical reports, in 2023, expenditures from China's basic medical insurance, work-related injury insurance, and maternity insurance funds on drugs listed in the NRDL accounted for 90% of total hospital procurement orders. Dr. Xia Yu, the Founder, Chairwoman, President, and Chief Executive Officer of Akeso, said, " The inclusion of cadonilimab and ivonescimab in the National Reimbursement Drug List emphasizes the innovative and clinical significance of these groundbreaking biologics, both of which are developed by Akeso. The inclusion marks a significant milestone in improving patient access to innovative treatments. It will substantially reduce the financial burden on patients, allowing more individuals to benefit from globally leading therapies. This development aligns perfectly with Akeso's core philosophy of advancing public health through scientific and technological innovation." Cadonilimab: Global First Approved Cancer Immunotherapy Bispecific Antibody Cadonilimab is an innovative bispecific antibody that simultaneously targets PD-1 and CTLA-4, leveraging a synergistic antitumor effect. This unique mechanism significantly enhances therapeutic outcomes, offering superior efficacy while greatly reducing toxicity. The latest data on cadonilimab for R/M CC shows that cadonilimab benefits both PD-L1 positive and negative patient populations, especially addressing an unmet need from PD-L1 negative patients, which previously lacked effective treatment options. For R/M CC, cadonilimab demonstrated a median overall survival (mOS) of over 18 months (NR), with an objective response rate (ORR) of 31.3% and a complete response (CR) rate of 13.1% in In the PD-L1 positive subgroup, the ORR reached 43.8%, with a median progression-free survival (mPFS) of 6.34 months, and the mOS is yet to be reached. On September 2024, cadonilimab was approved by NMPA for first-line treatment of advanced gastric cancer. The sNDA for first-line treatment of advanced cervical cancer is under review. Cadonilimab has been strongly recommended in 16 clinical treatment guidelines and consensus statements, covering a variety of cancers, including gastric cancer, gynecological cancers, liver cancer, esophageal cancer, and nasopharyngeal cancer. Furthermore, cadonilimab is currently undergoing more than 23 clinical trials across 16 indications, including gastric, lung, liver, cervical, and pancreatic cancers. Among these trials, 8 are registration Phase III trials. Ivonescimab: Global First Approved PD-1/VEGF Bispecific Antibody Ivonescimab is the world's first bispecific antibody that integrates "cancer immunotherapy and anti-angiogenesis" into a synergistic mechanism. In the Phase III HARMONi-A trial, for 2L+ EGFRm NSCL, ivonescimab combination therapy reduced the risk of disease progression or death by a record 54%, with a significant trend towards long-term survival benefits. Additionally, the Phase III HARMONi-2 trial comparing ivonescimab monotherapy with pembrolizumab in first-line treatment of PD-L1-positive non-small cell lung cancer (NSCLC) showed ivonescimab's superiority. Ivonescimab is the only drug globally to have demonstrated significantly better efficacy than pembrolizumab in a Phase III head-to-head trial. The sNDA for Ivonescimab in the first-line treatment of PD-L1-positive NSCLC is currently under regulatory review, with priority review status granted. Ivonescimab has already been robustly recommended within six major clinical treatment guidelines and consensus statements. Additionally, ivonescimab has been engaged in over 25 clinical trials spanning more than 17 varieties of cancers, namely lung cancer, head and neck squamous cell carcinoma, biliary tract cancer, pancreatic cancer, breast cancer, hepatocellular carcinoma, and colorectal cancer. Nearly 10 Phase III trials of ivonescimab are progressing efficiently in China and the rest of the World, with one of them being on head and neck squamous cell carcinoma. About Akeso Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique 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 core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 22 candidates have entered clinical trials (including 11 bispecific/multispecific antibodies and bispecific antibody-drug conjugates). Additionally, 5 new drugs are commercially available, and 5 new drugs across 7 indications are currently under regulatory review for approval. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise. For more information, please visit and follow us on Linkedin, and X (formerly Twitter). SOURCE Akeso, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

HONG KONG, Nov. 7, 2024 /PRNewswire/ -- At the 2024 Annual Meeting of the Society for Immunotherapy of Cancer (SITC 2024), held in Houston, USA, from November 6 - 10, Akeso Biopharma (9926. HK) presented the mechanism of action (MOA) research findings of its innovative bispecific antibody, AK132, targeting both Claudin18.2 (CLDN18.2) and CD47. AK132 is an asymmetric bispecific antibody with a "1+1" valency, designed to simultaneously target and block CLDN18.2 and CD47. It features a wild-type IgG1 Fc structure and is currently in the clinical research stage. CD47 is overexpressed on a variety of cancer cells, where it interacts with its ligand SIRPα on innate immune cells to inhibit tumor phagocytosis. Claudin 18.2 (CLDN18.2), a tight junction protein, is abnormally activated and overexpressed in several primary malignancies. It has been recognized as a key tumor antigen target in gastric and pancreatic cancers. Studies have demonstrated that AK132 binds with high affinity to both human CLDN18.2 and human CD47. On one hand, it competitively blocks the interaction between CD47 and its ligand SIRPα, thereby disrupting the CD47-SIRPα axis and relieving the inhibition of tumor cell phagocytosis. This enables macrophage-mediated phagocytosis of CLDN18.2+/CD47+ tumor cells, thereby enhancing the antitumor activity of immune cells. On the other hand, AK132 also induces potent tumor cell killing through Fc-mediated effector functions, such as ADCC, ADCP, and CDC, leading to superior antitumor efficacy compared to anti-CLDN18.2 monoclonal antibodies. In subcutaneous tumor xenograft models in mice, AK132 demonstrated significantly stronger antitumor activity than anti-CLDN18.2 monoclonal antibodies. Ak132 Efficiently Binds to CLDN18.2 and CD47, Exerting Antitumor Effects through Multiple Mechanisms Research shows that AK132 binds with high affinity and specificity to human CLDN18.2 and human CD47, competitively blocking the interaction between CD47 and its ligand SIRPα. This disruption of the CD47-SIRPα interaction releases the inhibition on tumor cell phagocytosis, enhancing immune cell anti-tumor functions. AK132 mediates macrophage phagocytosis of CLDN18.2+/CD47+ tumor cells and effectively inhibits tumor growth in subcutaneous xenograft mouse models. AK132 also efficiently kills tumor cells through Fc-mediated effector functions, such as ADCC (antibody-dependent cell-mediated cytotoxicity), ADCP (antibody-dependent cellular phagocytosis), and CDC (complement-dependent cytotoxicity). AK132 Shows no RBC Toxicity, Does not Bind to Red Blood Cells or Induce Agglutination, Demonstrating Good Safety Profiles Although CD47 is considered a promising target for cancer immunotherapy, the therapeutic efficacy of CD47 monoclonal antibodies is significantly limited by their considerable toxicity to red blood cells. AK132 features a unique structural design that reduces its affinity for CD47. In vitro studies have shown that AK132 binds minimally to human red blood cells, does not induce ADCP or ADCC activity against red blood cells (thus preventing red blood cell killing), and does not cause red blood cell aggregation, demonstrating an absence of erythrocyte toxicity. Six Globally Leading Bispecific Antibodies Efficiently Propel Cancer Immunotherapy into the 2.0 Era Akeso's investigational New Drug application (IND) application for AK132, aimed at treating advanced malignant solid tumors, has been approved by the China NMPA. Akeso has strategically built a leading, target-rich pipeline of bispecific antibodies, establishing a competitive edge in cancer immunotherapy. Among these, cadonilimab (PD-1/CTLA-4 bispecific) and ivonescimab (PD-1/VEGF bispecific) are already market-approved. Four other bispecific antibodies, including AK129 (PD-1/LAG-3), AK130 (TIGIT/TGF-β fusion protein), AK131 (PD-1/CD73), and AK132 (CLDN18.2/CD47), are currently in clinical trials. ### About AK132 （ Claudin18.2/CD4 bispecific antibody ） AK132 is a bispecific antibody developed by Akeso, targeting the recombinant humanized Claudin18.2 (CLDN18.2) splice variant 2 and CD47 for the treatment of various cancers, including gastric, esophageal, pancreatic, ovarian, and lung adenocarcinomas. AK132 binds with high affinity to both human CLDN18.2 and CD47, effectively blocking the interaction between CD47 and its ligand SIRPα. In mouse subcutaneous tumor models, it significantly inhibits tumor growth. AK132 shows no ADCC or ADCP activity in human RBC-targeted assays and does not cause RBC aggregation. As a bispecific antibody, it holds potential as a cancer therapy with both efficacy and safety. About Akeso Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique 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 core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions.With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 22 candidates have entered clinical trials (including 11 bispecific/multispecific antibodies and bispecific antibody-drug conjugates). Additionally, 5 new drugs are commercially available, and 5 new drugs across 7 indications are currently under regulatory review for approval. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise. SOURCE Akeso, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED