Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 12 |
| INN | Cadonilimab |
| Status | Approved |
| Drug code(s) | AK104 |
| Brand name | 开坦尼® |
| mAb sequence source | mAb humanized |
| General Molecular Category | Bispecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | PD-1, CTLA-4 |
| Indications of clinical studies | Pancreatic cancer, Clear Cell Renal Cell Carcinoma, Non-small cell lung cancer, MSI-H/dMMR Solid Tumor, Cervical cancer, Hepatocellular carcinoma, peripheral T-cell lymphoma, Melanoma, Gastric or Gastroesophageal Junction Adenocarcinoma, Solid tumors |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved China |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | October 03, 2017 |
| Start of Phase 2 | January 13, 2019 |
| Start of Phase 3 | |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | 2022 |
| Date of first US approval | |
| INN, US product name | Cadonilimab |
| US or EU approved indications | None |
| Company | Akesobio Australia Pty Ltd |
| Licensee/Partner | None |
| Comments about company or candidate | Sep 2024: Adenocarcinoma Of The Gastroesophageal Junction, Gastric Cancer is approved for China on Sep 30, 2024 June 29 2022: Akeso Biopharma Inc. announced that its PD-1/CTLA-4 bi-specific antibody开坦尼® (Candonilimab injection, AK104) has received marketing approval from China Medical Products Administration (NMPA), for the treatment of relapsed or metastatic cervical cancer (R/M CC) patients who progressed on or after platinum-based chemotherapy. Aug 2021: The Company has received the approval from the National Medical Products Administration of the People’s Republic of China (‘‘China’’) to initiate a phase III pivotal registrational clinical trial for the global first-in-class novel drug Cadonilimab (PD-1/CTLA-4 bi-specific antibody, research and development code: AK104), an immuno-oncology therapy independently developed by the Company, in combination with oxaliplatin and capecitabine (‘‘XELOX’’) versus placebo in combination with XELOX for first-line treatment of advanced gastric adenocarcinoma or gastroesophageal junction cancer (clinical registration number: CTR20211567) and the national researchers’ conference has been successfully held. https://www.akesobio.com/en/media/akeso-news/21-8-3/ Company expects to file NDA in 2H 2021 (Slide 15, https://www.akesobio.com/media/1405/akesoplus2020plusarpluspresentation_ve-website2.pdf) for cervical cancer. The FDA has granted Fast Track Designation to AK104 for the treatment of advanced cervical cancer; Feb 2021 AK 104 receives Orphan Drug status for Cervical cancer (Stage IA2-IV) in USA In May 2020, AK104 obtained approval from NMPA to initiate a registrational trial for third-line treatment of patients with metastatic nasopharyngeal carcinoma. NCT04444167 Phase 1/2 study in hepatocellular carcinoma started in June 2020, and NCT04444141 Phase 1/2 study in peripheral T-cell lymphoma started in May 2020. NCT04380805 Phase 2 study in cervical cancer started July 2020. In January 2020, the company received the written consent from the FDA regarding the overall study design of a planned registrational trial of AK104 (PD-1/CTLA4) in the U.S. for 2L/3L cervical cancer patients and for potentially submitting NDA application to the FDA for cervical cancer via the accelerated approval pathway. Jan 2020: IND filed to start studies in cervical cancer. NCT04220307 Phase 2 in Metastatic Nasopharyngeal Carcinoma not yet recruiting as of first posting on Jan 7 2020. NCT04172454 Phase 1/2 in melanoma not yet recruiting as of Dec 20, 2019. NCT03852251 Phase 1/2 study started in January 2019. NCT03261011 Phase 1 study started in October 2017 still recruiting as of Aug 2018. |
| Full address of company | Address : 17/F, HWT Tower, No. 40, City Road Southbank, VIC 3006, Australia Australia Australia https://www.akesobio.com/en/about-us/contact-us/ |
Immune checkpoint inhibitor. Described as a PD-1 bispecific on company website. Tetrameric; derived from TETRABODY technology. Anti-PD1 antibody with additional 2 binding scFv-derived sites for CTLA-4 attached to termini of Fc. Mutations (L235A/L236A/G238A) were introduced into the Fc region to eliminate binding to FcγRs and C1q.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |