Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1716 |
| INN | Ivonescimab |
| Status | Approved |
| Drug code(s) | AK112, SMT112 |
| Brand name | 依達方® |
| mAb sequence source | mAb humanized |
| General Molecular Category | Bispecific |
| Format, general category | Appended Ig |
| Format details | IgG-(scFv)2 |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | PD-1, VEGF |
| Indications of clinical studies | Head and neck cancer, Cutaneous squamous cell carcinoma, Colorectal cancer, Hepatocellular Carcinoma, Small cell lung cancer, Triple-negative breast cancer, Ovarian cancer, Gynecological Tumors, Non-small cell lung cancer, 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) | June 01, 2019 |
| Start of Phase 2 | February 01, 2021 |
| Start of Phase 3 | January 15, 2022 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | 2024 |
| Date of first US approval | |
| INN, US product name | Ivonescimab |
| US or EU approved indications | None |
| Company | Akesobio Australia Pty Ltd |
| Licensee/Partner | Summit Therapeutics |
| Comments about company or candidate | May 24, 2024: Akeso, Inc. announced that ivonescimab, a first-in-class PD-1/VEGF bi-specific antibody independently developed by the Company, combined with chemotherapy for the treatment of epidermal growth factor receptor (EGFR) mutated locally advanced or metastatic non-squamous non-small cell lung cancer patients who have progressed after EGFR tyrosine kinase inhibitors (TKI) treatment, has been granted marketing approval by the National Medical Products Administration of the People's Republic of China . The approval of by the NMPA is based on AK112-301/HARMONi-A (CTR20213079), a randomized, double-blinded, multi-center Phase III clinical trial with primary endpoint of progression-free survival (PFS) and secondary endpoint of overall survival (OS) in China. https://www.marketscreener.com/quote/stock/AKESO-INC-111325370/news/Akeso-Inc-Receives-NMPA-s-Marketing-Approval-in-China-for-Ivonescimab-Injection-46817650/ Aug. 25, 2023: Akeso Inc. announced 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. 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. NCT05840016 Phase 3 due to start in June 2023. Phase 3 studies for Non-small cell lung cancer: NCT05184712 is recruiting as of May 25, 2023, NCT05499390 is recruiting as of November 10, 2022, NCT05840016 not yet recruiting as of May 3, 2023) CTR20230869 Phase 1/2 in colorectal cancer. Nov 2022: NMPA has granted Breakthrough Therapy Designation for ivonescimab combined with docetaxel for the treatment of I-O resistance non-small cell lung cancer patients who failed to respond to prior PD-L1 inhibitor combined with platinum-based doublet chemotherapy. This is the third breakthrough therapy designation for Akeso's ivonescimab for the treatment of non-small cell lung cancer. January 30, 2022 I Akeso, Inc. announces that the first patient was dosed in a Phase III registrational clinical trial of the Company's novel immuno-oncology drug, Ivonescimab (PD-1/VEGF bi-specific antibody, AK112), combined with chemotherapy versus placebo combined with chemotherapy for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (nsq-NSCLC) with EGFR mutation failed after EGFR-TKI treatment. NCT05184712 Phase 3 in NSCLC due to start in Jan 2022. NCT04999605 Phase 1/2 in ovarian cancer started in July 2021; NCT04736823 in NSCLC started in Feb 2021. Started Phase I trial for the treatment of advanced solid tumors in Australia in October 2019 (Slide 28, https://www.akesobio.com/media/1306/akeso-2020-interim-results-presentation.pdf) NCT04047290 Phase 1 in solid tumors. IND approval granted in June 2019. |
| 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/ |
AK112 is a PD-1/VEGF bispecific antibody; tetravalent; L234A, L235A mutations impair Fc effector functions
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |