Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 254 |
| INN | Manfidokimab |
| Status | Clinical |
| Drug code(s) | AK120 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG4 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | IL-4R alpha |
| Indications of clinical studies | Asthma, Atopic Dermatitis, Phase 1 in healthy subjects |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | December 15, 2019 |
| Start of Phase 2 | September 15, 2021 |
| Start of Phase 3 | April 15, 2024 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | None |
| Date of first US approval | |
| INN, US product name | None |
| US or EU approved indications | None |
| Company | Akesobio Australia Pty Ltd |
| Licensee/Partner | None |
| Comments about company or candidate | NCT06383468 Phase 3 in atopic dermatitis started in Apr 2024 NCT06092762 Phase 2 in atopic dermatitis due to start in Nov 2023. Mar 2023: Listed as Phase 2 asset in company pipeline. NCT05155020 Phase 2 in asthma started in Feb 2022 terminated in Aug 2022 (The clinical development strategy has been changed) Sep 2021: Akeso, Inc. announces that the Company’s self-developed innovative drug candidate, IL-4Ra monoclonal antibody , initiated a global phase II clinical study for the treatment of moderate-to-severe atopic dermatitis which was approved by the Food and Drug Administration of the United States NCT05048056 in atopic dermatis started in Sep 2021 recruiting as of last update in July 2022. NCT04256174 Phase 1 in healthy subjects started June 15, 2020 completed in Oct 2021. In December 2019, we submitted an IND application in Australia for AK120. https://www1.hkexnews.hk/app/sehk/2020/101281/a103181/sehk20020303464.pdf |
| 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/ |
AK120 is a humanized immunoglobulin G subclass 4 (IgG4) monoclonal antibody (mAb) directed against the IL-4 receptor alpha (IL-4Rα) subunit shared by the IL-4 and IL-13 receptor complexes. https://pubmed.ncbi.nlm.nih.gov/37668898/
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |