Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 250 |
| INN | Gumokimab |
| Status | Clinical |
| Drug code(s) | AK111 |
| Brand name | None |
| mAb sequence source | mAb chimeric/humanized |
| General Molecular Category | Naked monospecific |
| 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) | IL-17A |
| Indications of clinical studies | Psoriasis, ankylosing spondylitis |
| 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) | July 01, 2019 |
| Start of Phase 2 | April 28, 2021 |
| Start of Phase 3 | March 15, 2023 |
| 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 | NCT06378697 Phase 3 in ankylosing spondylitis started in Nov 2023. CTR20230111 / NCT06066125 Phase-3 clinical trial in Plaque psoriasis (Treatment-resistant) in China (SC) started in April 2023. NCT05096364 Phase 2 in psoriasis started in April 2021. Phase 2 in Ankylosing Spondylitis started in June 2021. First patient with moderate-to-severe plaque psoriasis was dosed with AK111 in Phase Ib study in China (June 2020); Phase 1 as per company pipeline update dated Aus 2020. https://www.akesobio.com/media/1306/akeso-2020-interim-results-presentation.pdf In addition to psoriasis, we may potentially expand our evaluation of AK111 into additional indications such as ankylosing spondylitis (AS) and axial spondyloarthritis (axSpA). We have completed a Phase I clinical trial of AK111 in New Zealand. We have also obtained an IND approval for psoriasis in China and plan to enroll patients in a Phase Ib trial in the first half of 2020. 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/ |
Target is IL-17A according to https://www.akesobio.com/en/media/akeso-news/20210929/
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |