Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 249 |
| INN | Pulocimab |
| Status | Clinical |
| Drug code(s) | AK109 |
| Brand name | None |
| mAb sequence source | mAb 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) | VEGFR2 |
| Indications of clinical studies | Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, Solid tumors |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | June 15, 2020 |
| Start of Phase 2 | November 03, 2021 |
| Start of Phase 3 | June 06, 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 | NCT06341335 / CTR20241225 Phase 3 in Gastric or Gastroesophageal Junction Adenocarcinoma started in June 2024 NCT04982276 Phase 1/2 in Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma recruiting as of last update in Oct 2022 NCT05142423 is a Phase 1/2 study in solid tumors started in Nov 2021 recruiting as of last update in Oct 2022. NCT04547205 Phase 1 study in solid tumors started in June 2020 completed in Oct 2022. First patient was dosed with AK109 in Phase I study in China (June 2020) (Slide 30, https://www.akesobio.com/media/1306/akeso-2020-interim-results-presentation.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/ |
AK109 has the same V domain sequences but different huIgG1 allotype compared to ramucirumab.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |