Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 303 |
| INN | None |
| Status | Clinical |
| Drug code(s) | ANX007 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Fragment |
| Format details | Fab |
| Isotype (Fc) | None |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | Complement C1q |
| Indications of clinical studies | Geographic Atrophy, Primary Open-angle Glaucoma |
| Primary therapeutic area | Ophthalmic disorders |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | March 23, 2018 |
| Start of Phase 2 | February 26, 2021 |
| Start of Phase 3 | March 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 | Annexon Inc. |
| Licensee/Partner | None |
| Comments about company or candidate | Aug. 05, 2024 -- Annexon, Inc. announced patient dosing was initiated in the global pivotal Phase 3 ARCHER II trial (https://ir.annexonbio.com/news-releases/news-release-details/annexon-provides-update-archer-ii-global-registrational-program) NCT06510816 Phase 3 study due to start in July 2024 Oct 2023: European Medicines Agency has granted Priority Medicine (PRIME) designation to ANX007 for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration. Aug 2022: The U.S. Food and Drug Administration granted Fast Track designation to ANX007, an investigational antibody antigen-binding-fragment (Fab), for the treatment of geographic atrophy. NCT04656561 Phase 2 started in Feb 2021. NCT04188015 Phase 1 study completed in June 2019. NCT03488550 Phase 1 started in March 2018 |
| Full address of company | 1400 Sierra Point Parkway, Building C, 2nd Floor, Brisbane, CA 94005 North America United States of America https://annexonbio.com/ |
ANX007 is a clinical-stage investigational monoclonal antibody antigen-binding fragment (Fab) for the treatment of patients with complement-mediated neurodegenerative ophthalmic diseases. Formulated for IVT administration, ANX007 is designed to potently bind to C1q and inhibit activation of all downstream components of the classical complement cascade, including C3 and C5, but to not interfere with the normal function of C3 and C5 as part of other complement pathways. Recombinant humanized antigen binding fragment (Fab) of a monoclonal antibody. Composed of one VH and CH1 segment of an IgG1 heavy chain covalently linked to one kappa light chain. Molecular weight - ~48 kDa.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |