Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 276 |
| INN | None |
| Status | Clinical |
| Drug code(s) | ALXN2220, NI006, NI301A |
| Brand name | None |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | TBD |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | Amyloid transthyretin |
| Indications of clinical studies | Transthyretin amyloid cardiomyopathy |
| Primary therapeutic area | Cardiovascular / hemostasis disorders |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | February 10, 2020 |
| Start of Phase 2 | |
| Start of Phase 3 | January 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 | Neurimmune AG |
| Licensee/Partner | AstraZeneca |
| Comments about company or candidate | NCT06183931 Phase 3 started as per AZ presentation at Jan 2024 JMP conference (https://www.astrazeneca.com/content/dam/az/Investor_Relations/events/AZ-JPM-2024-presentation.pdf) ALXN2220 was granted orphan drug designation by the FDA for the treatment of patients with ATTR-CM84. (September 2023) Listed as Phase 1 asset in AZ pipeline accessed Feb 2023. March 2022: AstraZeneca and Neurimmune close exclusive global collaboration and licence agreement to develop and commercialise NI006 July 2021: AstraZeneca completed the acquisition of Alexion Pharmaceuticals, Inc NCT04360434 Phase 1 study. February 27, 2020 – Neurimmune AG, the discoverer of aducanumab and cinpanemab, announced enrollment of the first patient in a Phase 1 clinical trial to evaluate NI006 in transthyretin amyloid cardiomyopathy (ATTR cardiomyopathy). ATTR cardiomyopathy is characterized by the intramyocardial deposition of TTR amyloid fibrils that increase heart wall thickness and cause heart muscle stiffness leading to ventricular dysfunction. |
| Full address of company | Wagistrasse 18, 10th floor, 8952 Schlieren / Zurich, Switzerland Europe Switzerland https://www.neurimmune.com/contact |
NI006 is a human monoclonal antibody that binds with high affinity to TTR amyloid, but not to the physiological forms of transthyretin. https://www.nejm.org/doi/10.1056/NEJMoa2303765?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed and is also know as NI301A https://www.nature.com/articles/s41467-021-23274-x
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |