Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 351 |
| INN | Sipavibart |
| Status | Regulatory review |
| Drug code(s) | AZD3152 |
| Brand name | (Pending) |
| mAb sequence source | mAb - source TBD |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | lambda |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Human B cells (Convalescent source) |
| Target(s) | SARS-CoV-2 (spike protein) |
| Indications of clinical studies | Pre Exposure Prophylaxis of COVID-19 |
| Primary therapeutic area | Infectious diseases |
| Most advanced stage of development (global) | Regulatory review EU, Japan |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | December 30, 2022 |
| Start of Phase 2 | |
| Start of Phase 3 | December 30, 2022 |
| 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 | AstraZeneca |
| Licensee/Partner | RQ Biotechnology |
| Comments about company or candidate | July 1 2024: AstraZeneca has announced that their Marketing Authorisation Application for sipavibart has been accepted under an accelerated assessment procedure by the European Medicines Agency (EMA), for the pre-exposure prophylaxis (prevention) of COVID-19 in immunocompromised patients. May 2024: Supernova Phase III Trial of Sipavibart Long-Acting Antibody Met Primary Endpoints in Preventing COVID-19 in Immunocompromised Patient Population; AstraZeneca is in dialogue with regulatory authorities on potential authorisation or approval pathways. https://www.astrazeneca.com/media-centre/press-releases/2024/sipavibart-ema-regulatory-submission-accepted-under-accelerated-assessment-for-covid-19-prevention.html Phase 3 study for Pre-exposure prophilaxis of COVID-19 (NCT05648110) is recruiting as of May 22, 2023. The aim of the Phase I/III study (Parent Study) will be to evaluate the safety, efficacy and neutralizing activity of AZD3152 compared with comparator for pre exposure prophylaxis of COVID-19, and separately evaluate the safety and PK of AZD5156, a combination of AZD3152 and AZD1061. NCT05872958 Phase 1 of AZD3152 due to start in June 2023. Preclinical data presented at Clinical Microbiology & Infectious Diseases (ECCMID), 15 – 18 April 2023. NCT05648110 is a Phase I/III Randomized, Double Blind Study to Evaluate the Safety and Neutralizing Activity of AZD5156 for Pre Exposure Prophylaxis of COVID 19 in Participants With Conditions Causing Immune Impairment. AstraZeneca licenced AZD3152 from RQ Bio in May 2022. |
| Full address of company | Cambridge, United Kingdom Europe United Kingdom https://www.astrazeneca.com/our-company/contact-us.html |
Long-acting antibody. The monoclonal antibody, discovered by RQ Biotechnology, licensed and further developed by AstraZeneca (AZD3152), has excellent properties for clinical development, and was isolated from vaccinated volunteers after they had an Omicron-BA.1 infection. AZD3152 has broad and potent neutralising activity across all known SARS‑CoV-2 variants [2], and forms part of a new investigational combination (AZD5156) for prevention of COVID-19. AZD5156 is a mixture of AZD3152 and cilgavimab (a component of Evusheld).
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |