Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 159 |
| INN | Sotrovimab |
| Status | Approved |
| Drug code(s) | VIR-7831, GSK4182136 |
| Brand name | Xevudy® |
| 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 | kappa |
| 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 | COVID-19 |
| Primary therapeutic area | Infectious diseases |
| Most advanced stage of development (global) | Approved EU, Japan, Australia |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | August 24, 2020 |
| Start of Phase 2 | |
| Start of Phase 3 | |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | 2021 |
| Date of first US approval | |
| INN, US product name | Sotrovimab |
| US or EU approved indications | Treatment of adults and adolescents (aged 12 years and over and weighing at least 40kg) with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19. |
| Company | Humabs Biomed SA subsidiary of Vir Biotechnology Inc. |
| Licensee/Partner | GlaxoSmithKline |
| Comments about company or candidate | Emerency use authorization granted but withdrawn in US Positive opinion issued Dec 16 and immediately approved by EC; Sotrovimab is now approved in the European Union (EU) for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40kg) with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19. On March 27, 2021, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for sotrovimab (VIR-7831; GSK4182136) for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progression to severe COVID-19, including hospitalization or death. The EUA was issued to GlaxoSmithKline. Phase 2/3 study of VIR-7831, a SARS-CoV-2 neutralizing antibody, launched in Aug, with preliminary data expected before year-end. Phase 2 study of another SARS-CoV-2 neutralizing antibody, VIR-7832, to launch later this year. https://investors.vir.bio/news-releases/news-release-details/vir-biotechnology-provides-corporate-update-and-reports-second July 6, 2020: Vir Biotechnology Incannounced that it has filed a registration statement on Form S-1 with the Securities and Exchange Commission (SEC) relating to a proposed underwritten public offering of 6,200,000 shares of its common stock, for gross proceeds of USD287.5 million. Vir Biotechnology intends to use the proceeds to fund the following clinical trials through completion: VIR-7831 - its planned IND for SARS-CoV-2 and assuming regulatory clearance, subsequent Phase II/III clinical trial; VIR-7832 - its planned IND or equivalent submission for SARS-CoV-2 and assuming regulatory clearance, subsequent Phase II clinical trial; VIR-2703 antisense RNAi (partner Alnylam Pharmaceuticals) - its ongoing preclinical studies for SARS-CoV-2; May 29, 2020: Vir Biotechnology, Inc. announced that is has finalized a process development and manufacturing agreement with Biogen Inc. (Nasdaq: BIIB) based on the letter of intent that the companies announced in March.Vir’s SARS-CoV-2 antibody development candidates, VIR-7831 and VIR-7832, have demonstrated high affinity for the SARS-CoV-2 spike protein and the ability to neutralize SARS-CoV-2 in live-virus cellular assays. The execution of this definitive agreement allows Vir to advance the development of its antibody candidates and complements its existing manufacturing agreements with WuXi Biologics (stock code: 2269.HK) and Samsung Biologics Co., Ltd. (207940.KS). Under the terms of the agreement, Biogen and Vir will collaborate to develop highly productive clonal cell lines and clinical and commercial manufacturing processes for Vir’s SARS-CoV-2 antibody candidates. These processes are designed to be transferrable to global biomanufacturing facilities designed for advanced biologics production. May 18, 2020: Vir Biotechnology, Inc. announced the publication of research findings from the company’s efforts to develop therapeutics for COVID-19 in the May 18, 2020 issue of the journal Nature. The paper, entitled “Cross-neutralization of SARS-CoV and SARS-CoV2 by a human monoclonal antibody” (Pinto, et al., Nature), details the identification and characterization of S309, an antibody isolated from a patient who recovered from severe acute respiratory syndrome (SARS) in 2003, which has been shown to prevent SARS-CoV-2 live virus infection of cells. Vir is advancing two clinical development candidates based on the S309 antibody as potential therapeutics for COVID-19, VIR-7831 and VIR-7832, in collaboration with GlaxoSmithKline plc. https://www.nature.com/articles/s41586-020-2349-y April 6, 2020, GlaxoSmithKline plc and Vir Biotechnology, Inc. announced they have signed a binding agreement to enter into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. During the agreement period, generally, subject to certain rights granted to WuXi Biologics (Hong Kong) Limited (“WuXi”) under existing agreements between WuXi and VIR, the parties will have an exclusive research collaboration with respect to antibody products directed to SARS-CoV-2 or to any other coronavirus The collaboration will use Vir’s proprietary monoclonal antibody platform technology to accelerate existing and identify new anti-viral antibodies that could be used as therapeutic or preventative options to help address the current COVID-19 pandemic and future outbreaks.The initial focus of the collaboration will be to accelerate the development of specific antibody candidates identified by the Vir platform, VIR-7831 and VIR-7832, that have demonstrated high affinity for the SARS-CoV-2 spike protein and are highly potent in neutralising SARS-CoV-2 in live virus-cellular assays. Subject to regulatory review, the companies plan to proceed directly into a phase 2 clinical trial within the next three to five months. April 9, 2020 I Samsung Biologics and Vir Biotechnology, Inc. announced a manufacturing agreement under which Samsung Biologics will perform large scale manufacturing services for Vir's SARS-CoV-2 monoclonal antibody (mAb) program. Samsung Biologics is expected to commence its manufacturing as early as October with the first engineering run, with potential commercial batches to be manufactured starting in 2021 in Plant 3. Vir's lead SARS-CoV-2 mAb development candidates, VIR-7831 and VIR-7832, have demonstrated high affinity for the SARS-CoV-2 spike protein and are highly potent in neutralizing SARS-CoV-2 in live-virus cellular assays. Vir plans to proceed directly into a phase 2 clinical trial within the next three to five months. Today's agreement builds on Vir's previously announced manufacturing agreement with WuXi Biologics (stock code: 2269.HK) and its letter of intent with Biogen, Inc. March 25: Candidate for clinical study ready in 3-5 months. |
| Full address of company | 1800 Owens Street Suite 900 San Francisco, CA 94158 United States North America United States of America https://www.vir.bio/contact/ |
The initial antibodies under the Antibody Program will be VIR-7831 and VIR-7832, which have demonstrated high affinity for the SARS-CoV-2 spike protein and are highly potent in neutralizing SARS-CoV-2 in live virus-cellular assays. These two molecules appears to be the same assets developed as part of agreements with Xencor, Biogen and WuXi. Anti-CoV Ab with half-life extension mutations and vaccinal mutations; 2nd candidate has only half-life extention mutations Two Anti-CoV mAb candidates, with half-life extension mutations and vaccinal mutations. March 25, 2020: Xencor announced it has entered into a technology license agreement with Vir Biotechnology in which Vir will have non-exclusive access to Xencor’s Xtend Fc technology to extend the half-life of novel antibodies that Vir is investigating as potential treatments for patients with COVID-19, the disease caused by the novel coronavirus SARS-CoV-2. VIR platform: We have established a robust method for capitalizing on unusually successful immune responses naturally occurring in people who are protected from, or have recovered from, infectious diseases. We identify rare antibodies from survivors that have the potential to treat and prevent rapidly evolving and/or previously untreatable pathogens via direct pathogen neutralization and immune system stimulation. We engineer the fully-human antibodies that we discover to enhance their therapeutic potential. In May, Nature published “Cross-neutralization of SARS-CoV-2 by a human monoclonal SARS-CoV antibody” (Pinto, et al.), detailing the identification and characterization of S309, the parent molecule of VIR-7831 and VIR-7832.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |