Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1424 |
| INN | Tobevibart |
| Status | Clinical |
| Drug code(s) | VIR-3434, BRII-877 |
| Brand name | None |
| 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 | None |
| Target(s) | HBV (HBsAg) |
| Indications of clinical studies | Chronic hepatitis delta, chronic hepatitis B infection |
| Primary therapeutic area | Infectious diseases |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | May 15, 2020 |
| Start of Phase 2 | July 15, 2021 |
| Start of Phase 3 | March 01, 2025 |
| 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 | Vir Biotechnology Inc. |
| Licensee/Partner | Brii Biosciences, Xencor |
| Comments about company or candidate | Mar 2025: First patient enrolled in ECLIPSE 1 Phase 3 clinical trial evaluating combination of tobevibart and elebsiran for chronic suppressive treatment. Tobevibart and elebsiran in chronic hepatitis delta received U.S. FDA Breakthrough and Fast Track designations and EMA PRIME and Orphan Drug designations Nov 2024: Vir Biotechnology, Inc. announced positive results from the SOLSTICE Phase 2 clinical trial. Following a recent FDA meeting, Phase 3 ECLIPSE registrational program to begin in the first half of 2025. (https://investors.vir.bio/news/news-details/2024/Vir-Biotechnology-Presents-Positive-Chronic-Hepatitis-Delta-Clinical-Trial-Data-and-Announces-Initiation-of-Phase-3-Registrational-Program/default.aspx). Vir Biotechnology receives positive opinion on orphan drug designation for tobevibart and elebsiran in chronic hepatitis delta from European Medicines Agency. June 2024: Vir Biotechnology, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application and granted Fast Track designation for the combination of tobevibart and elebsiran for the treatment of chronic hepatitis delta infection. https://www.businesswire.com/news/home/20240626614229/en/Vir-Biotechnology-Receives-FDA-IND-Clearance-and-Fast-Track-Designation-for-Tobevibart-and-Elebsiran-for-the-Treatment-of-Chronic-Hepatitis-Delta-Infection NCT05461170 Phase 2 SOLSTICE study started in Sep 2022. July 2022: Brii Biosciences (Brii Bio) has exercised an option for the acquisition of exclusive development and marketing rights for Vir Biotechnology’s investigational antibody, VIR-3434, for Hepatitis B in Greater China, under a partnership agreement. NCT04856085 Phase 2 study still recruiting as of last update in April 2022. July 15, 2021 I Vir Biotechnology, Inc. announced that the first patient has been dosed in the NCT04856085 Phase 2 MARCH (Monoclonal Antibody siRNA Combination against Hepatitis B) trial evaluating VIR-2218 (HBV-targeting siRNA) together with VIR-3434 for the treatment of patients with chronic hepatitis B virus (HBV) infection – a combination designed to achieve a functional cure. NCT04423393 is a Phase 1 study in healthy volunteers and patients with Chronic Hepatitis B. May 27, 2020: Vir Biotechnology, Inc. announced the initiation of a Phase 1 clinical trial of VIR-3434, an investigational monoclonal antibody that neutralizes hepatitis B virus (HBV) and has been engineered to potentially also act as a therapeutic vaccine. The commencement of first-in-human dosing marks the start of Vir’s second clinical program aimed at a functional cure for HBV. |
| Full address of company | San Francisco, California, United States North America United States of America https://www.vir.bio/contact/ |
VIR-3434 is an HBV-neutralizing monoclonal antibody designed to block entry of all 10 genotypes of HBV into hepatocytes, and also to reduce the level of virions and subviral particles in the blood. It has also been Fc engineered to include the XX2 “vaccinal mutation,” for which Vir has licensed exclusive rights for all infectious diseases. The vaccinal mutations incorporated into the Fc domain of VIR-3434 act in concert to potentially trigger the correct FcGamma receptors on dendritic cells, resulting in their maturation. Targeting a conserved region of HBsAg; engineered to have an extended half-life and to potentially function as a T cell vaccine against HBV in infected patients.
Uses Xencor's Xtend technoloy.
By engineering antibodies with modified Fc domains to enhance binding to specific Fc receptors on innate immune cells, investigators observed an enhanced protective immune response. Certain modifications (GAALIE variants) were associated with activation of dendritic cells, as well as antiviral effector T-cells, indicating induction of the adaptive arm of the immune system, which is responsible for long-term immunity. Based on this research, monoclonal antibodies programmed with improved effector function represent a potential new approach in the design of therapeutic antibodies for both the prevention and treatment of infectious diseases.
Herbert “Skip” Virgin, M.D., Ph.D., study co-author and executive vice president, research, and chief scientific officer of Vir: “These data may have significant implications across a wide range of infectious diseases, and we look forward to exploring the vaccinal potential of the GAALIE-engineered antibodies we are advancing through clinical development – VIR-3434 for chronic hepatitis B and VIR-7832 for SARS-CoV-2.”
GAALIE variants discussed in: Bournazos, S., Corti, D., Virgin, H.W. et al. Fc-optimized antibodies elicit CD8 immunity to viral respiratory infection. Nature (2020). https://doi.org/10.1038/s41586-020-2838-z
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |