Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 2255 |
| INN | Simaravibart |
| Status | Terminated |
| Drug code(s) | MAD0004J08 |
| 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 | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | SARS-CoV-2 (spike protein) |
| Indications of clinical studies | COVID-19 |
| Primary therapeutic area | Infectious diseases |
| Most advanced stage of development (global) | Terminated at Phase 2/3 |
| Status | Inactive |
| Start of clinical phase (IND filing or first Phase 1) | March 01, 2021 |
| Start of Phase 2 | |
| Start of Phase 3 | June 06, 2021 |
| 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 | Toscana Life Sciences Sviluppo s.r.l. |
| Licensee/Partner | None |
| Comments about company or candidate | Assumed to be terminated. In January 2023 Toscana Life Sciences announced that they temporary paused the trial because the J08 antibody has demonstrated reduced efficacy in neutralizing the Omicron variants. They are already looking at other antibodies which might be useful against these new variants, maybe in combination with J08. https://www.toscanalifesciences.org/it/comunicati-stampa/toscana-life-sciences-sviluppo-sospende-temporaneamente-larruolamento-di-nuovi-pazienti-nei-test-clinici-sullanticorpo-monoclonale-anti-covid-19/ NCT04952805 is a Phase 2/3 study to Select the Dose and Evaluate Safety and Efficacy of Monoclonal Antibody in Adult With Recently Diagnosed Asymptomatic to Moderately Severe COVID-19; active not recruiting as of Feb 2022. NCT04932850 is A Phase I Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of Anti-SARS-CoV-2 Monoclonal Antibody MAD0004J08 in Healthy Adults. |
| Full address of company | Via Fiorentina, 1, 53100 Siena – ITALY Europe Italy https://www.toscanalifesciences.org/en/ |
Engineered immunoglobulin fragment crystallizable (Fc) region (M428L/N434S9,10 and L234A/L235A/ P329G11) to increase its serum half-life while silencing the Fc activity to abrogate binding to FcγRs and eliminate possible risks of antibody-dependent enhancement (ADE) of disease (https://www.nature.com/articles/s41467-022-29909-x) Described in recent publication in Cell, "Extremely potent human monoclonal antibodies from convalescent COVID-19 patients" which reports the main data produced by the team of researchers of the Toscana Life Sciences Foundation together with VisMederi, INMI Spallanzani, University of Siena and Turin, Imperial College London (UK), University of Kent (UK), University of Georgia (USA), The Scripps Research Institute of La Jolla (CA, USA).
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |