Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1210 |
| INN | Vamikibart |
| Status | Clinical |
| Drug code(s) | RO7200220, RG6179, EBI-031 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG2 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | IL-6 |
| Indications of clinical studies | Uveitic Macular Edema, Diabetic Macular Edema |
| Primary therapeutic area | Ophthalmic disorders |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | June 15, 2016 |
| Start of Phase 2 | December 15, 2021 |
| Start of Phase 3 | January 13, 2023 |
| 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 | Sesen Bio |
| Licensee/Partner | Hoffmann-La Roche |
| Comments about company or candidate | Oct 2024: Listed as possible marketing submission in 2026, growth driver in Roche Q3 update (https://assets.roche.com/f/176343/x/31805a2578/irp231024.pdf) Mar 2023: Sesen Bio has merged with Carisma Therapeutics to form Carisma Therapeutics Phase 3 studies for Uveitic macular edema (NCT05642325, NCT05642312) are recruiting as of May 23-25, 2023 NCT05642312 Phase 3 studies in Uveitic Macular Edema started in Jan 2023. NCT05642325 Phase 3 studies in Uveitic Macular Edema due to started in March 2023. 2 Phase 2 studies in Diabetic Macular Edema recuiting as of Dec 2021. Phase 1 DOVETAIL study started in Q3 2019. On July 15, 2022, Sesen executed an asset purchase agreement (the “Roche Asset Purchase Agreement”) with Roche for legacy Interleukin-6 (IL-6) antagonist antibody technology owned by Sesen Bio. Pursuant to the Roche Asset Purchase Agreement, Roche purchased all patent rights and know-how related to the monoclonal antibody EBI-031 and all other IL-6 antagonist monoclonal antibody technology owned by Sesen Bio for up to $70 million. This includes a $40 million payment made by Roche to the Company upon execution of the Roche Asset Purchase Agreement, and an additional $30 million payable to Sesen Bio upon Roche’s initiation of a Phase 3 clinical trial with EBI-031 for a defined indication if initiated prior to December 31, 2026. IND filed in June 2016; NCT02842541 Phase 1 study withdrawn prior to enrollment Sesen Bio was formally Eleven Biotherapeutics |
| Full address of company | 245 First Street Suite 1800 Cambridge, MA 02142 United States North America United States of America https://pitchbook.com/profiles/company/52624-72#overview |
Molecular format included in "Pharmacological agents in development for diabetic macular edema" but this article was retracted for legal reasons. mAb for diabetic macular edema; longer half life. EBI-031 is a novel inhibitor of the cytokine IL-6 and is an optimized version of the company's anti-IL-6 antibody, EBI-029. The company believes that 031 has the identical binding site on IL-6 and same mechanism of action as 029. The company designed 031 to block IL-6 signaling at much lower concentrations that 029, potentially increasing the potency and potentially extending the time between required administrations. Humanized monoclonal antibody that potently binds interleukin-6 (IL-6) and inhibits all known forms of IL-6 cytokine signaling, for treatment of ocular diseases.
| Anticipated events | Possible marketing submissions in 2026; two Phase 3 studies have primary completion dates in June 2025 |
| Factor(s) contributing to discontinuation | None |