Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 691 |
| INN | Belrestotug |
| Status | Clinical |
| Drug code(s) | GSK4428859, EOS884448, EOS-448, RCA-2 |
| 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) | TIGIT |
| Indications of clinical studies | Multiple myeloma, non-small cell lung cancer, Solid tumors |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | January 15, 2019 |
| Start of Phase 2 | October 01, 2022 |
| Start of Phase 3 | June 15, 2024 |
| 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 | iTEOS Therapeutics |
| Licensee/Partner | GSK |
| Comments about company or candidate | June 17, 2024 I iTeos Therapeutics, Inc. and its development partner GSK, have initiated the first, global Phase 3 registration study of belrestotug + dostarlimab doublet versus placebo + pembrolizumab in patients with previously untreated, unresectable, locally advanced or metastatic PD-L1 selected non-small cell lung cancer (NCT06472076) NCT05565378 Phase 2 platform study that includes GSK4428859A started in Oct 2022 recruiting as of last update in Mar 2023 NCT05289492 Phase 1/2 in multiple myeloma due to start in May 2022. June 14, 2021 iTeos Therapeutics and GlaxoSmithKline plc announced an agreement to co-develop and co-commercialise EOS-448, an anti-TIGIT monoclonal antibody currently in phase I development as a potential treatment for patients with cancer. Feb 2020: iTeos Therapeutics (Belgium) announced that it has enrolled the first patient in its Phase I/II study (NCT04335253) with EOS884448 (EOS-448), the company’s investigational ADCC-enabled antagonist anti-TIGIT antibody drug candidate. iTeos expects reporting of initial safety and efficacy results in the first half of 2021. NCT03739710 Phase 1/2 in NSCLC started in Jan 2019; study later transitioned to Phase 2. iTeos is a spin-off of the Ludwig Institute for Cancer Research (LICR) and the de Duve Institute at the Université catholique de Louvain and is based on innovative cancer research discoveries licensed from LICR. https://www.sec.gov/Archives/edgar/data/1808865/000119312520198657/d892230d424b4.htm |
| Full address of company | Watertown, MA 02472, United States North America United States of America https://www.iteostherapeutics.com/contact/ |
Immune checkpoint modulator. EOS-448 is a novel fully human IgG1 mAb against the TIGIT receptor; EOS884448 is an antagonist antibody against human TIGIT. Preclinical studies show its potency to restore T cell function and to preferentially deplete Treg cells in cancer patient material. ADCC/ADCP-enabling isotypes of a-TIGIT surrogate Ab show potent monotherapy efficacy in murine tumor models that correlates to increased T cell activation and reduced Treg infiltration of tumors. EOS884448 demonstrates classical human IgG pharmacokinetics profile and a good developability profile. Preclinical results reported at SITC in Nov 2018 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6220479/
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |