Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 2095 |
| INN | Feladilimab |
| Status | Terminated |
| Drug code(s) | GSK3359609 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG4 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | ICOS |
| Indications of clinical studies | Head and neck cancer, Non-small cell lung cancer, advanced solid tumors, multiple myeloma (Phase 1/2 DREAMM5 study) |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Terminated at Phase 3 |
| Status | Inactive |
| Start of clinical phase (IND filing or first Phase 1) | June 30, 2016 |
| Start of Phase 2 | November 26, 2018 |
| Start of Phase 3 | November 21, 2019 |
| 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 | GSK |
| Licensee/Partner | None |
| Comments about company or candidate | Not listed in GSK pipeline dated April 27, 2022 or Feb 2023. Listed as Phase 1 for multiple myeloma as of GSKQ3 2021 update. GSK Q2 2021 update: The ENTRÉE-Lung sub study 1 investigating feladilimab plus docetaxel versus docetaxel alone did not meet its primary endpoint at the interim analysis. April 2021: GlaxoSmithKline has stopped two clinical trials of feladilimab in combination with Keytruda after an interim review. Other studies of the ICOS agonist are continuing, but the future of the program is now in doubt. Feladilimab, formerly known as GSK3359609, is designed to stimulate and grow cytotoxic T cells by acting on ICOS. The mechanism of action suggests ICOS agonists may enhance checkpoint inhibitors, leading GSK and Merck to start studying the combination of feladilimab and PD-1 drug Keytruda. The theory took a hit late last year when Jounce Therapeutics stopped a trial that was testing its rival ICOS candidate in combination with Bristol Myers Squibb’s CTLA-4 inhibitor Yervoy. Now, GSK has dealt another blow to the cases for ICOS agonists. After seeing interim results from a trial in PD-L1-positive recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) patients, the independent data monitoring committee recommended stopping the INDUCE-3 study. https://www.gsk.com/en-gb/media/press-releases/gsk-provides-update-on-feladilimab-an-investigational-inducible-t-cell-co-stimulatory-icos-agonist/ Phase 3 NCT04128696 study in head and neck cancer started recruiting Nov 21, 2019. Listed as Phase 2 in GSK pipeline accessed Aug 12, 2019. NCT03693612 Phase 2 study started in Nov 2018. Start of NCT02723955 Phase 1 announced June 30, 2016; still recruiitng as of Aug 2018. A first in class ICOS agonist antibody, GSK3359609, being developed in collaboration with INSERM, is focused on enhancing patients’ anti-tumour T-cell response and is expected to enter the clinic in Q1 2016. Listed as Phase 1/2 in GSK press release dated July 26 2017 (https://www.gsk.com/media/3866/press-release-gsk-delivers-further-progress-in-q2-and-sets-out-new-priorities-for-the-group-26-july-2017.pdf). |
| Full address of company | 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom Europe United Kingdom https://www.gsk.com/en-gb/contact-us/ |
Immune checkpoint inhibitor. anti-Inducible T cell Co-Stimulator (ICOS) receptor agonist antibody. GSK3359609 is a humanized IgG4 antibody selected for its potent binding agonist activity against human ICOS (INDUCE-1: a phase I open-label study of GSK3359609, an ICOS agonist antibody, administered alone and in combination with pembrolizumab in patients with selected, advanced solid tumors [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2017; 2017 Apr 1-5; Washington, DC. Philadelphia (PA): AACR; Cancer Res 2017;77(13 Suppl):Abstract nr CT039. doi:10.1158/1538-7445.AM2017-CT039). S228P, L235E mutations
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |