Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1209 |
| INN | Astegolimab |
| Status | Clinical |
| Drug code(s) | RO7187807, MSTT1041A, RG6149, AMG282 |
| Brand name | None |
| mAb sequence source | mAb human |
| 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-33R |
| Indications of clinical studies | Atopic Dermatitis, Chronic Obstructive Pulmonary Disease, COVID-19, Asthma, Chronic Rhinosinusitis With Nasal Polyps |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | August 15, 2013 |
| Start of Phase 2 | September 15, 2016 |
| Start of Phase 3 | December 29, 2022 |
| 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 | Amgen |
| Licensee/Partner | Genentech |
| Comments about company or candidate | Roche plans regulatory submission in COPD in 2025 (https://assets.cwp.roche.com/f/176343/x/14b2fa29c8/irp240424.pdf) NCT05878769 Phase 3 study in COPD started in June 2023. Listed as Phase 3 in Roche Q1 2023 update. NCT05595642 Phase 2/3 ARNASA study in COPD started in Dec 2022. April 2021: Roche has cut a series of experimental lung drugs from its pipeline, including two midstage COVID-19 assets. The first drug, an Amgen-licensed anti-ST2 antibody known as astegolimab (aka RG6149), works by stopping the binding of IL-33 to ST2. This has already flopped in asthma, like so many other IL-33s, but the Swiss giant thought it could help COVID patients with pneumonia. The trial was started last year and was slated to end in January; presumably, the results were not good, as Roche said in its first-quarter results presentation (PDF) today that it has been “removed from phase 2.” NCT04386616 Phase 2 study in COVID-19 pneumonia not yet recruiting when posted on May 13, 2020. Listed as Phase 2 in Roche pipeline dated July 25, 2019. NCT02918019 Phase 2 study started in Sep 2016 completed in July 2019. NCT03615040 Phase 2 study in COPD exacerbation started recruiting in Oct 2018. Listed as advanced to Phase 2 in Roche pipeline dated Oct 2, 2016. Jan 2016: Genentech plans to run Phase II trials of the antibody to treat asthma and chronic obstructive pulmonary disease (COPD), but did not provide a timeline. NCT01928368 recruiting as of Oct 2013 |
| Full address of company | Thousand Oaks, California, United States North America United States of America https://www.amgen.com/ |
AMG 282 is a human antibody that inhibits binding of IL-33 to the ST2 receptor. immunoglobulin G2-kappa, anti-[Homo sapiens IL1RL1 (interleukin 1 receptor like 1, DER4, FIT-1, growth stimulation expressed 2 gene, ST2, IL33R)], Homo sapiens monoclonal antibody; gamma2 heavy chain Homo sapiens (1-447) [VH (Homo sapiens IGHV5-51*01 (95.9%) -(IGHD) - IGHJ6*01(94.1%)) [8.8.14] (1-121) -Homo sapiens IGHG2*01 (100%) (CH1 (122-219), hinge 1-12 (220-231), CH2 (232-340), CH3 (341-445), CHS (446-447)) (122-447)], (223-214')-disulfide with kappa light chain Homo sapiens (1'-214') [V-KAPPA (Homo sapiens IGKV1-33*01 (97.9%) -IGKJ4*01 (100.0%)) [6.3.9] (1'- 107') -Homo sapiens IGKC*01 (100%), Km3 A45.1 (153), V101 (191) (108'-214')]; dimer (223-223":224- 224":227-227":230-230")-tetrakisdisulfide, produced in Chinese Hamster Ovary (CHO) cells, glycoform alfa immunomodulator.
| Anticipated events | Regulatory submission planned in 2025 |
| Factor(s) contributing to discontinuation | None |