Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 185 |
| INN | Domvanalimab |
| Status | Clinical |
| Drug code(s) | AB154 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| 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 | Gastrointestinal Tract Malignancies, Melanoma, Non-small Cell Lung Cancer, Advanced malignancies |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | August 07, 2018 |
| Start of Phase 2 | January 13, 2020 |
| Start of Phase 3 | February 01, 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 | Arcus Biosciences Inc. |
| Licensee/Partner | Gilead Sciences, Taiho Pharma |
| Comments about company or candidate | NCT05211895 Phase 3 study still recruiting as of last update in Oct 2024. Phase 3 studies for Gastrointestinal tract adenocarcinoma (NCT05568095); Non-small cell lung cancer (NCT05211895, NCT05502237, NCT04736173) are recruiting as of April-May 2023. NCT05568095 Phase 3 in GI cancer due to start in Oct 2022 Aug 2022 presentation: ARC-7 topline data (2H), presentation (2023); no mention of submission timeline Taiho Pharma has Option rights exercised for majority of Arcus’s clinical-stage portfolio— domvanalimab, zimberelimab, etrumadenant, and AB308 NCT04736173 is a Phase 3 Study to Evaluate Zimberelimab (AB122) Monotherapy Compared to Standard Chemotherapy or Zimberelimab Combined With AB154 in Front-Line, PD-L1-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer October 29, 2020 I Arcus Biosciences, Inc. (NYSE:RCUS), an oncology-focused biopharmaceutical company working to create best-in-class cancer therapies, today announced a collaboration with AstraZeneca (LSE/STO/Nasdaq: AZN) to evaluate domvanalimab (AB154), Arcus’s investigational anti-TIGIT antibody, in combination with Imfinzi (durvalumab) in a registrational Phase 3 clinical trial in patients with unresectable Stage III non-small cell lung cancer (NSCLC). A Registrational Trial for Domvanalimab plus Imfinzi is Expected to Begin in 2021 Feb 2020: Arcus Biosciences, Inc. and Taiho Pharmaceutical Co. Ltd. announced Taiho’s exercise of its option to exclusively license zimberelimab, an anti-PD-1 monoclonal antibody, from Arcus Biosciences for commercialization in Japan and certain other territories in Asia (excluding China). NCT04262856 is a Phase 2 Study to Evaluate the Safety and Efficacy of AB122 Monotherapy, AB154 in Combination With AB122, and AB154 in Combination With AB122 and AB928 in Front-Line, Non-Small Cell Lung Cancer started in Jan 2020. NCT03628677 Phase 1 started in Aug 2018 still recruiting as of Aug 2019. In September 2016, Arcus Biosciences, Inc raised an additional USD 70 million in equity capital from Taiho Ventures, GV, Invus, DROIA Oncology Ventures and Stanford University, together with its Series A investors, including The Column Group, Foresite Capital, Novartis and Celgene. This funding allows Arcus to continue its rapid drug development activities for the small molecule and antibody immuno-oncology approaches with the goal of building its own internal combinations. IND filing planned for mid-2018. |
| Full address of company | California, United States North America United States of America https://arcusbio.com/ |
Immune checkpoint target. AB154 is a fully humanized, Fc silent antibody that blocks human TIGIT with sub-nanomolar affinity, as determined using a CHO.hTIGIT over-expressing cell line and primary human T-cells. https://cancerimmunolres.aacrjournals.org/content/7/2_Supplement/A124
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |