Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 2076 |
| INN | Andecaliximab |
| Status | Clinical |
| Drug code(s) | GS-5745 |
| 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) | MMP9 |
| Indications of clinical studies | Fibrodysplasia ossificans progressiva, Gastric Adenocarcinoma, Rheumatoid arthritis, chronic obstructive pulmonary disorders, ulcerative colitis, Solid tumors |
| Primary therapeutic area | Skeletal disorders |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | March 15, 2013 |
| Start of Phase 2 | April 15, 2015 |
| Start of Phase 3 | September 18, 2015 |
| 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 | Gilead Sciences Inc |
| Licensee/Partner | āshibio |
| Comments about company or candidate | NCT06508021 Phase 2/3 in Fibrodysplasia Ossificans Progressiva started in Nov 2024. āshibio plans to initiate a Phase 2/3 trial of andecaliximab in the second half of 2024 in patients with FOP. The U.S. Food and Drug Administration (FDA) designated andecaliximab an Orphan Drug for the treatment of FOP in March 2024, one month after the European Medicines Agency (EMA) issued its own Orphan Drug Designation for the therapy. The FDA also cleared āshibio’s Investigational New Drug (IND) application for andecaliximab in March 2024. https://ashibio.com/ashibio-raises-40m-in-seed-and-series-a-financing-to-advance-therapies-for-bone-and-connective-tissue-disorders/ NCT02545504 Phase 3 study in Gastric Adenocarcinoma started in Oct 2015 competed in April 2019. Not listed in Q3 2018 Gilead results slides dated Oct 25, 2019, although the asset is listed in the Q2 2018 slides. Listed in Gilead pipeline as of Sep 2018. As of Aug 2017, Gilead lists asset as in studies for gastric cancer and solid tumors only. Sep. 21, 2016-- Gilead Sciences, Inc. announced that the company is stopping its combined Phase 2/3 clinical study (NCT02520284) of GS-5745, an investigational anti-MMP9 antibody, among patients with moderately to severely active ulcerative colitis. This decision follows a planned interim analysis of unblinded efficacy and safety data by the Data Monitoring Committee (DMC) after the first 150 patients of a planned 1600-patient trial were treated for an 8-week induction duration. The DMC recommended that the study be terminated early due to meeting the pre-specified futility and efficacy criteria. a Phase 3 study of GS-5745 is ongoing in patients with gastric cancer, as well as a Phase 2 study in patients with gastric cancer in combination with nivolumab and additional Phase 2 studies in moderately to severely active Crohn’s disease, rheumatoid arthritis and cystic fibrosis. These studies will continue as planned. NCT02545504 Phase 3 study in Advanced Gastric or Gastroesophageal Junction Adenocarcinoma recruiting as of Nov 2015. NCT02520284 Phase 2/3 study in Moderately to Severely Active Ulcerative Colitis recruiting as of Sep 18, 2015. Phase 1 NCT01803282 (solid tumors); NCT01831427 (ulcerative colitis). NCT02759562 Phase 2 study in cystic fibrosis terminated. |
| Full address of company | 333 Lakeside Drive Foster City, CA 94404 North America United States of America https://www.gilead.com/our-company/us-locations |
Humanized by Antitope's Composite Human Antibody Technology
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |