Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 773 |
| INN | None |
| Status | Clinical |
| Drug code(s) | IBI343 |
| Brand name | None |
| mAb sequence source | mAb human |
| General Molecular Category | ADC |
| Format, general category | Full length Ab conjugate |
| Format details | None |
| Isotype (Fc) | TBD |
| Light chain isotype | TBD |
| Linker | toxSYN® linker-payload |
| Ave. DAR | 4 (Site-specific) |
| Conjugated/fused moiety | Topoisomerase I inhibitor, Exatecan |
| Discovery method/technology | GlycoConnect technology |
| Target(s) | Claudin-18.2 |
| Indications of clinical studies | Gastric/Gastroesophageal Junction Adenocarcinoma, 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) | July 30, 2022 |
| Start of Phase 2 | |
| Start of Phase 3 | June 30, 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 | Innovent Biologics (Suzhou) Co. Ltd. |
| Licensee/Partner | None |
| Comments about company or candidate | June 2024: Food and Drug Administration (FDA) has granted Fast Track Designation to its TOPO1i anti-CLDN18.2 ADC (R&D code: IBI343), for the treatment of advanced unresectable or metastatic pancreatic ductal adenocarcinoma May 6 2024: Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for IBI343 as monotherapy for the treatment of claudin18.2-positive advanced gastric/gastro-esophageal junction adenocarcinoma (GC) patients who have progressed after at least 2 lines of prior systematic treatments. NCT06238843 / CTR20240639 Phase 3 study and NCT06321913 Phase 2 study in Gastric or Gastroesophageal Junction Adenocarcinoma started enrolling by invitation in June 2024. Oct 2022: Company announces first patient dosed. NCT05458219 is a Phase 1a/b, Multicenter, Open-label, First-in-human Study of IBI343 in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors Agreement signed in June 2021 granted Innovent rights to deploy Synaffix’s ADC technologies on a target-specific, non-exclusive basis, including GlycoConnect®, HydraSpace® and one of its toxSYN® linker-payloads, for a therapeutic molecule (Innovent R&D code: IBI343, a CLDN18.2 ADC). |
| Full address of company | Jiangsu, P. R. China 215123 Asia China https://www.innoventbio.com/AboutUs/ContactUs |
IBI343 is a Fully human, it has Silenced Fc, it has been developed using Site-specific glycan conjugation, homogenous DAR4 https://img.innoventbio.com/Innovent-2023-Interiml-Results-Presentation_pipeline-appendix_vf.pdf IBI343 is a potentially first-in-class anti-Claudin 18.2 ADC that is site-specifically glycan-conjugated to cytotoxin exatecan via Synaffix's GlycoConnect® technology. https://www.prnewswire.com/news-releases/innovent-to-present-preclinical-data-of-multiple-novel-molecules-at-the-2024-aacr-annual-meeting-302085392.html; https://doi.org/10.1200/JCO.2024.42.16_suppl.30
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |