Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1728 |
| INN | Catumaxomab |
| Status | Regulatory review |
| Drug code(s) | LP000 |
| Brand name | Korjuny, REMOVAB |
| mAb sequence source | mAb murine/rat |
| General Molecular Category | Bispecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG2a/b |
| Light chain isotype | TBD |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Quadroma/hybrid hybridoma (rat/mouse) |
| Target(s) | EPCAM, CD3 |
| Indications of clinical studies | Malignant Ascites Due to Epithelial Carcinoma, ovarian cancer, gastric cancer |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Regulatory review EU |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | July 02, 2001 |
| Start of Phase 2 | |
| Start of Phase 3 | July 02, 2004 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | 2009 |
| Date of first US approval | |
| INN, US product name | Catumaxomab |
| US or EU approved indications | Withdrawn; malignant ascites |
| Company | Trion |
| Licensee/Partner | LintonPharm, Lindis Biotech GmbH, Fresenius |
| Comments about company or candidate | Dec 2022: CHMP meeting: catumaxomab - EMEA/H/C/005697; indicated for the treatment of malignant ascites; Scope: List of questions; Letter by the applicant requesting an extension to the clock stop to respond to the list of questions to be adopted in December 2022. The Committee adopted the CHMP recommendation and scientific discussion together with the list of questions. The CHMP agreed to the request by the applicant for an extension to the clock stop to respond to the list of questions with a specific timetable. EMA started evaluating a marketing application in Aug 2022. NCT04819399 Phase 1 in Urinary Bladder Neoplasms sponsored by Lindis Biotech GmbH started recruiting patients in July 2020. NCT04799847 Phase 1/2 in bladder cancer due to start in July 2021. July 2020: LintonPharm announced the China National Medical Products Administration (NMPA) authorized the company to proceed with a Phase III trial for catumaxomab in patients with peritoneal carcinomatosis, a form of advanced gastric cancer that has spread to the tissue that lines the abdominal cavity. LintonPharm also recently received Clinical Trial Application (CTA) authorization for the same indication from the Taiwan Ministry of Health and Welfare (MOHW) and the Korea Ministry of Food and Drug Safety (MFDS). Withdrawn from EU market in June 2017 Marketing authorization granted on April 20, 2009; withdrawn June 2, 2017 at the request of authorization holder Neovil Biotech GmbH. Decision to permanently discontinue marketing was due to commercial reasons. The product had not been marketed in the EU since 2014. |
| Full address of company | Trion Research GmbH, Zeppelinstraße 4, 82178 Puchheim Europe Germany https://www.trionresearch.com/contact/ |
IgG2a (mouse), IgG2b (rat)
| Anticipated events | Regulatory review EU - positive opinion in Oct 2024, anticipate approval |
| Factor(s) contributing to discontinuation | Commercial/business decision |