Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 2482 |
| INN | Tusamitamab ravtansine |
| Status | Terminated |
| Drug code(s) | SAR408701, IBI126 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | ADC |
| Format, general category | Full length Ab conjugate |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | SPDB (N-succinimidyl 4-(2-pyridyldithio) butyrate linker (stable in plasma and cleavable inside cells)) |
| Ave. DAR | 3.8 |
| Conjugated/fused moiety | Tubulin inhibitor, DM4 maytansine |
| Discovery method/technology | None |
| Target(s) | CEA |
| Indications of clinical studies | Gastric cancer, non-squamous Non-small-cell Lung Cancer , Non-small cell lung cancer, solid tumors |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Terminated at Phase 3 |
| Status | Inactive |
| Start of clinical phase (IND filing or first Phase 1) | August 15, 2014 |
| Start of Phase 2 | |
| Start of Phase 3 | February 06, 2020 |
| 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 | ImmunoGen |
| Licensee/Partner | Sanofi, Innovent |
| Comments about company or candidate | Dec 21, 2023: Sanofi announced that an interim analysis by an independent data monitoring committee found that the ADC did not beat the chemotherapy docetaxel when it came to progression-free survival, missing the study's primary endpoint. As a result, the company is ending its tusamitamab ravtansine program. Phase 3 study for Non-small cell lung cancer (NCT04154956) is recruiting as of last update on May 8, 2023. Aug 5, 2022 - Innovent Biologics Inc said Paris-based Sanofi SA would invest HK$2.42 billion ($307.88 million) in the biopharmaceutical group to jointly develop two cancer drugs in China. SAR408701, or tusamitamab ravtansine, would be used to treat lung, gastric and other cancers, as well as SAR444245, or non-alpha IL-2. NCT04154956 Phase 3 SAR408701 Versus Docetaxel in Previously Treated, Carcinoembryonic Antigen-related Cell Adhesion Molecule 5 (CEACAM5) Positive Metastatic Non-squamous Non-small Cell Lung Cancer Patients (CARMEN-LC03) started in Feb 2020 still recruiting as of last update in May 2022. Feb 2019 update: Achieved positive proof of concept in subgroup of lung cancer patients; a broad development program is expected to start by the end of 2019. (https://www.sanofi.com/-/media/Project/One-Sanofi-Web/Websites/Global/Sanofi-COM/Home/en/investors/docs/press-releases/Q42018results.pdf?la=en&hash=CDCE30350F0C658C000A909535AD9AF636A93560) May 2017: Sanofi granted a fully paid exclusive license to develop, manufacture, and commercialize this candidate. NCT02187848 Phase 1/2 study still recruiting as of Aug 2018 |
| Full address of company | Waltham, Massachusetts, United States North America United States of America https://www.immunogen.com/ |
None
| Anticipated events | None |
| Factor(s) contributing to discontinuation | Lack of efficacy |