Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 787 |
| INN | Caxmotabart entudotin |
| Status | Clinical |
| Drug code(s) | IKS014, LCB14-0110, FS-1502 |
| 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 | β-glucuronidase (BG; Cleavable linker |
| Ave. DAR | 2 (Site-specific) |
| Conjugated/fused moiety | Tubulin inhibitor, Monomethyl auristatin F (MMAF) |
| Discovery method/technology | None |
| Target(s) | HER2 |
| Indications of clinical studies | Breast Cancer |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | January 01, 2019 |
| Start of Phase 2 | July 01, 2022 |
| Start of Phase 3 | March 15, 2023 |
| 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 | LegoChem Biosciences Inc. |
| Licensee/Partner | IKSUDA Therapeutics, Shanghai Fosun Pharmaceutical Development Co Ltd. |
| Comments about company or candidate | CTR20230426 multicenter, open-label, randomized controlled phase III clinical study: comparing the efficacy and safety of FS-1502 and T-DM1 in patients with HER2-positive unresectable locally advanced or metastatic breast cancer; first patient dosed Mar 28, 2023. June 2023: Listed as Phase 3 in Lego pipeline, with Fosun as partner, but listed as Phase 2 in Fosun pipeline; accessed June 18, 2023. NCT05755048 Phase 3 in breast cancer due to start in March 2023 Dec 2022: Listed as Phase 2 in company pipeline 10 January 2022: Iksuda Therapeutics announced further expansion of its differentiated ADC pipeline through a license and commercialisation agreement with LegoChem Biosciences (LCB), a Korean biopharmaceutical company focused on the development of next-generation novel therapeutics utilising its proprietary medicinal drug discovery technologies. The agreement provides Iksuda with exclusive world-wide rights (excluding Greater China and South Korea) to LCB’s Her2 ADC programme, LCB14. The agreement includes development, regulatory and commercial milestone payments to LCB contingent on successful achievement of certain milestones as well as royalties on commercial sales. NCT03944499 Phase 1 last update done in May 2019. Phase 1 according to LegoChem website pipeline accessed April 2, 2019 |
| Full address of company | 10, Gukjegwahak 10-ro, Yuseong-gu, Daejeon, Republic of Korea Asia Republic of Korea https://www.legochembio.com/company/location.php?lang=e |
FS-1502 is a site-specific HER-2 targeting ADC developed by Fosun Pharma utilizing LegoChem Biosciences’ proprietary ADC platform technology ConjuAll™. MMAF, from the auristatin family, is used as the payload. immunoglobulin G1-kappa, anti-[Homo sapiens ERBB2 (receptor tyrosine-protein kinase erbB-2, epidermal growth factor receptor 2, EGFR2, HER2, HER-2, p185c-erbB2, NEU, CD340)], humanized monoclonal antibody, conjugated on an average of two cysteinyl residues to entudotin;
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |