Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 612 |
| INN | None |
| Status | Clinical |
| Drug code(s) | ESG401, ESG-401, STI-3258 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | ADC |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | TBD |
| Linker | Undisclosed |
| Ave. DAR | ___ |
| Conjugated/fused moiety | Topoisomerase I inhibitor, SN38 (irinotecan active metabolite) |
| Discovery method/technology | None |
| Target(s) | TROP-2 |
| Indications of clinical studies | Metastatic Breast Cancer, 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) | June 15, 2021 |
| Start of Phase 2 | July 15, 2022 |
| Start of Phase 3 | July 11, 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 | Sorrento Therapeutics Inc. |
| Licensee/Partner | Escugen Biotechnology Co Ltd., Levena (Suzhou) Biopharma Co. Ltd. |
| Comments about company or candidate | NCT06383767 Phase 3 in Metastatic Breast Cancer started in July 2024. NCT04892342 Phase 1/2 started in Sep 2021 recruiting as of last update in Oct 2022. July 21, 2021: Sorrento Therapeutics, Inc. announced its partner Escugen Biotechnology Co, Ltd. (“Escugen”) and Sorrento’s subsidiary Levena (Suzhou) Biopharma Co., Ltd. (“Levena”) have received an approval letter from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for its Application for Clinical Trial (Acceptance No. CXSL2101069) of Recombinant Humanized Anti-Trop2 Mab-SN38 Conjugate. The TROP-2 ADC (ESG-401) was jointly developed by Shanghai-based Escugen and Levena, and the two companies jointly own the domestic and international patents for this ADC and share global rights for the product. Sorrento intends to file a US IND for this ESG-401 before the end of 2021. |
| Full address of company | 9380 Judicial Drive San Diego, CA 92121 North America United States of America https://sorrentotherapeutics.com/contact/ |
Recombinant Humanized Anti-Trop2 Mab-SN38 Conjugate. ESG-401 has potentially distinct differentiating advantages over its competitors in terms of safety, effectiveness and process robustness. Using an innovative, highly stable and cleavable linker, this ADC demonstrated in a series of preclinical studies that it releases very little free toxin during circulation, highly enriches in tumor tissues and rapidly endocytoses, thereby effectively killing tumor cells and inhibiting tumor growth.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |