Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 876 |
| INN | None |
| Status | Clinical |
| Drug code(s) | JSKN003, JSKN033 (combo of JSKN003 and envafolimab) |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | ADC, Bispecific, Biparatopic |
| Format, general category | Full length Ab conjugate |
| Format details | None |
| Isotype (Fc) | TBD |
| Light chain isotype | TBD |
| Linker | None |
| Ave. DAR | 3 to 4 |
| Conjugated/fused moiety | Topoisomerase I inhibitor |
| Discovery method/technology | None |
| Target(s) | HER2, HER2 |
| Indications of clinical studies | 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) | May 15, 2022 |
| Start of Phase 2 | |
| Start of Phase 3 | November 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 | Alphamab (Australia) Co Pty Ltd. |
| Licensee/Partner | CSPC Pharmaceutical Group Co., Ltd. |
| Comments about company or candidate | Sep 2024: Alphamab Oncology announced that Jiangsu Alphamab Biopharmaceuticals Co., Ltd., a wholly-owned subsidiary of Alphamab Oncology, entered into a licensing agreement on anti-HER2 bispecific antibody-drug conjugate JSKN003 with JMT-Bio Technology Co., Ltd., a wholly-owned subsidiary of CSPC Pharmaceutical Group Co., Ltd. According to the terms of the Licensing Agreement, JMT-Bio will obtain the exclusive license and sublicense rights to develop, sell, offer for sale and commercialize JSKN003, for the treatment of tumor-related indications in mainland China (excluding Hong Kong, Macau or Taiwan) (the "Territory") and become the sole marketing authorization holder for JSKN003 for the Field in the Territory. Phase III clinical study JSKN003-302 is NCT06079983. Dec. 4, 2023: Alphamab Oncology announced the first patient has been dosed in the phase III clinical study (JSKN003-302) of anti-HER2 bispecific antibody-drug conjugate JSKN003 for treatment of advanced HER2-low breast cancer. https://www.prnewswire.com/apac/news-releases/first-patient-dosed-in-phase--study-of-jskn003-for-the-treatment-of-advanced-her2-low-breast-cancer-302004249.html NCT05744427 and NCT06226766 are Phase 1/2 studies in solid tumors. JSKN033 is a combination drug product comprised of JSKN003 and envafolimab for subcutaneous injection. NCT05744427 Phase 1 started in March 2023; Mar 16: Alphamab Oncology announced that the first patient has been dosed with 2.1mg/kg in a Phase I clinical study (JSKN003-102) of JSKN003, an Anti-HER2 bispecific ADC. NCT05494918 Phase 1 started in Aug 2022; company announced Sep 19, 2022 that the first patient has been successfully dosed in a phase I clinical trial of JSKN003 (a KN026 (a recombinant humanized anti-human epidermal growth factor receptor 2 (“HER2”) bispecific antibody) antibody-drug conjugate (“KN026-ADC”) independently developed by the Company) in Australia, and that in August 2022, the investigational new drug (“IND”) application of JSKN003 was submitted to the National Medical Products Administration of China (the “NMPA”) and accepted for the treatment of solid tumors. The Company completed the efficacy validation and process development for JSKN-003 in June 2021 and targets to submit IND application in the second quarter of 2022. In May 2021, Jiangsu Alphamab entered into a collaboration agreement with Suzhou Alphamab Co., Ltd. for two technology development projects, namely, JSKN003 and the preparation process development project for mGalt1, a key material of conjugation process. |
| Full address of company | 218 Xinhu St. Building #C23, Suzhou, Jiangsu Asia China https://www.alphamabonc.com/en/contact/index.html |
JSKN003 is an anti-HER2 bispecific antibody-drug conjugate (bis-ADC), developed inhouse with proprietary Glycan-specific conjugation platform; targets domain II and IV of HER2 (https://www.alphamabonc.com/en/uploads/2021/01/210003484816.pdf). See also https://www.alphamabonc.com/en/uploads/2023/08/169286574293454.pdf. JSKN003 and anti-PD-1 envafolimab combination = JSKN033
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |