Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 567 |
| INN | None |
| Status | Clinical |
| Drug code(s) | DP303c |
| 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 | Cleavable linker |
| Ave. DAR | 2 (Site-specific) |
| Conjugated/fused moiety | Tubulin inhibitor, Monomethyl auristatin E (MMAE) |
| Discovery method/technology | None |
| Target(s) | HER2 |
| Indications of clinical studies | HER2-positive Breast Cancer, gastric cancer with HER2 expression, advanced 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) | November 15, 2019 |
| Start of Phase 2 | June 15, 2021 |
| Start of Phase 3 | November 08, 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 | CSPC Pharmaceutical Group Limited |
| Licensee/Partner | None |
| Comments about company or candidate | NCT06313086 Phase 3 due to start in Mar 2024. Aug 2023: Launch in breast cancer anticipated in 2025 (https://www.cspc.com.hk/en/ir/presentations/20231H.pdf) NCT05901935/CTR20231487 Phase 3 in breast cancer started in Nov 2023. Listed as Phase 2/3 pivotal on CSPC Pharmaceutical group Limited 2023 1Q Results presentation (May 2023) https://www.cspc.com.hk/en/ir/presentations/20231Q.pdf CTR20230784 not yet recruiting NCT05334810 Phase 2 in breast cancer due to start May 1 2022. NCT04828616 Phase 2 in ovarian cancer due to start in July 2021. CTR20210829 Phase 2 in gastric cancer, first subject enrolled in June 2021; NCT04826107 Phase 2 in gastric cancer due to start in August 2021. Phase 2 NCT04146610 Phase 1 in solid tumors not yet recruiting when posted on Oct 31, 2019. US orphan drug designation for treating stomach cancer, including gastroesophageal junction tumor. |
| Full address of company | No.226 Huanghe Street, Shijiazhuang, Hebei Province, PRC 050035 Asia China https://www.cspc.com.hk/en/contacts/contactus.php |
DP303c consists of an antibody that selectively binds to HER2 and a cytotoxic agent, representing a new type of targeted drug for the treatment of HER2 positive gastric cancer. DP303c has shown potent anti-tumor effects in a mouse NCI-N87 model for HER2 positive human gastric cancer and in an in-vitro assay with HER2 positive SK-BR-3 cell line. We developed DP303c, a novel HER2-targeting ADC made up of a humanized anti-HER2 antibody (DP001), an enzyme-based cleavable peptide-linker, and two tubulin polymerization inhibitors (MMAE), using our original conjugation and linker-payload technique. The materials used for DP303c production included anti-HER2 mAb (DP001), linker-MMAE (LND1002) and mTgase. DP001 was manufactured using a stable Chinese Hamster Ovary (CHO) cell line by ourselves. The amino acid sequence of DP001 was the same with that of Herceptin. Onco Targets Ther. 2022; 15: 331–343. doi: 10.2147/OTT.S357326
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |