Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 551 |
| INN | Trastuzumab pamirtecan |
| Status | Clinical |
| Drug code(s) | DB-1303, BNT323 |
| 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 | TBD |
| Linker | Enzymatically cleavable peptide linker |
| Ave. DAR | ___ |
| Conjugated/fused moiety | Topoisomerase I inhibitor, P1003 |
| Discovery method/technology | None |
| Target(s) | HER2 |
| Indications of clinical studies | Endometrial cancer, 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) | December 15, 2021 |
| Start of Phase 2 | |
| Start of Phase 3 | December 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 | Duality Biologics (Suzhou) Co. Ltd. |
| Licensee/Partner | BioNTech SE |
| Comments about company or candidate | NCT06340568 Phase 3 in endometrial cancer due to start in November 2024. NCT06265428 Phase 3 in breast cancer started in Jan 2024. Jan 22, 2023: BioNTech SE and Duality Biologics announced that the first patient with metastatic breast cancer has been treated in a pivotal Phase 3 trial evaluating the efficacy and safety of BNT323/DB-1303, 'NCT06018337 Phase 3 in breast cancer started in Nov 2023. Jan 2023: Duality Biologics has announced that the U.S. Food and Drug Administration granted Fast Track Designation to the antibody-drug conjugate DB-1303 for the treatment of patients with advanced, recurrent or metastatic endometrial carcinoma with HER2 overexpression who have progressed on or after standard systemic treatment. NCT05150691 Phase 1 started in Jan 2022; the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of DB-1303 will be assessed in patients with advanced/metastatic solid tumors. |
| Full address of company | Unit 1105-1106, #868 Yinghua Road, Pudong New District, Shanghai, China Asia China https://dualitybiologics.com/ |
DB-1303 is composed of an anti-HER2 monoclonal antibody, enzymatically cleavable peptide-linker, and a proprietary topoisomerase I inhibitor P1003. https://ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.3023
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |