Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 718 |
| INN | None |
| Status | Clinical |
| Drug code(s) | HLX22, AC-101 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | TBD |
| Format, general category | TBD |
| Format details | TBD |
| Isotype (Fc) | TBD |
| Light chain isotype | TBD |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | HER2 |
| Indications of clinical studies | Gastric 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) | November 15, 2018 |
| Start of Phase 2 | October 15, 2021 |
| Start of Phase 3 | November 22, 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 | Alligator Bioscience AB |
| Licensee/Partner | Shanghai Henlius Biotech Co. Ltd., AbClon Inc. |
| Comments about company or candidate | Nov 22, 2024: The First Patient Has Been Dosed in Phase 3 Clinical Study of HLX22 NCT06532006 / CTR20243366 Phase 3 in gastric cancer due to start in Nov 2024. May 6, 2024: Application for the Phase 3 clinical trial of HLX22 (anti-human epidermal growth factor receptor-2 (HER2) humanized monoclonal antibody injection) in combination with Trastuzumab and chemotherapy as the first-line treatment of HER2 positive advanced gastric cancer has been approved by the United States Food and Drug Administration. October 20, 2021: Alligator Bioscience AB announced that the Company was notified that the first patient has been dosed in its Phase II clinical trial collaboration with Shanghai Henlius Biotech, Inc. and AbClon, Inc. NCT04908813 Phase 2 in gastric cancer started start in Sep 2021 still recruiting as of last update in April 2022. NCT03916094 Phase 1 study started in July 2019. Henlius has recently received an investigational new drug (IND) application acceptance notification from the National Medical Products Administration (NMPA) for its HLX22, a monoclonal antibody injection, for the treatment of gastric cancer (GC) and breast cancer (BC). HLX22 is a humanized lgG1 monoclonal antibody injection targeting human epidermal growth factor receptor 2 (HER2). Henlius introduced HLX22 from AbClon, Inc. (AbClon) and researched and developed it independently as follows. Since 2016, Henlius successively signed license agreement and amendment agreement with AbClon, being granted exclusive rights to develop and commercialize HLX22 globally. With the good performance in pre-clinical stage, HLX22 is expected not only to be used as mono-therapy in the treatment of GC and BC, but also in combination with HLX02 (a trastuzumab biosimilar developed by Henlius), making it a potentially first-in-class combination therapy in GC in the world. Looking forward, Henlius will continue to promote the implementation of the globalization strategy to achieve the vision of providing all patients with high-quality and affordable protein therapeutics. Alligator out-licensed AC101 to AbClon, Inc. in October 2016. Abclon, Inc. subsequently sub-licensed AC101 in China for clinical development by Shanghai Henlius Biotech Inc. |
| Full address of company | Medicon Village, Scheelevägen 2, SE-223 81 Lund Sweden Europe Sweden https://alligatorbioscience.se/en/ |
HLX22 can bind to HER2 subdomain IV at a binding site different from that of trastuzumab, which allows simultaneous binding of HLX22 and trastuzumab to HER2 dimers (HER2 homodimer and HER2/EGFR heterodimer) on tumour cell surface, thereby promoting the internalisation and HER2 dimer degradation. doi:10.1007/s10637-023-01338-7
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |