Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1162 |
| INN | None |
| Status | Clinical |
| Drug code(s) | QX005N, SNC005 |
| Brand name | None |
| mAb sequence source | mAb - source TBD |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | TBD |
| Light chain isotype | TBD |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Rabbit derived |
| Target(s) | IL-4R alpha |
| Indications of clinical studies | Chronic sinusitis with nasal polyps, nodular prurigo, atopic dermatitis, Phase 1 in healthy volunteers |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | July 15, 2020 |
| Start of Phase 2 | September 15, 2022 |
| Start of Phase 3 | May 10, 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 | Jiangsu Qyuns Therapeutics Co. Ltd. |
| Licensee/Partner | None |
| Comments about company or candidate | CTR20241660 Phase 3 in nodular prurigo not yet recruiting as of May 31, 2024. CTR20241068 Phase 3 in atopic dermatitis started in May 2024 CTR20221723 Phase 2 in atopic dermatitis has test status "in progress"; first subject enrolled in Sep 2022. As of Dec 2022, Palisades Bio does not appear to be developing this asset. On June 5 2021, Quanxin QX005N Injection Phase Ib Program Discussion Meeting was successfully held in Beijing. The trial is a randomized, double-blind, placebo-controlled, multicenter study of efficacy, safety, pharmacokinetics and pharmacodynamics in adult subjects with moderate to severe atopic dermatitis. The meeting conducted in-depth discussions on the phase Ib clinical program. April 26, 2021: Seneca Biopharma, Inc. disclosed on April 23, 2021, the passing of the final proposal required for approval of the proposed merger between Seneca and Leading Biosciences, Inc. ("LBS"). The Merger is expected to close on or about April 27, 2021 and the new combined company, Palisades Bio, is expected to begin trading on the Nasdaq Capital Market on or about April 28, 2021 under the ticker "PALI". CTR20201779 Phase 1 started in Nov 2020. July 2020: Jiangsu Qyuns Therapeutics Co.,Ltd registered a Phase I, single-center, randomized, double-blind, placebo-controlled, single-dose incremental study for the safety, tolerability, pharmacokinetics and immunogenicity of healthy volunteers. The trial was registered with the China clinical trial registry. Seneca Biopharma Inc and Jiangsu QYuns Therapeutics Co Ltd jointly announced that they have entered into a non-binding term sheet for the licensing of certain assets owned by QYuns. Seneca and QYuns will enter into a royalty- and milestone-free, perpetual, non-cancelable, exclusive worldwide, other than in Greater China (which includes Hong Kong, Macau and Taiwan and certain other Asian territories) license to develop and commercialize certain of QYuns' assets, including QX005N, targeting IL-4Rα, QX002N, targeting IL-17A, QX004N targeting IL-23A, and QX006N targeting IFNRα. Seneca will also gain access to future antibody assets developed by QYuns and the parties will collaborate on future pipeline expansion. Upon entering into the license, Seneca's lead asset will be SNC005 (QX005N) that targets IL-4Rα for the treatment of asthma and atopic dermatitis. As consideration for the license, Seneca will issue QYuns a yet to be determined amount of common stock. https://senecabio.com/news-media/presentations/2019-11-01_Seneca_Presentation.pdf |
| Full address of company | No.907 Yaocheng Avenue, Taizhou, Jiangsu, China Asia China https://www.qyuns.net/en/ |
None
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |