Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1243 |
| INN | Amlitelimab |
| Status | Clinical |
| Drug code(s) | SAR445229, KY1005 |
| Brand name | None |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG4 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Transgenic mouse (Kymouse technology) |
| Target(s) | OX40L |
| Indications of clinical studies | Celiac Disease, Alopecia Areata, Hidradenitis, Asthma, Eczema, Atopic dermatitis |
| 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) | May 29, 2017 |
| Start of Phase 2 | December 13, 2018 |
| Start of Phase 3 | August 22, 2022 |
| 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 | Sanofi |
| Licensee/Partner | None |
| Comments about company or candidate | NCT06557772 Phase 2 in celiac disease due to start in Aug 2024. NCT06444451 Phase 2 in Alopecia Areata due to start in June 2024 NCT06181435 Phase 3 study in atopic dermatitis due to start in Dec 2023. NCT06130566 Phase 3 study in atopic dermatitis started in Nov 2023. NCT06118099 Phase 2 study in Hidradenitis due to start in Nov 2023. Included in Q4 2022 pipeline update; NCT05769777 Phase 2 to start in Mar 2023. NCT05492578 Phase 2/3 in atopic dermatitis study started in Aug 22, 2022. April 2021: Sanofi announced the successful completion of its acquisition of Kymab Group Ltd. Aug 2020: Early Phase 2 data demonstrate that KY1005 has the potential to be a therapeutic option for chronic inflammatory diseases such as atopic dermatitis. NCT04449939 is a Phase I, Open-label Study to Assess the Pharmacokinetics of KY1005 After Single Dose Administration by Subcutaneous and Intravenous Route in Healthy Volunteers. NCT03754309 Phase 2a, Randomized, Double Blind, Placebo Controlled, Parallel Group, Multicentre Study of an Anti OX40L Monoclonal Antibody (KY1005) in Moderate to Severe Atopic Dermatitis started in Dec 2018. 30 July 2018: Kymab, a clinical-stage biopharmaceutical company developing fully human monoclonal antibody therapeutics, announces today that it has obtained positive data in its Phase I trial of KY1005 and will proceed to Phase II studies in atopic dermatitis, with additional plans to run studies in other immune-mediated diseases, such as Graft-versus-Host Disease (GvHD). Phase 1 NCT03161288 study competed in March 2018. KY1005 has already shown outstanding preclinical results in a project led by Dr Leslie Kean, Associate Director of the Ben Towne Center for Childhood Cancer Research at Seattle Children’s Research Institute, published in a poster presentation at the American Society of Hematology Annual Meeting in San Diego in 2016 |
| Full address of company | Paris, France Europe France https://www.sanofi.us/en/contact-us |
Immune checkpoint modulator. KY1005, a fully human monoclonal antibody, is a potential first-in-class therapeutic that may address an underlying immune system imbalance in patients with many autoimmune conditions. It binds to OX40L and blocks it from activating OX40, a protein that induces a prolonged response in T-cells, which can lead to diseases of the immune system and damaging effects on patients.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |