Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1015 |
| INN | Clesrovimab |
| Status | Regulatory review |
| Drug code(s) | MK-1654 |
| Brand name | None |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | RSV (F glycoprotein) |
| Indications of clinical studies | RSV infection |
| Primary therapeutic area | Infectious diseases |
| Most advanced stage of development (global) | Regulatory review EU |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | August 30, 2018 |
| Start of Phase 2 | October 28, 2019 |
| Start of Phase 3 | April 07, 2021 |
| 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 | Merck |
| Licensee/Partner | None |
| Comments about company or candidate | EMA starts Clesrovimab MAA evaluation on Nov 28, 2024. July 2024: Merck announced positive topline results from its Phase 2b/3 clinical trial (MK-1654-004) evaluating clesrovimab (MK-1654), the company’s investigational prophylactic monoclonal antibody designed to protect infants from respiratory syncytial virus (RSV) disease. Regulatory submissions are planned. https://www.businesswire.com/news/home/20240723229019/en/Merck-Announces-Topline-Results-from-Phase-2b3-Trial-of-Clesrovimab-MK-1654-an-Investigational-Respiratory-Syncytial-Virus-Preventative-Monoclonal-Antibody-for-Infants Phase 2/3 (NCT04767373) and Phase 3 (NCT04938830) studies for Reduction in incidence of respiratory syncytial virus infection are recruiting as of May 26, 2023 Listed as Phase 3 asset in Merck pipeline dated Feb 2023. NCT04938830 Phase 3 study started in Nov 2021. NCT04767373 Phase 2/3 study in Healthy Pre-Term and Full-Term Infants started in April 2021. NCT04086472 Phase 2 study started in Oct 2019. NCT03524118, which changed to Phase 1/2 at some point, is still recruiting as of last record update in Aug 2019. Phase 1 NCT03524118 is A Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK-1654 in Pre-Term and Full-Term Infants started in Sep 2018. In a Phase 1 study, MK-1654 was generally well tolerated at doses up to 300 mg IM and up to 3000 mg IV and resulted in a dose dependent increase in SNA titers, reflecting biologically active MK-1654 in the serum. No treatment emergent ADAs have been observed. (https://idsa.confex.com/idsa/2018/webprogram/Paper71974.html) |
| Full address of company | Rahway, NJ 07065 USA North America United States of America https://www.merck.com/contact-us/ |
MK-1654 is a fully human monoclonal antibody targeting the RSV fusion (F) protein with Fc domain mutations to extend half-life that is being developed to provide passive immunity against RSV in infants. Incorporation of YTE mutations extend its half-life to allow for dosing once every RSV season. Preferentially targets the prefusion F protein over the postfusion one, according to https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6742648/
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |