MRI RSM01 / Bill & Melinda Gates Foundation - LARVOL DELTA

Establishment of Respiratory Syncytial Virus Microneutralization Assay in Ghana, a Lower-Middle-Income Country (ASTMH 2025) - "Fifty-one whole blood samples from the healthy donor service, are left blank or spiked with 10 or 100 µg/ml palivizumab or RSM01, mAbs against two RSV epitopes. Four researchers in Ghana have been trained on the assay. With the successful implementation of the RSV neutralization assay in dried blood in Ghana, a good foundation has been set for clinical trials and accessible correlate of protection surveillance in children in LMICs."

Respiratory Diseases • Respiratory Syncytial Virus Infections

Genetic variability of respiratory syncytial virus and its impact on monoclonal antibody binding sites: a national cross-sectional study during the 2023-2024 season. (PubMed, Int Immunopharmacol) - "This study provides a critical genomic snapshot of RSV in Italy prior to the introduction of vaccines and mAbs. Continuous surveillance is essential for monitoring viral evolution and supporting the long-term effectiveness of future immunization strategies."

Clinical • Journal • Observational data • Infectious Disease • Influenza • Respiratory Diseases • Respiratory Syncytial Virus Infections

Replacing serum with dried blood microsampling for pharmacokinetics, viral neutralisation and immunogenicity bioanalysis supporting future paediatric development of RSM01, a candidate respiratory syncytial virus neutralising monoclonal antibody. (PubMed, BMC Infect Dis) - P1 | "Both RSM01 concentrations and RSV neutralising activity showed a strong correlation between the serum and blood measurements. ADA measurements also had an agreement of > 90% for individual samples and overall participant status. Our results demonstrate that dried blood is a suitable specimen type for collection and evaluation in the RSM01 clinical development program and shows promise as a useful approach to reduce patient burden in clinical trials, particularly for infants in low- and middle-income countries."

Clinical • Journal • PK/PD data • Pediatrics • Respiratory Diseases • Respiratory Syncytial Virus Infections

RSM01, a novel respiratory syncytial virus monoclonal antibody: preclinical characterization and results of a first-in-human, randomised clinical trial. (PubMed, BMC Infect Dis) - P1 | "RSM01 is a highly potent, half-life-extended, RSV-neutralising mAb candidate that was shown to be well tolerated in healthy adults. The rate of ADA to RSM01 was low. The long half-life of RSM01 and pharmacokinetics profile support further development of RSM01 as a potential single dose per season prophylaxis to prevent RSV disease in infants."

Journal • P1 data • Preclinical • Infectious Disease • Novel Coronavirus Disease • Pain • Pediatrics • Respiratory Diseases • Respiratory Syncytial Virus Infections

RSV Neutralizing Antibodies in Dried Blood. (PubMed, J Infect Dis) - P1 | "We demonstrated the feasibility of measuring RSV neutralization using dried blood as a patient-centered solution that may replace serology testing in trials against RSV or other viruses, such as influenza and SARS-CoV-2. Clinical Trials Registration.  NCT05118386 (ClinicalTrials.gov)."

Journal • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

RSV neutralizing antibodies in dried blood. (PubMed, J Infect Dis) - "We demonstrated the feasibility of measuring RSV neutralization using dried blood as a patient-centered solution that may replace serology testing in trials against RSV or other viruses, such as influenza and SARS-CoV-2."

Journal • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Pharmacokinetics and Safety in Healthy Adults of RSM01, a Novel RSV Monoclonal Antibody, and Population PK Modeling to Support Pediatric Development (IDWeek 2023) - No abstract available

Clinical • PK/PD data • Infectious Disease

Safety, Tolerability, and Pharmacokinetics of RSV Monoclonal Antibody RSM01 in Healthy Adults (clinicaltrials.gov) - P1 | N=56 | Completed | Sponsor: Bill & Melinda Gates Medical Research Institute | Recruiting ➔ Completed | Trial primary completion date: Nov 2022 ➔ Aug 2022

Trial completion • Trial primary completion date • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Safety, Tolerability, and Pharmacokinetics of RSV Monoclonal Antibody RSM01 in Healthy Adults (clinicaltrials.gov) - P1 | N=56 | Recruiting | Sponsor: Bill & Melinda Gates Medical Research Institute | Trial completion date: Oct 2022 ➔ Jan 2023

Trial completion date • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Safety, Tolerability, and Pharmacokinetics of RSV Monoclonal Antibody RSM01 in Healthy Adults (clinicaltrials.gov) - P1 | N=56 | Recruiting | Sponsor: Bill & Melinda Gates Medical Research Institute | Trial primary completion date: May 2022 ➔ Oct 2022

Trial primary completion date • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Safety, Tolerability, and Pharmacokinetics of RSV Monoclonal Antibody RSM01 in Healthy Adults (clinicaltrials.gov) - P1; N=56; Recruiting; Sponsor: Bill & Melinda Gates Medical Research Institute; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections