rimteravimab (XVR011) / ExeVir Bio - LARVOL DELTA

Characterization of the VHH-Fc construct rimteravimab in healthy adults and patients hospitalized for mild-to-moderate COVID-19: Two Phase 1 randomized clinical trials. (PubMed, PLoS Med) - P1/2 | "XVR011 displayed a favourable safety, tolerability, pharmacokinetics, and immunogenicity profile, both in healthy volunteers and in patients hospitalized for mild to moderate COVID-19. These data pave the way for the design and clinical development of VHH-Fc constructs."

Clinical • Journal • P1 data • Infectious Disease • Novel Coronavirus Disease • Pain • Respiratory Diseases

Dose-Finding, Safety, and Efficacy Study of XVR011 Added to Standard of Care in Patients Hospitalised for COVID-19 (clinicaltrials.gov) - P1/2 | N=27 | Terminated | Sponsor: ExeVir Bio BV | This early end of trial is not due to reasons of safety or lack of efficacy. Part 1 (Phase 1) is completed as per protocol.

Enrollment change • Trial termination • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Dose-Finding, Safety, and Efficacy Study of XVR011 Added to Standard of Care in Patients Hospitalised for COVID-19 (clinicaltrials.gov) - P1/2; N=279; Recruiting; Sponsor: ExeVir Bio BV; Trial completion date: Sep 2021 ➔ Jun 2022; Trial primary completion date: Sep 2021 ➔ Apr 2022

Clinical • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Dose-Finding, Safety, and Efficacy Study of XVR011 Added to Standard of Care in Patients Hospitalised for COVID-19 (clinicaltrials.gov) - P1/2; N=279; Recruiting; Sponsor: ExeVir Bio BV; Initiation date: May 2021 ➔ Aug 2021

Clinical • Trial initiation date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

ExeVir's COVID-19 antibody candidate neutralizes coronavirus Variants of Concern (PRNewswire) - "ExeVir...has generated data on its COVID-19 antibody XVR011 which demonstrate in vitro neutralization activity against SARS-CoV-2 Variants of Concern Gamma and Delta. The company has also obtained grant funding of €3 million from the Flanders Agency for Innovation & Entrepreneurship (VLAIO) to accelerate clinical development of lead asset, the unique llama-derived VHH72-Fc antibody XVR011....XVR011 demonstrated strong in vitro neutralization potency against the Variants of Concern Delta (B.1.617.2) and Gamma (P.1). Previously, data was generated showing neutralising potency against Alpha (B.1.1.7) and Beta (B.1.351) VOCs."

Preclinical • Infectious Disease • Novel Coronavirus Disease

Dose-Finding, Safety, and Efficacy Study of XVR011 Added to Standard of Care in Patients Hospitalised for COVID-19 (clinicaltrials.gov) - P1/2; N=279; Recruiting; Sponsor: ExeVir Bio BV

Clinical • New P1/2 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Dose-Finding, Safety, and Efficacy Study of XVR011 Added to Standard of Care in Patients Hospitalised for COVID-19 (clinicaltrialsregister.eu) - P1/2; N=279; Ongoing; Sponsor: ExeVir Bio

Clinical • New P1/2 trial • Infectious Disease • Novel Coronavirus Disease