XAV-19 / LFB SA, Xenothera - LARVOL DELTA

Anti-SARS-CoV-2 glyco-humanized polyclonal antibody XAV-19: phase II/III randomized placebo-controlled trial shows acceleration to recovery for mild to moderate patients with COVID-19. (PubMed, Front Immunol) - P2/3 | "Altogether, these data support a possible therapeutic interest for patients with mild to moderate COVID-19 requiring anti-SARS-CoV-2 neutralizing antibodies. https://clinicaltrials.gov/, identifier NCT04928430; https://www.clinicaltrialsregister.eu/about.html (EudraCT), identifier 2020-005979-12."

Clinical • Journal • P2 data • P2/3 data • P3 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Effect of Swine Glyco-humanized Polyclonal Neutralizing Antibody on Survival and Respiratory Failure in Patients Hospitalized With Severe COVID-19: A Randomized, Placebo-Controlled Trial. (PubMed, Open Forum Infect Dis) - "In the safety population, adverse events were reported in 75.4% of 199 patients in the XAV-19 group and in 76.3% of 190 patients in the placebo group through D29. Among patients hospitalized with COVID-19 requiring low-flow oxygen therapy, treatment with a single intravenous dose of XAV-19, compared with placebo, did not show a significant difference in terms of disease progression at day 15."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

XAV-19, un anti-variant de Sars-CoV-2, BQ.1.1 compris. (PubMed, Rev Francoph Lab) - No abstract available

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

EUROXAV: Efficacy and Safety of XAV-19 for the Treatment of Moderate-to-severe COVID-19 (clinicaltrials.gov) - P2/3 | N=290 | Terminated | Sponsor: Xenothera SAS | N=722 ➔ 290 | Trial completion date: Apr 2022 ➔ Nov 2022 | Recruiting ➔ Terminated | Trial primary completion date: Apr 2022 ➔ Nov 2022; Lack of recruitment

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Infectious Disease • Novel Coronavirus Disease

POLYCOR: Study to Evaluate the Safety and Efficacy of XAV-19 in Patients With COVID-19 Induced Moderate Pneumonia (clinicaltrials.gov) - P2 | N=416 | Completed | Sponsor: Nantes University Hospital | Active, not recruiting ➔ Completed | Trial completion date: Dec 2021 ➔ Aug 2021 | Trial primary completion date: Dec 2021 ➔ May 2021

Trial completion • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Pneumonia

XAV-19, a Swine Glyco-Humanized Polyclonal Antibody Against SARS-CoV-2 Spike Receptor-Binding Domain, Targets Multiple Epitopes and Broadly Neutralizes Variants. (PubMed, Front Immunol) - P2, P2/3 | "XAV-19 is currently evaluated in patients hospitalized for COVID-19-induced moderate pneumonia in phase 2a-2b (NCT04453384) where safety was already demonstrated and in an ongoing 2/3 trial (NCT04928430) to evaluate the efficacy and safety of XAV-19 in patients with moderate-to-severe COVID-19. Owing to its polyclonal nature and its glyco-humanization, XAV-19 may provide a novel safe and effective therapeutic tool to mitigate the severity of coronavirus disease 2019 (COVID-19) including the different variants of concern identified so far."

Journal • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

EUROXAV: Efficacy and Safety of XAV-19 for the Treatment of Moderate-to-severe COVID-19 (clinicaltrials.gov) - P2/3; N=722; Recruiting; Sponsor: Xenothera SAS; Trial completion date: Aug 2021 ➔ Apr 2022; Trial primary completion date: Aug 2021 ➔ Apr 2022

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

"XAV-19 médicament fantôme." (@peinture_huile)

Antibody and cellular therapies for treatment of covid-19: a living systematic review and network meta-analysis. (PubMed, BMJ) - "In patients with non-severe covid-19, casirivimab-imdevimab probably reduces hospitalisation; bamlanivimab-etesevimab, bamlanivimab, and sotrovimab may reduce hospitalisation. Convalescent plasma, IVIg, and other antibody and cellular interventions may not confer any meaningful benefit."

Journal • Retrospective data • Review • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

POLYCOR: Study to Evaluate the Safety and Efficacy of XAV-19 in Patients With COVID-19 Induced Moderate Pneumonia (clinicaltrials.gov) - P2; N=416; Active, not recruiting; Sponsor: Nantes University Hospital; Recruiting ➔ Active, not recruiting; Trial primary completion date: Dec 2020 ➔ Dec 2021

Clinical • Enrollment closed • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Pneumonia

Pharmacokinetics and safety of XAV-19, a swine glyco-humanized polyclonal anti-SARS-CoV-2 antibody, for COVID-19-related moderate pneumonia: a randomized, double-blind, placebo-controlled, phase IIa study. (PubMed, Antimicrob Agents Chemother) - P2 | " Single intravenous dose of 2mg/kg of XAV-19 demonstrated high serum concentrations, predictive of potent durable neutralizing activity with good tolerability. Trial registration: ClinicalTrials.gov Identifier: NCT04453384."

Clinical • Journal • P2a data • PK/PD data • Immunology • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

Efficacy and Safety of XAV-19 for the Treatment of Moderate-to-severe COVID-19 (clinicaltrials.gov) - P2/3; N=722; Recruiting; Sponsor: Xenothera SAS

New P2/3 trial • Infectious Disease • Novel Coronavirus Disease

XENOTHERA And Its Partner Excelya Announce the Recruitment of the First Patient in The EUROXAV Clinical Trial of its COVID Treatment XAV-19 (Businesswire) - "The biotech company XENOTHERA has begun the European clinical trial of its anti-COVID treatment, XAV-19. The Nantes laboratory is the sponsor of the trial, called EUROXAV, which will be carried out by Excelya...EUROXAV is a multi-center, double-blind phase III trial that will recruit 722 patients with moderate COVID, hospitalized or monitored remotely. The trial will take place in Greece, Bulgaria, Romania, Spain and Turkey. The first patient in the trial was recruited on April 28th at Professor Poulakou's center (GR04) in Greece. The cohort of 722 patients will complement the 398 patients in the POLYCOR trial, a trial carried out in 35 French hospitals under the sponsorship of the Nantes University Hospital, which has just closed its recruitment phase with results expected Summer 2021."

Enrollment status • P2 data • Trial status • Infectious Disease • Novel Coronavirus Disease

Evaluation of the safety and efficacy of XAV-19 in patients with COVID-19-induced moderate pneumonia: study protocol for a randomized, double-blinded, placebo-controlled phase 2 (2a and 2b) trial. (PubMed, Trials) - P=N/A, P2 | "This study will determine the clinical benefits of XAV-19 when administered to patients with SARS-CoV-2-induced moderate pneumonia. As a prerequisite, a first step of the study will define the safety and the dose of XAV-19 to be used. Such treatment might become a new therapeutic option to provide an effective treatment for COVID-19 patients (possibly in combination with anti-viral and immunotherapies). Further studies could later evaluate such passive immunotherapy as a potential post-exposure prophylaxis."

Clinical • Journal • P2 data • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

Efficacy and safety of XAV-19 for the treatment of moderate to severe COVID-19 Αποτελεσματικότητα και ασφάλεια του XAV-19 για τη θεραπεία μέτριας έως βαριάς μορφής COVID-19 (clinicaltrialsregister.eu) - P2/3; N=722; Ongoing; Sponsor: XENOTHERA

Clinical • New P2/3 trial • Infectious Disease • Novel Coronavirus Disease

High neutralizing potency of swine glyco-humanized polyclonal antibodies against SARS-CoV-2. (PubMed, Eur J Immunol) - "The IgG fraction purified and formulated following clinical Good Manufacturing Practices, named XAV-19, neutralized Spike/angiotensin converting enzyme-2 (ACE-2) interaction at a concentration < 1 μg/mL and inhibited infection of human cells by SARS-CoV-2 in cytopathic assays...We also found that pig GH-pAb Fc domains fail to interact with human Fc receptors, thereby avoiding macrophage dependent exacerbated inflammatory responses and a possible antibody-dependent enhancement (ADE). These data and the accumulating safety advantages of using GH-pAbs in humans warrant clinical assessment of XAV-19 against COVID-19."

Journal • Allergy • Immunology • Infectious Disease • Inflammation • Novel Coronavirus Disease • Respiratory Diseases

POLYCOR: Study to Evaluate the Safety and Efficacy of XAV-19 in Patients With COVID-19 Induced Moderate Pneumonia (clinicaltrials.gov) - P2; N=368; Recruiting; Sponsor: Nantes University Hospital; Not yet recruiting ➔ Recruiting; Trial completion date: Sep 2021 ➔ Dec 2021

Clinical • Enrollment open • Trial completion date • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

A study to evaluate the safety and efficacy of XAV-19 in patients with COVID-19 induced moderate pneumonia Etude pour évaluer la sécurité et l'efficacité du XAV-19 chez des patients COVID-19 atteints de pneumonie modérée à COVID-19 (clinicaltrialsregister.eu) - P1/2; N=368; Ongoing; Sponsor: Nantes CHU

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