VYD2311 / Invivyd - LARVOL DELTA

Safety, tolerability, pharmacokinetics, and immunogenicity in a phase I first-in-human study with VYD2311, a SARS-CoV-2-directed monoclonal antibody (ESCMID Global 2026) - No abstract available

Clinical • First-in-human • P1 data • PK/PD data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Characterisation of monoclonal antibody VYD2311: molecular structure and in vitro neutralisation profile against recent SARS-CoV-2 variants (ESCMID Global 2026) - No abstract available

Preclinical • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

DECLARATION: Study of VYD2311 for the Prevention of COVID-19 (clinicaltrials.gov) - P3 | N=1770 | Recruiting | Sponsor: Invivyd, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Novel Coronavirus Disease

DECLARATION: Study of VYD2311 for the Prevention of COVID-19 (clinicaltrials.gov) - P3 | N=1770 | Not yet recruiting | Sponsor: Invivyd, Inc.

New P3 trial • Infectious Disease • Novel Coronavirus Disease

Invivyd Earns Fast Track Designation for VYD2311, a Vaccine-Alternative Antibody to Prevent COVID (GlobeNewswire) - "Invivyd previously announced initiation of DECLARATION, the company’s BLA-enabling clinical trial of VYD2311. Top-line data from the trial are expected mid-2026....DECLARATION is a Phase 3, randomized, triple-blind, placebo-controlled trial to evaluate VYD2311 safety and efficacy in prevention of symptomatic COVID in a broad population of participants including adults and adolescents both with and without underlying risk factors for progression to severe COVID-19, at three months."

Fast track • New P3 trial • P3 data: top line • Novel Coronavirus Disease

Invivyd Announces U.S. IND Clearance and Alignment with U.S. FDA on Pivotal Clinical Program for VYD2311, a Vaccine-Alternative Antibody to Prevent COVID (GlobeNewswire) - "The DECLARATION (safety and efficacy vs. placebo) and LIBERTY (exploratory safety head-to-head and combination with mRNA-based COVID vaccination) clinical trials are expected to begin around year-end 2025; top-line data anticipated mid-2026."

IND • New P3 trial • P3 data: top line • Novel Coronavirus Disease

Structure of VYD2311 & in vitro neutralisation against a panel of contemporary SARS-CoV-2 variants (ESCMID Global 2025) - No abstract available

Preclinical • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

FDA Declined Invivyd’s Request to Expand Existing Emergency Use Authorization of PEMGARDA (pemivibart) to Include Treatment of Mild-to-Moderate COVID-19 For Immunocompromised Persons Who Have No Alternative Therapeutic Options; No Change to the Existing PEMGARDA EUA for Pre-Exposure Prophylaxis of COVID-19 in Certain Immunocompromised Patients (GlobeNewswire) - "Invivyd, Inc...today announced that Invivyd’s request to expand the existing emergency use authorization (EUA) for pre-exposure prophylaxis of COVID-19 EUA for PEMGARDA (pemivibart) to provide a treatment option for mild-to-moderate COVID-19 in adults and adolescents who have moderate-to-severe immune compromise due to certain medical conditions such as cancer and organ transplant, and for whom alternative COVID-19 treatment options are not accessible or clinically appropriate, was declined by the U.S. Food and Drug Administration (FDA)...Invivyd plans in the near term to share detailed data and regulatory correspondence regarding pemivibart, VYD2311 and immunobridging of COVID-19 antibodies..."

FDA event • Infectious Disease • Novel Coronavirus Disease

A Study of the Investigational Monoclonal Antibody, VYD2311, in Healthy Participants (clinicaltrials.gov) - P1 | N=40 | Active, not recruiting | Sponsor: Invivyd, Inc. | Recruiting ➔ Active, not recruiting | N=30 ➔ 40

Enrollment change • Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Study of the Investigational Monoclonal Antibody, VYD2311, in Healthy Participants (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Invivyd, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Study of the Investigational Monoclonal Antibody, VYD2311, in Healthy Participants (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Invivyd, Inc.

New P1 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases