IVX-A12 / AstraZeneca - LARVOL DELTA

A Study to Evaluate the Safety and Immunogenicity of IVX-A12 in Participants of 60 to 85 Years of Age (clinicaltrials.gov) - P2 | N=264 | Completed | Sponsor: Icosavax, Inc. | Active, not recruiting ➔ Completed

Trial completion • Respiratory Diseases • Respiratory Syncytial Virus Infections

RSV Vaccines: Targeting Prefusion F and G Proteins from Structural Design to Clinical Application. (PubMed, Vaccines (Basel)) - " Approved vaccines such as Abrysvo and Arexvy utilize structural engineering to stabilize the prefusion conformation of the F protein (PreF), thereby exposing neutralizing epitopes. Subunit vaccine candidates such as DS-Cav1 and DT-PreF enhance stability through disulfide bonds and dityrosine linkages, while ADV110 targets the conserved domain of the G protein to elicit cross-strain immunity. Virus-like particle (VLP) vaccines like IVX-A12 combine RSV and human metapneumovirus antigens to provide broad-spectrum immunity. However, challenges exist, including maintaining PreF stability, overcoming immunosenescence in the elderly, and addressing safety concerns like Guillain-Barré syndrome (GBS). Future RSV vaccine development should center on combined PreF-G protein vaccines, VLP technology, and optimizing cold-chain logistics to improve global accessibility and overcome existing challenges, thereby providing more effective prevention and control of RSV infections."

Journal • Review • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections • CAV1

A Study of IVX-A12 in Adults Participants (clinicaltrials.gov) - P2 | N=143 | Completed | Sponsor: Icosavax, Inc. | Active, not recruiting ➔ Completed

Trial completion

A Randomized Phase 1 Clinical Trial of a Respiratory Syncytial Virus and Human Metapneumovirus Combination Protein-Based Virus-like Particle Vaccine in Adults 60-75 Years of Age. (PubMed, Open Forum Infect Dis) - P1 | "IVX-A12 was well-tolerated and elicited RSV- and hMPV-specific antibody responses in adults 60-75 years of age. These data support the ongoing clinical development of the RSV/hMPV combination VLP vaccine IVX-A12."

Journal • P1 data • Respiratory Diseases • Respiratory Syncytial Virus Infections

The Silent Threat of Human Metapneumovirus: Clinical Challenges and Diagnostic Insights from a Severe Pneumonia Case. (PubMed, Microorganisms) - "This case underscores the importance of rapid molecular diagnostics for hMPV, reducing unnecessary antibiotics and enhancing management. Routine incorporation of hMPV testing into clinical protocols could improve the diagnosis and resource use. The development of vaccines, such as the IVX-A12 in phase II trials, offers hope for targeted prevention, underscoring the need for further research and therapeutic innovations."

Journal • Cough • Fatigue • Infectious Disease • Pediatrics • Pneumonia • Respiratory Diseases

A Study of IVX-A12 in Adults Participants (clinicaltrials.gov) - P2 | N=143 | Active, not recruiting | Sponsor: Icosavax, Inc.

New P2 trial

A Study to Evaluate the Safety and Immunogenicity of IVX-A12 in Participants of 60 to 85 Years of Age (clinicaltrials.gov) - P2 | N=264 | Active, not recruiting | Sponsor: Icosavax, Inc. | Trial completion date: Sep 2024 ➔ Sep 2025 | Trial primary completion date: May 2024 ➔ Jul 2025

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

A Study to Evaluate the Safety and Immunogenicity of IVX-A12 in Participants of 60 to 85 Years of Age (clinicaltrials.gov) - P2 | N=264 | Active, not recruiting | Sponsor: Icosavax, Inc. | Phase classification: P2a ➔ P2 | Trial primary completion date: Oct 2023 ➔ May 2024

Phase classification • Trial primary completion date • Respiratory Diseases • Respiratory Syncytial Virus Infections

Safety and Immunogenicity of IVX-A12 in Healthy Older Adults (clinicaltrials.gov) - P1 | N=140 | Completed | Sponsor: Icosavax, Inc. | Active, not recruiting ➔ Completed | Trial primary completion date: Jan 2023 ➔ Jan 2024

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

Acquisition of Icosavax Completed (AstraZeneca Press Release) - "AstraZeneca announced today the successful completion of the acquisition of Icosavax, Inc...As a result of the acquisition, Icosavax has become a subsidiary of AstraZeneca, with operations in Seattle, US...The acquisition will build on AstraZeneca’s expertise in respiratory syncytial virus (RSV), strengthening AstraZeneca’s Vaccines & Immune Therapies late-stage pipeline with Icosavax’s lead investigational vaccine candidate, IVX-A12...The acquisition was completed through a tender offer to purchase all outstanding shares of Icosavax for a price of $15.00 per share in cash up front, plus a non-tradable contingent value right for up to $5.00 per share in cash, payable upon achievement of a specified regulatory milestone and a specified sales milestone, which was followed by a statutory merger through which all shares of Icosavax stock that had not been validly tendered were converted into the right to receive the same consideration."

M&A • Respiratory Syncytial Virus Infections

A Study to Evaluate the Safety and Immunogenicity of IVX-A12 in Participants of 60 to 85 Years of Age (clinicaltrials.gov) - P2a | N=264 | Active, not recruiting | Sponsor: Icosavax, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Respiratory Diseases • Respiratory Syncytial Virus Infections

Safety and Immunogenicity of IVX-A12 in Healthy Older Adults (clinicaltrials.gov) - P1 | N=120 | Active, not recruiting | Sponsor: Icosavax, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Study to Evaluate the Safety and Immunogenicity of IVX-A12 in Participants of 60 to 85 Years of Age (clinicaltrials.gov) - P2a | N=250 | Recruiting | Sponsor: Icosavax, Inc.

New P2a trial • Respiratory Diseases • Respiratory Syncytial Virus Infections

Icosavax Granted FDA Fast Track Designation for IVX-A12 (GlobeNewswire) - "Icosavax...announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for IVX-A12, a bivalent respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) VLP vaccine candidate, in older adults 60 years of age and above."

Fast track designation • Infectious Disease • Respiratory Syncytial Virus Infections

Safety and Immunogenicity of IVX-A12 in Healthy Older Adults (clinicaltrials.gov) - P1 | N=120 | Recruiting | Sponsor: Icosavax, Inc.

New P1 trial • Respiratory Diseases • Respiratory Syncytial Virus Infections