Icosavax Initiates Phase 1/2 Trial of COVID-19 VLP Vaccine Candidate

Icosavax, Inc. announced the first subjects have been dosed with IVX-411, a virus-like particle (VLP) displaying the SARS-CoV-2 receptor-binding domain (RBD), in a Phase 1/2 clinical trial. As previously announced, the Phase 1/2 trial is being funded by the Bill & Melinda Gates Foundation. Amgen is manufacturing a key intermediate, and Seqirus is providing its proprietary MF59® adjuvant for this trial.

“We believe a variety of vaccine approaches, including boosters, will be needed to continue the fight against COVID-19,” said Adam Simpson, Chief Executive Officer of Icosavax. “We are pleased to be working with Seqirus to evaluate MF59 in combination with IVX-411, our COVID-19 VLP vaccine candidate. Subject to successful clinical development, we believe that IVX-411 could become a leading next generation vaccine against SARS-CoV-2, particularly for older adults who have a diminished immune response.”

The Phase 1/2 clinical trial is a randomized, observer-blinded, placebo-controlled trial designed to evaluate the safety and immunogenicity of adjuvanted and unadjuvanted IVX-411. The trial is enrolling up to 168 healthy volunteers (18 to 69 years of age) in Australia. The Phase 1 part of the trial will enroll SARS-CoV-2 seronegative adults who have not had COVID-19 and have not been vaccinated with a licensed COVID-19 vaccine. The Phase 2 part of the trial will enroll SARS-CoV-2 seropositive adults who have completed a vaccine regimen using a licensed COVID-19 vaccine.

The trial will evaluate different dose levels of adjuvanted and unadjuvanted IVX-411 to help determine if an adjuvant may boost the immune response and potentially reduce the amount of antigen required for protection against SARS-CoV-2.

“We are delighted that Seqirus’ proprietary adjuvant MF59 will be evaluated in combination with Icosavax’s virus-like particles,” said Russell Basser, M.D., Senior Vice President of Research and Development at Seqirus. “As a company dedicated to protecting millions of people around the world each year from influenza, Seqirus is happy to partner with Icosavax to advance a next generation vaccine solution in the global fight against COVID-19.”