- Icosavax Inc (NASDAQ:ICVX) has announced topline interim results from its ongoing Phase 1/2 trial of IVX-411, a VLP vaccine candidate displaying the SARS-CoV-2 receptor-binding domain (RBD).
- In the naïve setting, adjuvant effect on immunogenicity and a dose-response were observed with IVX-411. However, the level of immune response was comparable to or below the Human Convalescent Sera (HCS) control.
- At day 49, responses were up to 154 IU/mL across dosage groups in the live virus neutralization assay (HCS: 281 IU/mL) and up to 592 BAU/mL across groups in the spike IgG assay (HCS: 361 BAU/mL).
- Pre-versus post-boost fold increases of up to 5x (599 IU/mL) for wild-type virus were observed at day 28 post boost.
- For the omicron variant, neutralizing antibody titers were up to 8-fold lower than observed for wild-type virus.
- IVX-411 was generally safe and well-tolerated. Solicited local and systemic adverse events (AEs) were mild or moderate, without dose-limiting reactogenicity.
- Icosavax will share interim data from the lead RSV program, IVX-121, in 2Q 2022,
- It expects to initiate Phase 1 trial of the combination vaccine candidate, IVX-A12 against RSV and human metapneumovirus, in 2H 2022.
- Price Action: ICVX shares are down 16.8% at $10.35 during the premarket session on the last check Friday
