- Icosavax Inc announced the results of an end-to-end drug product investigation of IVX-411, a VLP vaccine candidate displaying the SARS-CoV-2 receptor-binding domain (RBD).
- The investigation followed the company's Phase 1/2 topline interim data results.
- The immunologic response observed for IVX-411 was inconsistent with expectations based on known data for the company's platform and VLP technology.
- The investigation involved a review of in vitro antigen stability and characterization and in vivo potency, as well as a review of data and protocols relating to the transport, storage, and administration.
- Also Read: Icosavax Shares Plummet Following Interim Results From Initial-Stage RSV Vaccine Study.
- Results of the investigation confirmed the company's initial hypothesis that the reduced potency observed for IVX-411 was antigen-specific.
- No similar pattern of instability has been seen in data to date in other Icosavax vaccine candidates, including for RSV and hMPV.
- The company now focuses on a bivalent strategy for COVID-19 candidate development displaying computationally engineered RBD antigens. Candidate selection is expected in 2023.
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