Icosavax discovers what caused its lead vaccine to flop, and doesn't see it affecting follow-up programs

29 Jul 2022
endpts.com
Vaccine
Seattle-based Icosavax was one of the companies in the rat race to develop Covid-19 vaccine shots better than Pfizer and Moderna. However, when clinical trials showed that its vaccine candidate, IVX-411, fared ‘below expectations,” the company launched an investigation. Now those results are out. The problem, Icosavax says, had to do with the receptor binding domain (RBD) of the antigen component of the vaccine, which became unstable during manufacturing and subsequent storage at 2-8 °C. Icosavax uses a “virus-like particle” (VLP) shaped like a soccer ball, with the “white” parts making up the viral structure and the “black” spots representing the displayed antigens. Mice studies showed that instability of the RBD antigen on the VLP surface translated to a loss of potency for IVX-411, consistent with that seen in the company’s Phase I/II results, the release added. “The results of our comprehensive IVX-411 investigation confirmed our original hypothesis that the lower-than-expected immunogenicity for IVX-411 was likely attributable to an antigen specific stability issue,” said Icosavax CEO Adam Simpson. While analysts had begun to question the biotech’s entire platform after the failure of the Covid-19 vaccineCovid-19 vaccine, some are now seemingly reversing course. “The analysis suggests that there is little read through from IVX-411 to IVX-A12 program or the rest of ICVX’s platform,” said Cowen analyst Phil Nadeau in a note. IVX-A12 is a bivalent vaccine combination of its IVX-121 candidate, designed against respiratory syncytial virus (RSV), and IVX-241, against human metapneumovirus (hMPV), which causes pneumonia. IVX-A12 is being designed to target both RSV and hMPV in a single vaccine candidate. “IVX-A12 continues to look promising, and its development remains on track,” Nadeau added in the note. Meanwhile, a host of companies are gunning to bring the first RSV vaccine to the market, with Pfizer , GSK and an AstraZeneca/Sanofi team all touting late-stage data this year. Pfizer also jumped into the M&A game, buying out the biotech ReViral for $525 million in April to push forward its RSV vaccine program. Share prices of IcosavaxIcosavax $ICVX dropped 6% since yesterday’s market close.
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