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A No-Go for HilleVax as Norovirus Vaccine Fails Mid-Stage Test in Infants

A No-Go for HilleVax as Norovirus Vaccine Fails Mid-Stage Test in Infants

Norovirus has long eluded the best efforts of vaccine developers, and biotech company HilleVax now finds itself a part of that trend. The company’s lead norovirus vaccine candidate, which previously posted positive efficacy data in adults, fell well short of achieving that goal in infants. The company said Monday it is stopping further work on this program in infants and is evaluating the prospects for continuing the vaccine’s development in adults.

HilleVax’s vaccine, HIL-214, employs a virus-like particle, or VLP. Such particles mimic the features and characteristics of a live viral particle in order to prompt an immune response. But because a VLP contains no live virus, it cannot replicate and cause infection. HIL-214 is specifically designed to represent the two groups of norovirus viral strains responsible for most infections in humans.

HIL-214 was evaluated in a placebo-controlled Phase 2b study that enrolled 1,339 infants in the U.S. and Latin America. The main goal was to measure efficacy against moderate or severe gastrointestinal acute gastroenteritis events, such as diarrhea and vomiting. HilleVax reported 51 such events in the clinical trial — 25 in the vaccine group and 26 in the placebo arm. These results translate to vaccine efficacy of 5%. No clinical benefit was observed across secondary endpoints of the trial. In a prepared statement, HilleVax CEO Rob Hershberg said the company believes the efficacy result in the infant study was due to the appearance of multiple emerging strains in one of the groups of viral strains covered by the vaccine.

HilleVax said HIL-214’s safety and immunogenicity profile was consistent with the prespecified analysis of the first 200 participants in the infant study as well as earlier studies of the vaccine. In Phase 2 testing in adults, HIL-214 was well tolerated by study participants, HilleVax previously reported. That clinical trial led to statistically significant measures of efficacy against moderate or severe acute gastroenteritis events due to norovirus.

HIL-214 traces its origins to LigoCyte Pharmaceuticals, a company that Takeda Pharmaceutical acquired in 2012. In 2021, Takeda spun out HilleVax as a standalone company with HIL-214 as its main vaccine asset. The following year, HilleVax raised $200 million from its IPO. HilleVax holds rights to develop HIL-214 in all global markets except for Japan, where Takeda retains rights. Takeda also continues to own a minority stake in HilleVax.

If HilleVax opts to completely drop HIL-214 from its pipeline, it has a Phase 1-ready vaccine candidate ready to take its place. In January, HilleVax acquired a norovirus vaccine candidate developed by China-based Chengdu Kangua Biological Products Co. HilleVax paid $15 million up front for this vaccine’s global rights, excluding China. Another $255.5 million is tied to the achievement of milestones. While this vaccine candidate, now named HIL-216, is also a VLP, it offers a broader scope. HIL-216 addresses six groups of norovirus viral strains, including the two covered by HIL-214. HilleVax has said it expects to begin Phase 1 testing of HIL-216 in late 2024.

In a note sent to investors on Monday, Leerink Partners analyst David Risinger wrote that HIL-214’s earlier positive mid-stage clinical data in adults make it reasonable to believe that another adult study won’t replicate the disappointing results of the infant trial.

“There may still be a path forward for this vaccine and/or next-gen hexavalent, HIL-216, in adults, and we await future company updates in coming months,” he wrote. “Importantly, norovirus vaccines may offer protection for adults effectively as a booster (since virtually all adults have been exposed to norovirus in their lifetimes).”

Nonetheless, news of the failed clinical trial dealt a blow to shares of HilleVax, which fell sharply and closed Monday at $1.64 apiece, down 88.3% from Friday’s closing price. As of the end of the first quarter of this year, HilleVax reported a $272.7 million cash position, which the company estimated would be sufficient to support the company for at least the next 12 months.

Public domain image of norovirus by the Centers for Disease Control and Prevention

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