Pipeline

Our initial program, HIL-214, is a virus-like particle (VLP) based vaccine candidate in development for the prevention of moderate-to-severe acute gastroenteritis caused by norovirus infection.

Norovirus

Norovirus is the most common cause of viral acute gastroenteritis (AGE) worldwide² and is characterized by symptoms, including diarrhea, vomiting, abdominal pain, nausea, and fever, that may lead to clinically significant dehydration. The global cost of norovirus-caused AGE is estimated to be over $4 billion in direct health system costs and approximately $60 billion in societal costs per year³. In the United States alone, norovirus-caused AGE is estimated to result in $2 billion in direct medical costs and $10 billion in societal costs per year⁴.

Preventing the spread of norovirus is challenging as the virus can persist on environment surfaces for weeks and is resistant to common disinfectants⁵. While norovirus can cause illness in any age group, the majority of deaths and illnesses due to norovirus are borne by young children and older adults³. In children younger than four years of age, norovirus is estimated to cause 95,000 deaths and 450 million illnesses globally each year³. Up to 80% of children will experience a norovirus infection within one year of birth, with the majority of cases occurring between six months and two years of age^6,7. For adults older than 55 years of age, norovirus is estimated to cause 78,000 deaths and 81 million illnesses globally each year³.

The impact of norovirus in the United States results in an average of 22 million cases of AGE, 96,000 hospitalizations, and 1,350 deaths annually⁴. For comparison, norovirus has a similar morbidity, mortality, and economic burden in children in the United States as rotavirus did before the introduction of rotavirus vaccines^4,8. Further, norovirus today has a greater morbidity, mortality, and economic burden in United States than shingles before the introduction of shingles vaccines^9,10.

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HIL-214

HilleVax is developing HIL-214, a norovirus bivalent GI.1/GII.4 virus-like particle (VLP) vaccine intended for active immunization for the prevention of acute gastroenteritis (AGE) caused by norovirus. The following chart summarizes our current development program:

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HIL-214 has been the subject of nine Phase 1 and Phase 2 clinical trials, including more than 4,500 subjects of which more than 2,200 subjects have been evaluated for immunogenicity. These subjects have ranged from 6 weeks to 102 years old. In a randomized, placebo-controlled Phase IIb field efficacy study in 4,712 adult subjects, HIL-214 was shown to be well-tolerated and demonstrated clinical proof of concept in preventing moderate-to-severe cases of acute gastroenteritis from norovirus infection¹¹.

KEY PUBLICATIONS

REFERENCES

^[1] Karst, S. M. Pathogenesis of Noroviruses, Emerging RNA Viruses. Viruses 2, 748–781 (2010)

^[2] Centers for Disease Control (CDC). Norovirus Worldwide [Accessed on: 22 December 2021], available from: https://www.cdc.gov/norovirus/trends-outbreaks/worldwide.html

^[3] Bartsch, S. M., Lopman, B. A., Ozawa, S., Hall, A. J. & Lee, B. Y. Global Economic Burden of Norovirus Gastroenteritis. Plos One 11, e0151219 (2016)

^[4] Bartsch, S. M., O’Shea, K. J. & Lee, B. Y. The Clinical and Economic Burden of Norovirus Gastroenteritis in the United States. J Infect Dis 222, 1910–1919 (2020)

^[5] Centers for Disease Control (CDC). CDC Vitalsigns [Accessed on: 22 December 2021], available from: https://www.cdc.gov/vitalsigns/pdf/2014-06-vitalsigns.pdf

^[6] Saito, M. et al. Multiple Norovirus Infections in a Birth Cohort in a Peruvian Periurban Community. Clin Infect Dis 58, 483–491 (2014)

^[7] Shioda, K., Kambhampati, A., Hall, A. J. & Lopman, B. A. Global age distribution of pediatric norovirus cases. Vaccine 33, 4065–4068 (2015)

^[8] Centers for Disease Control (CDC). Rotavirus Pinkbook [Accessed on 22 December 2021], available from: https://www.cdc.gov/vaccines/pubs/pinkbook/rota.html

^[9] Harvey, M., Prosser, L. A., Rose, A. M., Ortega-Sanchez, I. R. & Harpaz, R. Aggregate health and economic burden of herpes zoster in the United States: illustrative example of a pain condition. Pain 161, 361–368 (2019)

^[10] Legami, V. D. et al. Epidemiology and costs of herpes zoster: Background data to estimate the impact of vaccination. Vaccine 25, 7598–7604 (2007)

^[11] Sherwood, J. et al. Efficacy of an intramuscular bivalent norovirus GI.1/GII.4 virus-like particle vaccine candidate in healthy US adults. Vaccine 38, 6442–6449 (2020)