Takeda Pharmaceutical Company Limited and Frazier Healthcare Partners announced a collaboration to launch HilleVax, Inc, a biopharmaceutical company, to develop and commercialize Takeda’s norovirus vaccine candidate.
Takeda has granted a license to HilleVax for the exclusive development and commercialization rights to its norovirus vaccine candidate, HIL-214 (formerly TAK-214), worldwide outside of Japan.
Takeda will retain commercialization rights in Japan and HilleVax will integrate certain Japan development activities into its global development. Takeda remains committed to vaccines and this collaboration allows Takeda to focus primarily on dengue, Covid-19, pandemic influenza and Zika.
HIL-214, which is a virus-like particle (VLP) based vaccine candidate, completed a randomized, placebo-controlled phase 2b field efficacy study in 4,712 adult subjects in which HIL-214 was well-tolerated and demonstrated clinical proof of concept in preventing moderate-to-severe cases of acute gastroenteritis from norovirus infection.
To date, the candidate has been studied in nine human clinical trials with safety data from over 4,500 subjects and immunogenicity data from over 2,000 subjects.
Norovirus is a common intestinal infection marked by diarrhea, vomiting, abdominal cramps, nausea and sometimes fever that may lead to clinically significant dehydration.
Norovirus is recognized as the leading cause of acute gastroenteritis across the age spectrum. It is estimated that norovirus causes nearly 700 million cases of illness and more than 200,000 deaths worldwide per year with significant additional economic and social burden.
No vaccines are currently approved for norovirus infection, and HIL-214 continues to be the most advanced norovirus vaccine candidate in human clinical trials.