Takeda Pharmaceutical Company Limited and Frazier Healthcare Partners have collaborated to launch HilleVax, Inc. (HilleVax), a biopharmaceutical company to develop and commercialise Takeda’s norovirus vaccine candidate. Takeda has granted a licence to HilleVax for the exclusive development and commercialisation rights to its norovirus vaccine candidate, HIL-214 (formerly TAK-214), worldwide outside of Japan, the company said in a statement.

It added that Takeda will retain commercialisation rights in Japan and HilleVax will integrate certain Japan development activities into its global development. 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 randomised, 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, mentioned the statement.

Speaking in this regard, Simon Gallagher, Interim General Manager, Takeda India, commented, “With a third of the global population in India, there is a higher level of risk to people from viruses and infectious diseases. Today, there is sufficient proof and data that vaccinations have contributed to a decrease in infectious diseases and associated mortality rates. This partnership announcement between Takeda and Frazier Healthcare Partners will allow Takeda to continue developing treatments for high-risk and high-burden diseases prevalent in India, such as dengue and Zika virus, while alleviating some of the immense pressures on public healthcare institutions across the country due to the ongoing COVID-19 global pandemic.”

The statement further notified that norovirus is a common intestinal infection marked by diarrhoea, vomiting, abdominal cramps, nausea, and sometimes, fever, that may lead to clinically significant dehydration. It is recognised 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 a significant additional economic and social burden. No vaccines are currently approved for this infection, and HIL-214 continues to be the most advanced norovirus vaccine candidate in human clinical trials.

“Takeda and Frazier have a history of successfully partnering together, and we are confident in HilleVax’s capabilities to progress HIL-214, the most advanced norovirus vaccine candidate in development with the potential to address the huge global burden of norovirus-associated acute gastroenteritis. This will allow Takeda to focus its efforts and resources on our dengue vaccine, which we have begun filing for licensure around the world, our pandemic programmes, and our partnership with the US Government to develop a Zika vaccine,” said Rajeev Venkayya, MD, President, Global Vaccine Business Unit, Takeda.