Takeda and Frazier Healthcare Partners Announce Collaboration to Launch HilleVax, Inc. to Develop Clinical Stage Norovirus Vaccine Candidate

Takeda Pharmaceutical Company Limited and Frazier Healthcare Partners (Frazier) announced a collaboration to launch HilleVax, Inc. (HilleVax), 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 acte 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.

Ursula Belinda Myles, General Manager of Takeda’s Access Market Cluster (covering much of Africa) commented: “Africa’s underlying burden of endemic diseases is one of the largest in the world, and infectious diseases play a larger portion of these diseases across the continent. Like many other nations, COVID-19 has emphasized Africa’s greatest challenges around healthcare and highlighted the need for continued greater investment in healthcare systems. These investments are critical to secure economic development as Africa implements flagship projects around the 2030 Africa Health Strategy.”

Ursula added: “The announcement of our partnership with Frazier Healthcare Partners will allow Takeda to focus efforts and resources on vaccines for diseases prevalent across Africa and provide support in alleviating the growing burden that infectious diseases have on public health systems.”

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.3 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.3 No vaccines are currently approved for norovirus 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,” said Rajeev Venkayya, M.D., President of the Global Vaccine Business Unit, Takeda. “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 programs, and our partnership with the US Government to develop a Zika vaccine.”