Takeda has spun out its norovirus vaccine prospect to create a biotech: HilleVax. Frazier Healthcare Partners has teamed up with Takeda to found HilleVax, providing investor support for a program that cleared phase 2b back in 2018.
The 4,712-subject phase 2b saw too few cases of homotypic norovirus acute gastroenteritis to fully evaluate the primary endpoint. However, with the study linking the vaccine to statistically significant efficacy against any moderate to severe norovirus acute gastroenteritis, researchers saw reasons to continue studying the candidate.
Takeda wrapped up the phase 2b trial more than three years ago. Since then, signs of progress on the program have been rare. Takeda continued a long-term immunogenicity study and added the vaccine to the list of products that could come to market after 2025, but otherwise revealed little progress.
Spinning the vaccine out should get the project moving forward. In return for an upfront fee and milestone and royalty commitments, all of undisclosed size, Takeda has granted HilleVax rights to the vaccine outside of Japan. The license covers a bivalent vaccine based on viruslike particles against two genotypes that have historically accounted for most norovirus outbreaks.
The asset, now known as HIL-214, is the most advanced norovirus candidate in development. Most of the 200,000 deaths associated with the virus occur in low-income countries, but there could also be a market for the vaccine in the West. An estimated 40,000 Army personnel based in the U.S. contract the virus each year, and Takeda conducted the phase 2b at a Navy training facility.
Takeda framed the agreement as a way to enable it to focus on vaccines against dengue, COVID-19, pandemic influenza and Zika. Regulatory submissions for the dengue vaccine began earlier this year.
The creation of HilleVax comes two years after Takeda teamed up with Frazier to found another biotech. In the earlier deal, the partners created Phathom Pharmaceuticals to develop vonoprazan and other treatments for gastrointestinal diseases and disorders. Both spin outs gave Takeda a way to advance candidates, and potentially profit from their success, without committing internal resources.