New Haven-based Biohaven has granted Ono Pharmaceutical an exclusive license to develop and commercialize its MoDE IgG degrader portfolio in Japan, South Korea, Taiwan and Association of Southeast Asian Nations member states, led by BHV-1300, an investigational drug in Phase 3 development for Graves' disease.
Biohaven will receive up to $100 million in near-term payments, including $80 million upon closing and $20 million upon a milestone expected within a year, plus royalties of approximately 20 percent on net sales. It retains rights elsewhere, including the United States, Europe and China.
Vlad Coric, M.D., chairman and chief executive officer of Biohaven, said the agreement validates the platform. "Ono will be the ideal partner to bring this innovative immune-modulating technology to patients across Japan and key Asian markets. This is the first regional collaboration for an extracellular protein degrader, and it validates a platform that began with pioneering chemistry from the Spiegel Lab at Yale University and now spans a broad and diverse portfolio of MoDE and TRAP degraders. Few companies in the world can match Ono's innovation in drug development or its demonstrated ability to translate breakthrough science into transformative therapies, as it did in helping to define modern cancer immunotherapy. We are excited for an outstanding collaboration to accelerate new therapeutics to patients."
BHV-1300 is designed to remove IgG1, IgG2 and IgG4 while sparing IgG3 and is self-administered by autoinjector. In a Phase 1b study in Graves' disease, Biohaven reported deep reduction in the autoantibody to the TSH receptor and rapid normalization of free T3 and free T4.
Ono framed the deal as part of its focus on immunology and inflammation. "Biohaven has a strong track record of developing innovative therapeutics leveraging its proprietary drug discovery platforms," said Toichi Takino, Ph.D., president and chief operating officer of Ono. "Through this collaboration, we aim to strengthen our late-stage pipeline in the immunology and inflammation field, one of Ono's key focus areas. We look forward to working with Biohaven to advance the development program with the goal of providing a new therapeutic to patients with Graves' disease in Japan, South Korea, Taiwan and ASEAN countries and to maximize the value of this treatment."
The agreement is the first regional collaboration for an extracellular protein degrader from Biohaven's platform, which originated in the Yale University laboratory of Dr. David Spiegel.
Tova Gardin, M.D., chief translational officer of Biohaven, said the partnership offers a faster path to patients in key markets. "Pairing BHV-1300 with Ono's regional development and commercial excellence gives this portfolio its strongest and fastest path to patients in two of the world's most important pharmaceutical markets, while securing meaningful non-dilutive capital and retaining substantial long-term upside for our shareholders."
