TOKYO – October 29, 2026 -- Astellas Pharma Inc. has secured an exclusive option on a worldwide license to Audax Biosciences' immuno-oncology candidate DAX-044 in a transaction worth up to US$1.34 billion, excluding royalties.
Audax receives US$285 million up front and on option exercise
Audax will receive US$285 million in combined up-front and option-exercise payments. It is also eligible for development and commercial milestones of up to US$1.05 billion, plus tiered double-digit royalties on worldwide net sales if DAX-044 is approved.
Audax carries the program into a Phase 1 study expected to start in 2027. DAX-044 is currently in IND/CTN-enabling development.
Astellas takes global control of development and sales on exercise
If Astellas exercises the option, it assumes sole responsibility for global development, manufacturing and commercialization. Audax retains the option to co-fund and co-promote DAX-044 in Australia and New Zealand. Exercise is subject to customary conditions, including antitrust clearances.
Audax warned that the option may never be exercised and that milestone payments may never be received.
IL-12 fusion aims to curb the systemic toxicity that has limited the class
DAX-044 is an investigational interleukin-12 (IL-12) antibody-cytokine fusion built on Audax's AVIKINE technology. It is designed to concentrate IL-12's immune-activating effect in the tumor microenvironment while limiting the systemic toxicity that has historically constrained IL-12-based therapy. Preclinical studies showed a potential best-in-class therapeutic index for an IL-12 agent.
Astellas Chief Strategy Officer Takahiko Iwaya said the program targets solid tumors, including cancers where effective immune stimulation remains a challenge. The deal adds to Astellas' immuno-oncology pipeline, one of the primary focuses of its R&D strategy, and complements its targeted immunotherapy portfolio.
Audax CEO Jai Rautela said the partnership will expedite the planned Phase 1 evaluation and that the deal "demonstrates confidence" in the company's approach to novel therapeutic development. He also cited the potential to co-develop DAX-044 in Audax's home market.