Astellas Pharma signs US$1.3B licensing deal with Audax Biosciences for cancer therapy
Under the agreement, Astellas will pay up to US$285 million in upfront and potential future option exercise payments, alongside up to US$1.05 billion in development and commercial milestones.
AUSTRALIA—Astellas Pharma has signed a licensing agreement with Australian biotechnology company Audax Biosciences to develop a targeted cancer therapy, strengthening its oncology pipeline as competition for innovative treatments intensifies.
Under the agreement, Astellas will pay up to US$285 million in upfront and potential future option exercise payments, alongside up to US$1.05 billion in development and commercial milestones.
In return, the Japanese pharmaceutical company will secure exclusive global rights to DAX-044, an antibody-cytokine fusion therapy targeting solid tumours.
Targeting immune activity within tumours
DAX-044 uses Audax’s AVIKINE technology to concentrate the immune-stimulating activity of interleukin-12 (IL-12) within the tumour microenvironment.
The approach aims to limit the systemic toxicity associated with IL-12-based cancer treatments while retaining their potential to stimulate antitumour immune responses.
Audax reports that preclinical studies have demonstrated a favourable therapeutic index for DAX-044 compared with other IL-12-based agents.
The candidate is currently undergoing preparatory studies required before an application to begin human trials.
Astellas will lead its further development, with Phase I clinical trials targeted for 2027.
The agreement gives Astellas responsibility for global development, manufacturing and potential commercialisation.
If the drug reaches the market, Audax can elect to co-fund and co-promote it in Australia and New Zealand.
The Australian company will also be eligible for double-digit tiered royalties on global sales.
Expanding the oncology pipeline
The deal comes as Astellas prepares for the eventual loss of patent protection for Xtandi (enzalutamide), its prostate cancer treatment co-commercialised with Pfizer.
The drug generated ¥960.8 billion(U $6 billion) in revenue in 2025, making it a significant contributor to Astellas’ business.
The agreement also follows Astellas’ US$400 million research collaboration and licensing deal with AI Proteins to design and optimise de novo miniproteins.
Together, the partnerships reflect the company’s investment in emerging therapeutic platforms as pharmaceutical developers seek new growth drivers.
Immuno-oncology attracts investment
The licensing deal comes amid growing interest in targeted cancer therapies and combination treatments.
At the 2026 European Society for Medical Oncology congress, experts highlighted the increasing role of novel combinations in frontline treatment for several cancers that have historically responded poorly to immunotherapy.
These approaches include immune-directed medicines, antibody-drug conjugates, cancer vaccines and bispecific antibodies, which aim to improve treatment responses through more targeted mechanisms.
GlobalData’s latest State of the Biopharmaceutical Industry report also identified immuno-oncology and precision medicine as emerging trends expected to substantially impact the pharmaceutical sector over the next 12 months.
Analysts project that the immuno-oncology market will reach US$186 billion by 2031, driven largely by demand for checkpoint modulators and T-cell engager therapies.
Investment in candidates such as DAX-044 highlights the industry’s continued interest in technologies designed to strengthen antitumour immunity while managing treatment-related toxicity.
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