Astellas Pharma has inked a billion-dollar licensing deal with Australian biotech, Audax Biosciences, which will see the company secure access to an immuno-oncology asset the latter says has shown “best-in-class” potential in preclinical studies.
As per the agreement, Astellas will hand over up to $285m in upfront and potential future option exercise payments, as well as up to $1.05bn in development and commercial milestones, in exchange for the exclusive global rights to its solid tumour-targeting IL-12 antibody-cytokine fusion therapy, DAX-044.
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At the core of DAX-044’s approach is Audax’s AVIKINE technology, designed to selectively concentrate IL-12 immune-stimulating activity within the tumour microenvironment, thus limiting the toxicity generally linked to IL-12-based therapies in oncology. According to Audax, DAX-044 has already demonstrated its “best-in-class therapeutic index for an IL-12 agent” in preclinical studies, with the drug currently sitting in the IND-enabling development stage.
With DAX-044 poised to enter the clinic in the near future, Astellas will take the helm in progressing the drug to Phase I trials, with the company hoping to begin an early-stage study on DAX-044 in 2027. Through this licensing deal, the Japanese pharma will also assume complete responsibility for the drug’s global development, manufacturing and potential commercialisation.
If DAX-044 were to make it to market, Audax will secure the rights to co-fund and co-promote the drug in Australia and New Zealand, while gaining access to double-digit tiered royalties on global sales.
Astellas’ deal with Audax comes amid the looming patent expiry of its best-selling Pfizer co-commercialised prostate cancer asset, Xtandi (enzalutamide), which brought in ¥960.8bn (around $6bn) in revenue during 2025.
It also follows on from the Japanese pharma’s recent $400m research collaboration and licensing deal with AI Proteins, which saw the pair join forces to design and optimise de novo miniproteins.
Immuno-oncology turns heads in oncology space
In recent years, there has been a notable shift towards personalisation and targeted therapeutic combinations in the oncology space, with experts at the 2026 European Society of Medical Oncology (ESMO) congress noting that novel combinations are beginning to replace chemotherapy-dominated regimens in the frontline setting of several cold cancers.
This trend, they say, is driven by the continued emergence of efficacious drugs belonging to targeted therapeutic modalities such as immune-directed medicines, antibody-drug conjugates (ADCs), cancer vaccines and bispecifics.
According to the most recent State of the Biopharmaceutical Industry report from GlobalData, parent company of Pharmaceutical Technology, pharma executives rated immuno-oncology and precision medicine as two of the most impactful emerging industry trends to impact the sector in the next 12 months.
This comes as analysts expect the immuno-oncology market’s value to skyrocket in the next few years due primarily to surging sales of checkpoint modulators and T-cell engager therapies – hitting a value of $186bn by 2031.
