Astellas pays $285m for Audax cancer drug, and other deals
Astellas has taken an option on a cancer immunotherapy candidate developed by Australia's Audax Bio, currently in preclinical development, for up to $1.34 billion.
The Japanese group is paying $285 million upfront for a worldwide license to DAX-044, an IL-12 antibody-cytokine fusion, designed to deliver the anti-cancer benefits of stimulating the cytokine without the side effects that have plagued other IL-12-directed candidates.
Several studies of IL-12 immunotherapies have shown encouraging results in animal models, but in human testing they have been associated with modest anti-tumour effects and a range of side effects, including systemic flu-like symptoms, liver toxicity, and cytokine release syndrome (CRS).
Audax Bio – previously known as oNKo-innate – said its candidate has been developed using its Avikine platform, which is designed to selectively concentrate IL-12 immune-stimulating activity within the tumour microenvironment and minimise it in healthy tissues.
Along with the upfront payment, Astellas is also offering up to $1.05 billion in development and commercial milestones, and Audax will continue with plans to start a phase 1 trial of DAX-044 in early 2027.
If Astellas chooses to exercise its option, the Australian biotech will retain co-funding and co-promotion rights to the drug in its home market and New Zealand, with the Japanese group responsible for the drug’s global development, manufacturing and rollout if it reaches the market.
"By combining Audax's innovative science with Astellas' development, manufacturing and commercialisation expertise, we hope to advance a potential new treatment option for patients with solid tumours, including cancers where effective immune stimulation remains an important therapeutic challenge," said Astellas' chief strategy officer Takahiko Iwaya.
The company has made finding new precision therapies for hard-to-treat cancers with gaps in treatment options – including gastrointestinal, genitourinary, and lung cancers – a cornerstone of its aspirations in oncology.
Its cancer pipeline is currently headed by KRAS G12D degrader setidegrasib, in phase 3 for pancreatic and non-small cell lung cancer (NSCLC).
Teva and Gilead bolt-on new assets
In the last few days, Teva added to its pipeline by snapping up some of the assets of recently-bankrupt US biopharma company BioXcel Therapeutics, while Gilead Sciences bolted on a new immunology and inflammation (I&I) candidate from China's PepStar Therapeutics.
The Gilead deal is by far the larger of the two, involving an upfront payment of $1.275 billion for rights to HCXT-2001, an oral drug hitting the same target as blockbuster injectable immunology and inflammation (I&I) therapies, like Johnson & Johnson's Tremfya (guselkumab) and AbbVie's Skyrizi (risankizumab). It could be a rival to J&J's oral IL-23R drug Icotyde (icotrokinra), recently approved for plaque psoriasis. According to Gilead, HCXT-2001 has an extended half-life, which could reduce dosing frequency, and is currently in phase 1 testing.
In the case of Teva, the company has paid $57.5 million upfront with another $67.5 million in possible milestone and regulatory payments for rights to Igalmi (dexmedetomidine), a treatment for agitation in people with schizophrenia or bipolar disorder, and follow-up BXCL501. The latter is a new formulation of dexmedetomidine that could be dosed at home without healthcare provider supervision.
