Astellas Pharma and Australian biotechnology company Audax Biosciences Pty have entered into an exclusive option and license agreement for DAX-044, Audax’s lead immuno-oncology candidate. The agreement gives Astellas an exclusive option to obtain a worldwide license to develop, manufacture and commercialise the investigational therapy. Audax will also have the option to co-fund and co-promote DAX-044 in Australia and New Zealand.

The agreement strengthens Astellas’ immuno-oncology pipeline, which is one of the primary focus areas of its research and development strategy, and complements the company’s portfolio of targeted immunotherapy approaches.

Takahiko Iwaya, Chief Strategy Officer at Astellas, said the collaboration combines Audax’s scientific research with Astellas’ expertise in drug development, manufacturing and commercialisation. He noted that DAX-044 is an investigational immuno-oncology programme designed to selectively activate anti-tumour immune responses and could support the development of new treatment options for patients with solid tumours, including cancers where effective immune stimulation remains a therapeutic challenge.

Jai Rautela, Ph.D., MBA, Chief Executive Officer of Audax Biosciences, said Astellas was a suitable partner for the programme because of its focus on immuno-oncology. He added that the collaboration is expected to accelerate the planned Phase 1 clinical evaluation of DAX-044 and reflects confidence in Audax’s approach to developing novel therapies. The agreement also provides an opportunity for Audax to participate in the programme’s development in its home market.

DAX-044 is an investigational interleukin-12 (IL-12) antibody-cytokine fusion designed using Audax’s Avikine technology. The candidate aims to concentrate IL-12’s immune-activating activity within the tumour microenvironment while limiting systemic toxicity, which has historically restricted the clinical application of IL-12-based therapies. According to the companies, preclinical studies have indicated the potential for a favourable therapeutic index. DAX-044 is currently in the Investigational New Drug (IND) and Clinical Trial Notification (CTN)-enabling development stage.

Under the agreement, Audax will receive upfront and potential future option exercise payments totalling USD 285 million. Audax will continue developing DAX-044 towards a Phase 1 clinical study, which is expected to commence in 2027.

If Astellas exercises its option, it will assume sole responsibility for the candidate’s global development, manufacturing and commercialisation. Audax will retain the option to co-fund and co-promote the therapy in Australia and New Zealand. In addition, Audax will be eligible for development and commercial milestone payments of up to USD 1.05 billion, along with tiered double-digit royalties on worldwide net sales if the candidate receives regulatory approval.