Astellas Pharma Inc. [TSE: 4503, President and CEO: Naoki Okamura, "Astellas"] and Audax Biosciences Pty Ltd ("Audax")  announced that they have entered into an exclusive option and license agreement for DAX-044, Audax's lead immuno-oncology AVIKINE^® candidate. Under the agreement, Astellas receives an exclusive option which, on exercise, will grant Astellas a worldwide license to develop, manufacture and commercialize DAX-044. Audax has the option to co-fund and co-promote DAX-044 in Australia and New Zealand. The agreement further strengthens Astellas' pipeline in Immuno-Oncology, one of the Primary Focuses of Astellas' R&D strategy and complements its portfolio of targeted immunotherapy approaches.

Takahiko Iwaya, Chief Strategy Officer, Astellas

"At Astellas, we are committed to advancing innovative approaches that have the potential to address significant unmet needs for patients with cancer. DAX-044 is a promising investigational immuno-oncology program with a differentiated mechanism designed to selectively activate anti-tumor immune responses. By combining Audax's innovative science with Astellas' development, manufacturing and commercialization expertise, we hope to advance a potential new treatment option for patients with solid tumors, including cancers where effective immune stimulation remains an important therapeutic challenge."

Jai Rautela, Ph.D., MBA, Chief Executive Officer, Audax Biosciences

"Astellas shares our pioneering spirit in immuno-oncology making them an ideal partner for highly differentiated programs such as DAX-044. This partnership will expedite the planned phase 1 clinical evaluation of DAX-044 for the benefit of patients with various types of solid tumor. This transaction demonstrates confidence in our approach to novel therapeutic development and potential in co-developing DAX-044 in our home market."

DAX-044 is an investigational, immune-targeted interleukin-12 (IL-12) antibody-cytokine fusion, designed with AVIKINE® technology to concentrate IL-12's immune-activating activity within the tumor microenvironment while limiting the systemic toxicity that has historically constrained IL-12-based therapy. DAX-044 has demonstrated a potential best-in-class therapeutic index for an IL-12 agent in preclinical studies and is currently in IND/CTN-enabling development.

Under the terms of the agreement, Audax will receive up front and potential future option exercise payment totaling US$285 million and continue development of DAX-044 into a Phase 1 study expected to commence in 2027. Upon exercising its option, Astellas will assume sole responsibility for global development, manufacturing and commercialization, with Audax having the option to co-fund and co-promote DAX-044 in Australia and New Zealand. In addition, Audax will be eligible to receive development and commercial milestone payments of up to US$1.05 billion, as well as tiered double-digit royalties on worldwide net sales of DAX-044, if approved. Exercise of the option is subject to customary conditions, including receipt of applicable antitrust clearances.