Astellas Pharma and Evopoint Biosciences have entered into an exclusive license agreement for XNW27011, a novel investigational clinical-stage antibody-drug conjugate (ADC) targeting CLDN18.2.

The agreement grants Astellas a worldwide – excluding China's mainland, Hong Kong, Macao and Taiwan region, exclusive license to develop and commercialise XNW27011.

XNW27011 is currently being evaluated in a Phase 1/2 study in China in patients with CLDN18.2-expressing solid tumours, including gastric cancer, gastroesophageal cancer and pancreatic cancer. It uses a proprietary topoisomerase I inhibitor payload and linker technology, an approach that has demonstrated clinical success in other approved cancer therapies.

Astellas has significant expertise in developing therapies that target CLDN18.2, including VYLOYTM, the first CLDN18.2-targeted therapy approved in the world. XNW27011 has the potential to address currently unmet patient needs and will expand Astellas' oncology pipeline which currently contains CLDN-targeting therapies utilising different approaches, as well as ADCs directed to other targets.

Under the terms of the agreement, Evopoint will receive a USD 130 million upfront payment and is eligible to receive up to USD 70 million near-term payments, and additional milestone payments associated with development, regulatory and commercialisation milestones totalling up to USD 1.34 billion, as well as royalties on net sales of XNW27011, if approved.

Adam Pearson, Chief Strategy Officer, Astellas said, “Astellas is dedicated to advancing innovative therapies for some of the most challenging-to-treat cancers, such as gastric and pancreatic cancer. XNW27011 is a promising new asset that complements Astellas' pipeline and enhances our leading position in precision oncology. We look forward to harnessing our expertise in targeting CLDN18.2 and specialised knowledge in GI cancers to advance XNW27011 and deliver meaningful outcomes to patients.”

Arthur Qiang, Chairman, Evopoint remarked, “XNW27011 is a novel investigational antibody-drug conjugate that has shown great promise in the clinic. Astellas has a proven history of developing and commercializing a strong franchise of innovative cancer therapies. We are pleased to enter into this new license agreement to further our collective goals of bringing new treatment options for patients in need worldwide.”