Astellas, Evopoint Ink Exclusive Deal for CLDN18.2-Targeting ADC XNW27011

Astellas Secures Global Rights to Evopoint’s Promising CLDN18.2-Targeting Antibody-Drug Conjugate XNW27011 in Strategic Oncology Expansion

In a strategic move that reinforces its commitment to precision oncology, Astellas Pharma Inc. has entered into an exclusive license agreement with Evopoint Biosciences Co., Ltd. for global rights to XNW27011, a novel investigational antibody-drug conjugate (ADC) that targets Claudin 18.2 (CLDN18.2)—a protein increasingly recognized for its role in gastrointestinal cancers. Announced jointly on May 30, 2025, the agreement signals a major step forward for both companies in the race to bring advanced therapies to patients battling aggressive, difficult-to-treat cancers.

A New Chapter in Targeted Oncology

Under the terms of the deal, Astellas will acquire exclusive rights to develop and commercialize XNW27011 outside of Greater China, which includes mainland China, Hong Kong, Macao, and Taiwan. Evopoint retains rights within this territory, where the therapy is already undergoing early clinical evaluation. The agreement positions Astellas to lead global development and marketing of the investigational ADC and is poised to significantly bolster its oncology pipeline.

Astellas has agreed to pay $130 million upfront, along with up to $70 million in near-term development milestones. In addition, Evopoint is eligible to receive up to $1.34 billion in further milestone payments based on developmental, regulatory, and commercial progress, plus tiered royalties on net sales should the drug be approved.

This deal reflects a broader industry trend of established pharmaceutical firms partnering with nimble biotech innovators to accelerate the development of first-in-class or best-in-class oncology therapies. For Astellas, it underscores a clear commitment to deepen its presence in the high-stakes field of antibody-drug conjugates—a class of therapies designed to combine the targeting ability of monoclonal antibodies with the cell-killing power of cytotoxic drugs.

The Science Behind XNW27011

XNW27011 is currently being tested in a Phase 1/2 clinical trial in China, enrolling patients with CLDN18.2-expressing solid tumors, including gastric cancer, gastroesophageal junction cancer, and pancreatic cancer—all malignancies known for their poor prognoses and limited treatment options. Early-phase studies are focused on evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of the drug in patients with advanced disease.

At the heart of XNW27011’s design is a proprietary topoisomerase I inhibitor payload linked to a CLDN18.2-targeting monoclonal antibody using novel linker technology. Topoisomerase I inhibitors work by interfering with DNA replication in cancer cells, ultimately leading to cell death. When delivered via ADC technology, these potent cytotoxins can be administered more precisely, limiting damage to healthy cells and potentially reducing side effects.

The use of topoisomerase I inhibitors in ADCs has gained traction in recent years due to the success of drugs like Enhertu (trastuzumab deruxtecan) and Trodelvy (sacituzumab govitecan). XNW27011 aims to follow a similar path by leveraging its precision targeting of CLDN18.2, which is overexpressed in certain gastrointestinal tumors but has limited expression in normal tissues, making it an ideal therapeutic target.

Building on a Legacy of CLDN18.2 Innovation

Astellas is no stranger to the CLDN18.2 space. The company has already developed VYLOY™ (zolbetuximab), the world’s first approved therapy specifically targeting CLDN18.2. VYLOY received regulatory clearance for the treatment of advanced gastric and gastroesophageal junction cancers, setting a precedent in the field and establishing Astellas as a pioneer in CLDN-targeted therapies.

With XNW27011, Astellas is now looking to expand its footprint in this domain by incorporating ADC technology into its CLDN-targeted portfolio. This marks a complementary approach to its current assets and could ultimately provide a broader range of treatment options for patients depending on tumor characteristics, disease stage, and prior lines of therapy.

Adam Pearson, Chief Strategy Officer at Astellas, emphasized the importance of the collaboration and how it aligns with the company’s broader mission.

“Astellas is dedicated to advancing innovative therapies for some of the most challenging-to-treat cancers, such as gastric and pancreatic cancer,” said Pearson. “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 specialized knowledge in GI cancers to advance XNW27011 and deliver meaningful outcomes to patients.”

Evopoint’s Vision for Global Impact

For Evopoint Biosciences, the agreement with Astellas represents a major validation of its ADC technology platform and drug development capabilities. Founded with a mission to leverage next-generation biotherapeutics in oncology, Evopoint has steadily built a portfolio of drug candidates aimed at addressing molecular targets with strong biological rationale.

Arthur Qiang, Chairman of Evopoint, highlighted the significance of the agreement and the value of collaborating with a global pharmaceutical partner.

“XNW27011 is a novel investigational antibody-drug conjugate that has shown great promise in the clinic,” Qiang said. “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.”

ADCs and the Future of Cancer Therapy

Antibody-drug conjugates are gaining prominence across the oncology landscape for their ability to selectively target tumor cells while minimizing collateral damage. These drugs represent a convergence of precision medicine and cytotoxic chemotherapy—fields that were once seen as separate approaches. As of 2025, more than a dozen ADCs have received FDA approval, with many more in various stages of development.

One of the key advantages of ADCs is their modularity: drug developers can combine different antibodies, linkers, and payloads to optimize efficacy and safety for specific cancer types. The inclusion of topoisomerase I inhibitors, in particular, is seen as a game-changing strategy that offers potent anti-tumor effects without some of the limitations seen in traditional chemotherapy.

With XNW27011, Astellas is not only expanding its clinical-stage pipeline but also making a bet on the continued momentum of ADCs in oncology. By aligning itself with Evopoint, a biotech with innovative capabilities in ADC engineering, Astellas gains access to a cutting-edge platform with long-term potential for pipeline expansion.

As clinical development of XNW27011 continues in China, Astellas is expected to initiate additional studies outside of Greater China, including in the U.S., Europe, and Japan. Regulatory interactions, including investigational new drug (IND) submissions and global clinical trial planning, will likely follow as Astellas seeks to establish XNW27011 as a core asset in its oncology strategy.

This collaboration also underscores the increasingly global nature of cancer drug development. With innovation emerging from biotech hubs around the world—whether in Asia, North America, or Europe—cross-border partnerships like this one are essential to accelerating timelines and expanding access to novel therapies.

Ultimately, for patients with advanced gastric, gastroesophageal, or pancreatic cancers, the clinical success of XNW27011 could provide a desperately needed new option—one grounded in the precision targeting of tumor biology and powered by cutting-edge ADC technology.

Source link

Newsletter Updates

Enter your email address below and subscribe to our newsletter