Astellas Pharma already has the first FDA approval for a therapy that goes after Claudin 18.2, a protein whose overexpression on the surface of cells in gastrointestinal cancers makes it an attractive drug target. But the company has shown interest in pursuing multiple ways to drug this target, and it’s furthering this strategy with a deal that secures rights to a clinical-stage molecule from Evopoint Biosciences.
Astellas’s approved drug, Vyloy, is a monoclonal antibody. The Japanese drugmaker is also developing a bispecific antibody that targets the gut protein, which is usually shortened to CLDN18.2. Evopoint’s drug candidate, XNW27011, is type of drug called an antibody drug conjugate (ADC).
Per deal terms announced late Thursday, Astellas has agreed to pay $130 million up front for rights to the Evopoint drug. Astellas said Evopoint’s drug fits its pipeline, which includes other approaches to CLDN as well as ADCs in development for other targets. XNW27011 is currently in Phase 1/2 testing in China, where Evopoint is based. The study is evaluating the drug in CLDN18.2-expressing solid tumors, including gastric cancer, gastroesophageal cancer, and pancreatic cancer.
Vyloy was approved last October for treating gastric or gastroesophageal junction (GEJ) adenocarcinoma that expresses CLDN18.2. While Astellas was first to win regulatory approval of a drug that goes after this protein, other companies remain in pursuit of that target. This potential competition includes ADCs. AstraZeneca’s ADC, code-named AZD0901, has reached Phase 3 testing in gastric and GEJ adenocarcinoma. Early this year, ArriVent Biopharma licensed a CLDN18.2-targeting ADC from Shanghai-based Lepu Biopharma. But some ADC efforts have come up short against this target. Elevation Oncology discontinued development of its CLDN18.2-targeting ADC in March due to disappointing Phase 1 results.
Astellas’s agreement with Evopoint gives the Japanese company global rights to XNW27011, excluding mainland China, Hong Kong, Macao, and Taiwan. Beyond the upfront payment, the deal puts Evopoint in line for up to $70 million in near-term payments. Milestone payments could bring the total to up to $1.34 billion. If Astellas is able to commercialize the ADC, the firm will also pay Evopoint royalties on sales of the drug.
“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,” Adam Pearson, Astellas’s chief strategy officer, said in a prepared statement .
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