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Elevation Oncology Licenses ADC-Targeting Claudin18.2 for Development in Solid Tumors

NEW YORK – Elevation Oncology said Thursday that it has signed an exclusive license agreement with CSPC Megalith Biopharmaceutical to develop and commercialize EO-3021 outside of mainland China, Hong Kong, Macau, and Taiwan.

In exchange for development rights in those countries, New York-based Elevation will make an upfront payment of $27 million to CSPC, which is headquartered in Shijiazhuang, China. CSPC will also be eligible to receive up to $148 million in development and regulatory milestone payments, and up to $1 billion in commercial milestone payments plus royalties on net sales.

To support the licensing of EO-3021, Elevation has secured a $50 million loan from K2 HealthVentures. The loan will be disbursed in two tranches. An initial tranche of $30 million is available immediately, and a second tranche of $20 million will be available in the future subject to the terms of an agreement between Elevation and K2.

Originally designated SYSA1801, EO-3021 is an antibody-drug conjugate designed to deliver a monomethyl auristatin payload. Its target, Claudin18.2, is a protein expressed in several types of solid tumors such as gastric, gastroesophageal junction, and pancreatic cancers.

CSPC is currently testing EO-3021 in a Phase I dose-escalation trial in China. Elevation plans to begin its own Phase I trial of the drug in the US in 2023.

"High Claudin18.2 expression is associated particularly with gastrointestinal cancers, but can also frequently be found in lung, breast, and liver cancer, representing an attractive commercial market opportunity," Elevation CSO David Dornan said in a statement. "The targeting of Claudin18.2 with EO-3021 could have a transformative role in addressing the unmet medical need in patients whose tumors express Claudin18.2."

Elevation is also developing seribantumab as a treatment for tumors driven by NRG1 fusions. Last month at the annual meeting of the American Society of Clinical Oncology, Elevation reported initial efficacy data from the Phase II CRESTONE trial for patients with solid tumors bearing an NRG1 gene fusion showing that 33 percent of 12 participants responded to the drug.