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Ikena Oncology to Launch Trial of TEAD Inhibitor in Biomarker-Selected Cancers

NEW YORK – Ikena Oncology on Tuesday said the US Food and Drug Administration has cleared an investigational new drug application for its TEAD inhibitor IK-930, allowing it to begin evaluating the agent in cancer patients harboring genetic mutations in the Hippo signaling pathway.

Boston-based Ikena will launch a biomarker-guided Phase I trial of IK-930 in tumor types that have a high frequency of Hippo pathway alterations, including NF2-deficient malignant mesothelioma as well as certain soft tissue sarcomas with YAP/TAZ genetic fusions, such as epithelioid hemangioendothelioma. Additionally, Ikena will study the agent in combination with other targeted treatments in patients with solid tumors harboring EGFR and KRAS mutations.

IK-930 blocks TEAD-dependent transcription of genes that cause cancer progression, metastases, and treatment resistance. According to the firm, preclinical research supports further exploring the treatment as a monotherapy and in combination with targeted agents such as EGFR and MEK inhibitors.

"Our biomarker-driven approach will be key in determining which patient populations stand to benefit most from IK-930," Sergio Santillana, Ikena's chief medical officer, said in a statement.

Ikena will begin the Phase I trial in early 2022.