Rare Daily Staff

The U.S. Food and Drug Administration granted Ikena Oncology Fast Track designation for IK-930, the company’s experimental therapy for unresectable NF2-deficient malignant pleural mesothelioma.

Patients with NF2-deficient malignant pleural mesothelioma account for approximately 40 percent of mesothelioma patients worldwide and are generally treated through a combination of standard-of-care options, including surgery, chemotherapy, immunotherapy, and radiation.

IK-930 provides a novel targeted approach to address the underlying biology driven by the genetic alterations that cause cancer pathogenesis. IK-930 binds to TEAD transcription factors to prevent transcription of multiple genes in the Hippo pathway that are known to cause cancer progression.

IK-930 is currently being studied in a phase 1 clinical trial as a monotherapy in patients with advanced solid tumors with or without gene alterations in the Hippo pathway, including NF2-deficient malignant mesothelioma, Epithelial Hemangioendothelioma (EHE) with documented TAZ/CAMTA1 fusion genes, as well as other solid tumors with either NF2 deficiency or with YAP/TAZ genetic fusions. Preclinical and translational data shared at the American Association for Cancer Research 2022 Annual Meeting highlighted IK-930 as a potential first-in-class TEAD inhibitor that could address unmet need and overcome therapeutic resistance.

Fast Track designation facilitates the development and expedites the review of drugs intended to treat serious or life-threatening diseases. Features of Fast Track designation include opportunities for more frequent interactions with the FDA review team and, if supported by clinical data, the therapy could potentially be eligible for priority review. Earlier in 2022, the FDA granted IK-930 Orphan Drug designation, which supports development of drugs for rare disorders, as a potential novel therapeutic option for patients with malignant pleural mesothelioma.

“This milestone, combined with the Orphan Drug designation in mesothelioma, further validates our targeted oncology approach to address significant unmet medical needs for difficult-to-treat cancers and supports our goal to advance the development of IK-930 for the patients who potentially could benefit most,” said Sergio Santillana, chief medical officer at Ikena.

Photo: Sergio Santillana, chief medical officer at Ikena

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