FDA Grants Fast Track Status to Novel Therapy for Patients with Unresectable NF2-Deficient Malignant Pleural Mesothelioma

The U.S. Food and Drug Administration (FDA) has designated Fast Track status to a new therapeutic drug therapy for the treatment of malignant pleural mesothelioma (MPM) in patients with unresectable NF2-deficient tumors. The drug, IK-930, was granted Orphan Drug designation by the FDA earlier this year.

IK-930 was developed by Ikena Oncology, Inc. as a TEAD inhibitor that targets the Hippo signaling transduction pathway (HSTP) to disrupt gene and protein function in NF2-deficient tumor cancers to slow or halt cancer growth. It is estimated that 40% of mesothelioma cases are NF2-deficient.

IK-930 is to be administered as an oral therapy as a monotherapy for MPM and is also being researched in Phase 1 clinical trials in the treatment of a variety of cancers with mutations in the HSTP including non-small cell lung cancer, soft tissue sarcoma and other cancers that are NF2 deficient or express YAP1 or TAZ gene fusions.

For more information on the Phase 1 Clinical Trial for IK-930 visit ClinicalTrials.gov.

Also, please visit Ikena Oncology’s June 22 press release and the National Library of Medicine.