Ikena Oncology has shared that on December 14th, 2023, the Food and Drug Administration (FDA) granted Orphan Drug Designation to IK-930 for the treatment of epithelioid hemangioendothelioma (EHE). We are excited about this designation following initial positive data from the IK-930 Phase I clinical trial published in Ikena’s November 9th press release.

What does this mean for EHE patients?

Orphan Drug Designation for IK-930 gives us a strong signal that the development of the drug is on track. While we still have a long way to go, this is a positive step toward having an FDA-approved therapy to treat EHE. The FDA grants Orphan Drug Designation to incentivize companies like Ikena to continue the development of a drug for a small patient population.

What is IK-930?

IK-930 is a novel TEAD inhibitor targeting the Hippo signaling pathway that binds to TEAD and prevents transcription of multiple genes that drive cancer progression. The Phase I study investigates IK-930 in patients with advanced solid tumors, including EHE.

Can I participate in the IK-930 clinical trial?

Phase I trials are conducted primarily to determine a new drug’s safety and dose range. If you are interested in participating in the IK-930 Phase I trial, talk to your physician. The centers listed below are enrolling EHE patients, and we’ll post information on additional locations as they open. 

IK-930 Phase I trial centers enrolling EHE patients:

• – Massachusetts General Hospital – Boston, MA – Dr. Greg Cote
• – MD Anderson Cancer Center – Houston, TX – Dr. Vinod Ravi
• – Memorial Sloan Kettering Cancer Center – New York, NY – Dr. Mrinal Gounder

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To learn more about the IK-930 Phase I trial and find contact information for these centers, visit ClinicalTrials.gov.

For more information, visit our Clinical Trials page or contact us at 877-760-4240 (toll-free in the US).