BOSTON, June 22, 2022 (GLOBE NEWSWIRE) — Ikena Oncology, Inc. (Nasdaq: IKNA, “Ikena”), a targeted oncology company forging new territory in patient-directed cancer treatment, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for IK-930, the Company’s novel TEAD inhibitor targeting the Hippo signaling pathway, in patients with unresectable NF2-deficient malignant pleural mesothelioma (MPM).
Fast Track designation granted by FDA 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.
“We are delighted to announce that IK-930 has been granted Fast Track designation, demonstrating the potential of IK-930 to address the unmet medical need of people with unresectable NF2-deficient MPM,” said Sergio Santillana, MD, Chief Medical Officer at Ikena. “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.”