Part B of the DIONE-01 study will look at whether IOA-244 increases anti-tumor responses in expansion groups of patients.
In early November, iOnctura SA announced it has fully enrolled an expansion group of patients with metastatic uveal melanoma in the DIONE-01 study. The trial is focused on examining the selective PI3Kδ inhibitor IOA-244.
The study is comprised of two parts, with part A being complete. In part A, the researchers analyzed the safety, tolerability and dosage of IOA-244 in patients. Part B will look at expansion groups of patients with different tumor types, including those within the metastatic uveal melanoma group. It will determine whether IOA-244 increases anti-tumor immune responses in patients – as monotherapy or in combination with pemetrexed/cisplatin and an immune checkpoint inhibitor.
Up to 182 patients with uveal melanoma, cutaneous melanoma, non-small cell lung cancer, mesothelioma, myelofibrosis or non-Hodgkin lymphoma will be enrolled. There will be up to 26 patients with metastatic uveal melanoma recruited to determine monotherapy activity of IOA-244.
“iOnctura is entering a highly exciting phase as it progresses two tumor-stroma-immune interface targeting programs through clinical development. IOA-244 continues to demonstrate an unprecedented clinical profile among PI3Kδ inhibitors,” said Catherine Pickering, CEO of iOnctura, in a release.
“iOnctura is moving rapidly in the use of IOA-244 to treat a range of solid tumor types including metastatic uveal melanoma, an underserved cancer with no currently approved drug treatments and poor patient outcomes,” she added. “We look forward to releasing early data from our preclinical and clinical evaluations of this exceptional molecule at ESMO IO.”
Data is expected to be released mid-2022, with final data planned for the end of 2022.
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