The FDA granted orphan drug designation to IOA-244 for the treatment of uveal melanoma, according to a press release from iOnctura.
IOA-244 (roginolisib), a PI3K-delta inhibitor, is currently being assessed in the two-part phase 1 DIONE-01 trial, with part A investigating the safety and pharmacokinetics of continuous daily dosing of the drug at 10 mg, 20 mg, 40 mg and 80 mg and part B investigating the efficacy of the biologically effective dose of 80 mg in other malignancies, including non-Hodgkin’s lymphoma.
Twenty-three patients with metastatic uveal melanoma and eight (Read more...)