Uveal melanoma treatment receives orphan drug designation
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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.
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Twenty-three patients with metastatic uveal melanoma and eight patients with follicular lymphoma have been treated with IOA-244 as of December 2022, with the inhibitor showing less than 5% grade 3 or grade 4 toxicities, all reportedly transient, across all patients.
Additionally, long-term administration of IOA-244 for more than 6 months has been well tolerated.
“These data demonstrate for the first time that a semi-allosteric inhibitor of [PI3K-delta] can be given to patients safely for long durations with no serious adverse events,” Catherine Pickering, CEO of iOnctura, said in the release. “We are excited to take IOA-244 forwards into a monotherapy registration study in uveal melanoma and to further explore its potential both in lymphoma and solid tumors such as [non-small cell lung cancer].”
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