Clinical-stage biotech iOnctura has received US Food and Drug Administration (FDA) clearance to carry out investigations into a treatment aimed at tackling rare cancers.

The FDA has granted its approval for the Swiss company to carry out clinical investigations into Roginolisib (IOA-244) as part of its investigational new drug (IND) application, which is aimed at treating conditions such as solid and haematologic malignancies, including uveal melanoma.

Uveal melanoma is a rare form of cancer in which malignant cells form in the uveal tract of the eye, which has an approximately 50% chance of metastasising leading to a projected survival of only a year in most cases.

According to iOnctura, the drug is the first novel allosteric modulator of PI3Kδ and boasts a unique binding mode and high selectivity for the offending molecule, which the company expects will improve safety and tolerability over previous treatments for the same indication.

Roginolisib is currently in a trial named DIONE-01 (NCT04328844), a two-part first-in-human Phase I study with final data expected to be published in the first quarter of 2024.

iOnctura has said regarding the DIONE-01 study that whilst median overall survival has not yet been reached, 62% of patients were alive at 12 months, comparing favourably to historical controls of 34% in the same setting.

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By GlobalData

iOnctura CEO Catherine Pickering said: “We believe roginolisib has the potential to slow or halt the progression of uveal melanoma, so providing an important treatment option for patients who currently have no approved therapeutic options after they progress on their first-line therapy.

“As we remain on track to deliver final clinical data from the initial patients treated with roginolisib in 2024, the clearance of our IND application demonstrates our commitment to driving roginolisib through the clinic.”

GlobalData estimates the overall market size for drugs aimed at treating uveal melanoma stood at around $147m by the end of 2022, which is expected to rise to $6,260m by the end of 2029.

GlobalData is the parent company of Clinical Trials Arena.