iOnctura Announces FDA Clearance of IND Application for Roginolisib, a First-in-class Allosteric Modulator of PI3Kδ

iOnctura, a clinical-stage biotech developing selective cancer therapies against targets that play critical roles in multiple tumor survival pathways, today announces that the US Food and Drug Administration (FDA) has granted permission to proceed with clinical investigations of roginolisib in the United States of America.

Roginolisib (IOA-244) is in development for solid and hematologic malignancies including uveal melanoma, a rare cancer in which malignant (cancer) cells form in the uveal tract of the eye. When the cancer metastases, which it does in approximately 50% of patients, there are limited treatment options and projected overall survival is only a year.

As the first novel allosteric modulator of PI3Kδ, roginolisib marks a new era in drug development within the class. The unique binding mode, combined with high selectivity for PI3Kδ, is expected to translate to an improved safety and tolerability profile relative to that of earlier generation inhibitors.

“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” said Catherine Pickering, Chief Executive Officer of iOnctura. “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.”

Roginolisib is being investigated in the DIONE-01 trial, a two-part, first-in-human Phase I study (, identifier NCT04328844). The study is fully enrolled with final data expected Q1 2024. Across all patients treated to date, roginolisib monotherapy has shown 7% Grade 3/4 toxicities, with no dose limiting toxicities, drug-related serious adverse event (SAE) or drug related adverse event (AE) leading to dose interruption or discontinuation. Whilst median Overall Survival has not yet been reached, 62% of patients were alive at 12 months, which compares favourably to historical controls of 34% in the same setting[1].

Long-term administration of roginolisib is well tolerated and patients have been treated for up to 40 months in the study. Promising clinical activity has been observed across patients with both solid and hematological cancers.

[1] Rantala et al., Melanoma Res. 2019 Dec;29(6):561-568

Medical Device News Magazine
Our publication is dedicated to bringing our readers the latest medical device news. We are proud to boast that our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall purpose and objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.


QScout ™ is the first hematology platform designed for simple, fast operation at the point-of-care. It provides lab-grade, patient-side results that caregivers use to screen for health conditions including infection, leukemia, and other blood-related cancers, allergies, and many more.
The BD MiniDraw™ Capillary Blood Collection System is less invasive than a traditional venous blood draw by using capillary blood collected from a patient's finger by a trained healthcare worker, without the need for a phlebotomist to collect blood from a vein.
"Receiving this first FDA clearance for our retinal camera is not just a milestone, it's a leap forward in our quest to safeguard the vision of millions," said Dr. Patrick Sauvageau, optometrist, CEO, and co-founder of Zilia. "We're now focused on obtaining De Novo classification for ocular oximetry, a breakthrough biomarker that promises to revolutionize how we diagnose and manage a variety of ocular conditions."
The recent FDA clearances included Brainomix 360 e-CTP and Brainomix 360 e-MRI, both software modules that can support thrombolysis and thrombectomy treatment decisions, particularly for late-window patients who present to hospital more than 6-12 hours after stroke onset.
IONIC Health’s 510(k)-pending nCommand Lite technology is designed to include vendor-agnostic remote scanning capabilities. This strategic collaboration’s goal is to enable GE HealthCare to provide a multi-vendor, multi-modality remote scanning solution to healthcare systems and patients around the globe.

By using this website you agree to accept Medical Device News Magazine Privacy Policy