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05.01.2023 - 09:02:52

iOnctura provides development update on first-in-class semi-allosteric PI3KD inhibitor program

Updated clinical data demonstrates a prolonged and sustained favorable safety profile for roginolisib (IOA-244)Clinical data shows a comparable safety profile in both solid and hematologic malignanciesClinical responses seen in both solid and hematologic malignanciesUS FDA grants Orphan Drug Designation for IOA-244 in uveal melanomais a clinical-stage biotech developing selective cancer therapies against targets that play critical roles in multiple tumor survival pathways such as cellular proliferation; escape from immune detection; and drug resistance. iOnctura's pioneering approach to drug development is expected to offer significant clinical benefits over the traditional approach of targeting a single pathway alone. iOnctura has progressed two therapeutic candidates into mid-stage clinical development: IOA-244, a first-in-class semi-allosteric inhibitor of PI3K?; and IOA-289, a highly-selective, non-competitive autotaxin (ATX) inhibitor. iOnctura is backed by specialist institutional investors including M Ventures, Inkef Capital, VI Partners, Schroders Capital, and 3B Future Health Fund. iOnctura BV is headquartered in Amsterdam, The Netherlands with its wholly owned Swiss subsidiary, iOnctura SA, located in Geneva, Switzerland.

About IOA-244

IOA-244 is a first-in-class semi-allosteric, non-ATP competitive, small molecule PI3K? inhibitor. Its unique structural and selectivity features drive a unique way of inhibiting PI3K? which translates into a highly beneficial tolerability and clinical benefit profile. PI3K? over-expression stimulates multiple cancer mechanisms and has an oncogenic role in many tumor types. IOA-244 has a multi-modal effect on cancer; directly preventing cancer cell proliferation, harnessing an anti-tumor immune response via an effect on regulatory T-cells and cytotoxic T cells and potentiating the effect of immunotherapy. IOA-244 is currently in the cohort expansion phase of the DIONE-01 trial, a two-part, first-in-human dose study evaluating IOA-244 in advanced cancers and as a combination partner for conventional and immune- therapies (NCT04328844).

Uveal melanoma

Uveal melanoma (UM) is a rare malignancy arising within the uveal tract of the eye. There are approximately 7,000 newly diagnosed cases of uveal melanoma each year (around 2,000 in the United States). Over 50% of patients will progress to metastatic disease. Median overall survival for metastatic patients refractory to immunotherapy, the population included in the DIONE-01 trial, is approximately seven months.

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