iOnctura Launches Phase II Study for Roginolisib in Cancer

iOnctura Begins Promising Phase II Study for Roginolisib

iOnctura, a pioneering clinical-stage biopharmaceutical company dedicated to tackling neglected and challenging cancers, has commenced the dosing of the first patient in its randomized Phase II OCULE-01 study. This significant investigation focuses on roginolisib, which is an innovative allosteric modulator of PI3K?, specifically targeting metastatic uveal melanoma, a rare yet aggressive form of eye cancer.

Overview of Roginolisib

Roginolisib represents a breakthrough in treatment options. As an orally ingested small molecule, it is designed to selectively inhibit PI3K? without the adverse side effects commonly associated with prior therapies. This cutting-edge approach has demonstrated a robust safety profile while significantly improving overall survival rates in patients suffering from this rare cancer during earlier studies.

Recent Developments and Designations

Recently, the European Medicines Agency (EMA) granted Orphan Drug Designation for roginolisib, which is a notable achievement. This designation allows for up to ten years of market exclusivity in the European Union, providing essential support for iOnctura’s mission to bring new hope to patients with limited treatment options.

The Phase II OCULE-01 study aims to assess the efficacy of roginolisib as a standalone treatment. It will include multiple sites across Europe and the United States, with plans to enroll approximately 85 patients who have shown progression after at least one prior therapy. The primary goal is to evaluate the overall survival rates of these participants.

Furthermore, the study has secondary objectives that will measure various important factors such as progression-free survival, objective response rates, and overall health-related quality of life among patients involved.

Encouraging Study Results

The initial results for roginolisib during the Phase I DIONE-01 study were very promising, indicating a substantial doubling of survival rates when compared to historical controls. Such results highlight the significant potential of this treatment in a cancer market that is expecting rapid growth, potentially reaching USD 9.56 billion by 2032.

Furthermore, important discussions are taking place within the medical community regarding the drug's impressive tolerability and the evidence presented by key investigators in the field.

Expert Opinions on Roginolisib

Principal Investigator of the Phase II OCULE-01 study, Paul Nathan, remarked on the impressive outcomes of roginolisib, highlighting the median survival of 16 months for patients who had exhausted previous systemic therapies. The enthusiasm surrounding its safety profile and results from early studies has sparked a forward momentum in further investigation.

Catherine Pickering, CEO and co-founder of iOnctura, expressed excitement about achieving this milestone. She stated that they are eager to explore roginolisib’s potential across a wider array of cancer indications, including but not limited to non-small cell lung cancer and myelofibrosis.

About iOnctura

iOnctura is reshaping the landscape for how neglected and hard-to-treat cancers are approached with its pipeline of first-in-class small molecules. By focusing on precision oncology, the company is making strides towards extending not only lives but also health spans for patients and their families. The company operates from its headquarters in Amsterdam, The Netherlands, and maintains a Swiss subsidiary in Geneva.

Roginolisib continues to emerge as a key asset for the firm as it strives to validate its full potential across various stages of clinical development, specifically within solid and hematological malignancies. With an emphasis on innovative treatment modalities, iOnctura is backed by prominent institutional investors, reinforcing its mission to pioneer advancements in cancer therapy.

Frequently Asked Questions

What is the Phase II OCULE-01 study?

The Phase II OCULE-01 study is a clinical trial aimed at evaluating the efficacy of roginolisib in treating metastatic uveal melanoma, focusing on patient survival metrics.

What is roginolisib?

Roginolisib is an allosteric modulator of PI3K? designed to treat various cancers, particularly effective in uveal melanoma with a favorable safety profile.

What are the objectives of the OCULE-01 study?

The primary objective is to evaluate overall survival in patients, while secondary objectives include assessing progression-free survival and quality of life.

What recent designations has roginolisib received?

Roginolisib has received Orphan Drug Designation from the EMA, offering multiple benefits including market exclusivity for treating rare diseases.

When did iOnctura begin the study?

The study started with the dosing of the first patient in March 2025, marking a significant milestone for iOnctura’s research efforts.

About The Author

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