iOnctura’s COO Michelle Tsai shares her perspective on why she believes now is the right time for iOnctura to expand roginolisib’s clinical trial program to the US.
On September 9, 2025, iOnctura announced the expansion of roginolisib trials to the US, advancing a multi-indication strategy in oncology.
Q.
How is iOnctura expanding its roginolisib clinical trial program?
We announced this week that we have expanded our clinical trial program for roginolisib. US sites are now up and running , recruiting eligible patients with uveal melanoma as part of our global roginolisib trial called OCULE-01. This is an important trial and possible treatment for patients for patients with uveal melanoma as right now, their treatment options are limited. In addition, we are excited to announce that Dr. Jennifer Brown from Dana-Farber has initiated a trial that explores the role of roginolisib in the treatment of patients with Chronic Lymphocytic Leukemia.
Q.
Why is iOnctura expanding its clinical trial program for roginolisib into the US now?
Our journey and scientific exploration to combat neglected and hard-to-treat cancers has been years in the making. As we share more about the potential of roginolisib, we have had enthusiastic responses from US investigators, leading research centers, and patient communities. The US has a very engaged cancer patient community which translates to a broad awareness and interest in clinical trial participation. Certainly, we hope that we can bring roginolisib to patients in the US and the first step of that journey is generating the evidence there.
As someone who’s family member participated in a clinical trial, with cancer, I know how important hope and potential new treatment options are to families and patients with a cancer diagnosis.
Q.
Beyond clinical trials, what other factors influenced your decision?
Expanding in the US enables deeper collaboration with patient advocacy groups, health systems, and investors who are actively shaping the future of oncology care.
It also gives us the opportunity to engage with diverse populations and amplifying our mission to make complex science accessible and compelling.
