On July 20, 2021 iOnctura SA, a clinical stage oncology company targeting core resistance and relapse mechanisms at the tumor-stroma-immune interface, reported the start of clinical development for its second program, a next generation autotaxin inhibitor designated IOA-289 (Press release, iOnctura, JUL 20, 2021, View Source [SID1234640246]). IOA-289 will be the first autotaxin inhibitor to be investigated in oncology.

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The Italian Medicines Agency (AIFA) has authorized a phase 1a dose-escalation study for IOA-289 in healthy volunteers. The healthy volunteer study prepares the way for a phase 1b trial of IOA-289, which iOnctura plans to conduct in patients with pancreatic cancer. iOnctura’s Phase Ib trial in pancreatic cancer is expected to begin in 2022.

"We are very excited to progress our highly differentiated autotaxin inhibitor, IOA-289, as our second clinical program," said Catherine Pickering, CEO of iOnctura. "This is another significant milestone for iOnctura demonstrating our strong development pipeline and capabilities of our team. We are looking forward to translating the promise demonstrated in our preclinical studies into humans."

In many types of cancer, including pancreatic cancer, high expression of autotaxin and the product it generates (lysophosphatidic acid – LPA) correlate with poor outcomes. IOA-289 has a unique chemistry and has demonstrated promising effects in several preclinical solid tumor models including pancreatic cancer. It has also exhibited greater potency and less toxicity than first-generation autotaxin inhibitors that have until now only been trialed in fibrotic disease indications.

The Phase 1a healthy volunteer study will involve a total of forty volunteers (2 receiving placebo, and 6 actively dosed in each of 5 dose escalation cohorts) and will explore a 10-fold dose-range of IOA-289. Topline data from the study are expected to be available in Q4 2021.

The short preparatory study in healthy volunteers will garner key information on the safety, pharmacokinetics and pharmacodynamics of IOA-289 enabling iOnctura to accelerate into a Phase 1b trial in pancreatic cancer.