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iOnctura Unveils Promising Data on Cambritaxestat at ESMO 2025

iOnctura, a trailblazer in precision oncology, has taken a significant stride in the fight against pancreatic cancer by unveiling compelling clinical data for its novel drug cambritaxestat at the European Society for Medical Oncology (ESMO) Congress in Berlin, Germany. This groundbreaking study highlights the drug's remarkable ability to meet its primary endpoint when combined with standard chemotherapy, providing hope for patients battling this aggressive disease.

Overview of the Study

The Phase Ib study, known as AION-02, involved patients suffering from metastatic pancreatic ductal adenocarcinoma (mPDAC) who had not previously received treatment. Cambritaxestat, an autotaxin (ATX) inhibitor, was administered in conjunction with the chemotherapy regimen of gemcitabine and nab-paclitaxel (GnP). The research observed the drug's safety and its anti-tumor responses, marking a crucial development in a field characterized by limited treatment options.

Results and Findings

The trial's outcomes have been promising. Sixteen patients participated in the study, receiving various doses of cambritaxestat, ranging from 100 mg to 800 mg twice daily. The results indicated that the treatment was well-tolerated, with no dose-limiting toxicities reported. Moreover, no adverse events led to discontinuation or modification of the treatment regimen. The pharmacodynamic analysis revealed a dose-dependent decrease in relevant plasma lipid markers, confirming the drug's targeted effects against tumor growth. Notably, patients in the higher-dose group experienced significant and sustained reductions in the cancer marker CA19-9, correlating with positive radiographic responses and improved survival rates.

Dr. Davide Melisi, the lead investigator and Associate Professor of Medical Oncology at the University of Verona, expressed optimism about the findings. He noted that the observed clinical activity alongside a tolerable safety profile is particularly significant, given the aggressive nature of metastatic pancreatic cancer, which is marked by fibrosis and complex biological behavior.

The Path Forward

Dr. Michael Lahn, iOnctura’s Chief Medical Officer, reinforced the therapeutic potential of targeting the autotaxin pathway in overcoming the intricate biology of pancreatic cancer. He emphasized the importance of further exploration into autotaxin inhibition and is hopeful about the prospects for cambritaxestat as it progresses through clinical development. As the first autotaxin inhibitor studied in cancer patients, cambritaxestat represents a pioneering approach towards treating several cancer types characterized by high autotaxin expression.

As part of its ongoing commitment to innovation in cancer treatment, iOnctura is dedicated to enhancing patient outcomes through the development of its lead asset. The company is strategically focused on addressing the needs of patients with tough-to-treat cancers and is working on expanding the clinical trials for cambritaxestat.

About Cambritaxestat

Cambritaxestat distinguishes itself as a first-in-class autotaxin inhibitor, offering a unique mechanism of action by not only directly inhibiting tumor growth but also enhancing immune response and decreasing fibrosis. This multifaceted approach may improve medication and immune cell access to tumors, further supporting its development in clinical settings.

In recognition of its potential, cambritaxestat received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) in March 2024, underscoring its importance in addressing the urgent need for effective therapies for pancreatic cancer patients.

Conclusion

The data revealed at ESMO 2025 signifies a hopeful advancement in the treatment of metastatic pancreatic cancer. With continued support and scientific exploration, cambritaxestat may become a vital component in the arsenal against this life-threatening disease, paving the way for enhanced therapeutic options.