CEO Catherine Pickering reflects on 2024 and looks ahead to 2025
2024 has been a transformational year for iOnctura with a number of significant milestones achieved, which are a testament to the dedication and passion of our stellar team.
The highlight of 2024 was our €86 million Series B financing, which will fund the clinical trials for our pipeline of precision, oral, cancer treatments, including our lead asset roginolisib. Led by new investor Syncona, with participation by the EIC Fund, the venture arm of the European Innovation Council (EIC), and XGEN Venture, the round also included our existing investors M Ventures, Inkef Capital, VI Partners, Schroders Capital and 3B Future Health Fund. Our strong investor syndicate supports our commitment to extend lives and improve healthspans of patients through the development of bold and innovative treatments.
The financing has been vital in accelerating the development of our lead asset roginolisib, a first-in-class allosteric modulator of PI3Kδ, for the treatment of uveal melanoma and a number of other oncology indications. In December, we announced positive data from our completed Phase I study demonstrating that roginolisib is safe at the biologically effective dose for up to 4.5 years of treatment. This safety profile is unprecedented in the PI3Kδ class and results from the completely novel allosteric binding mechanism. Encouragingly, we saw a doubling of overall survival in our uveal melanoma patients compared to historical controls. Following these positive data we are excited to see how the drug performs in a randomized Phase II trial. Trial sites are in the process of being activated for this study, OCULE-01.
With the funding in place from our Series B financing round, I’m hugely excited about the possibilities for 2025 as our drugs move through the development pipeline and closer to improving outcomes for cancer patients.
We also expanded the development of the roginolisib clinical trial program to other indications including non-small cell lung cancer (NSCLC), via a clinical collaboration agreements with GSK, and myelofibrosis. We look forward to starting Phase II studies in both these indications in early 2025.
This year also saw the FDA grant Orphan Drug Designation (ODD) for our first-in-class autotaxin cancer therapy, cambritaxestat. This is testament to the exciting potential this drug holds for metastatic pancreatic cancer where it is being combined with standard of care nab-paclitaxel and gemcitabine in the Phase I AION-02 study. In a recent thought leadership article, iOnctura outlined its commitment to scientific advances in pancreatic cancer and the exploration of novel combinations with cambritaxestat, the only autotaxin inhibitor in clinical development for cancer.
Our progress has not gone unnoticed – in November, iOnctura was shortlisted for the European Lifestars Awards for Biotech of the Year and Series B Raise of the Year, and was also shortlisted at the prestigious Scrip Awards for both Best Oncology R&D Advance and also Executive of the Year – Clinical-Stage Companies.
We have had several papers published, validating our research: our CMO Michael Lahn contributed to research published in the October edition of the European Journal of Cancer, which further highlighted the role of autotaxin in GI tumors. November also saw the publication of research in AACR Molecular Cancer Therapeutics of our research, completed in partnership with Cancer Research UK (CRUK) and the group of Stuart Farrow, which confirms the critical role of autotaxin in promoting a microenvironment favourable to tumor growth in pancreatic cancer. Other highlights included a poster presentation at ENA 2024 by Chiara Tarantelli, from the laboratory of our collaborator Francesco Bertoni, which identified genes modulating lymphoma cells response to roginolisib.
In 2025 we look forward to progressing our lead asset, roginolisib, through Phase II trials in uveal melanoma, a neglected cancer type with few available treatments, and other oncology indications.
We would like to thank the patients and families who have been part of our clinical trials. Through our advancements in the clinic, we seek to extend the healthspan of patients and provide much needed treatments to those suffering from neglected and hard-to-treat cancers.
