With fresh €80M in hand, iOnctura looks to chart new PI3K path
20 Jun 2024
Phase 1Phase 2Clinical Result
Shaking off the baggage that has weighed down the PI3K class, iOnctura announced Thursday that it secured €80 million ($86 million) in a series B round to help move its lead asset roginolisib – an allosteric modulator of PI3Kδ that could offer more selective targeting and possibly a cleaner safety profile – into Phase II.
The fundraise was led by new investor Syncona and joined by the European Innovation Council (EIC) Fund. "To date, no company has been able to successfully target this well-known cancer pathway with sufficient precision," commented Roel Bulthuis, head of investments at Syncona, adding iOnctura "could be the first company to develop a clinically meaningful medicine targeting this pathway."
Existing backers such as M Ventures, Inkef Capital, VI Partners, Schroders Capital and 3B Future Health Fund also contributed.
A class with baggage
The PI3K class, well known for its toxic side effects when used to treat blood cancers, has faced a wave of market withdrawals in recent years due to a combination of poor tolerability, modest efficacy and competitive pressures. In 2022, the FDA convened an advisory panel that voted in favour of requiring future approvals of PI3K inhibitors to be supported by randomised trial data with active comparator arms, rather than the single-arm studies on which early PI3K drug approvals had been based.
"Roginolisib is very different from what's gone before," iOnctura CEO Catherine Pickering told FirstWord. It targets PI3Kδ "in an allosteric way, which translates to precision targeting of PI3Kδ only," she said, adding, "we are on target at the maximum… [without inhibiting] anything else in our patients."
The company says the compound has demonstrated an "unprecedented" clinical profile in solid and haematological malignancies, with over 48 patients treated to date. According to Pickering, the precision targeting has led to a favourable safety profile, with no dose interruptions or significant adverse events typically associated with PI3Kδ inhibition. "We see minor Grade 1 and one or two Grade 2 side effects, but nothing to speak of," she said, adding that the company will be publishing the data in the coming weeks.
Phase II-bound this year
The series B financing will accelerate development of roginolisib in its lead indication of uveal melanoma, where a Phase Ib study demonstrated sustained clinical activity "over many months" in this setting. The company said Phase II testing in that disease setting is set to begin in late 2024, as well as in non-small-cell lung cancer and primary myelofibrosis. Pickering suggested the mid-stage uveal study may even potentially support an accelerated approval.
Second project
Meanwhile, iOnctura’ssecond clinical asset, cambritaxestat, is an autotaxin inhibitorautotaxin inhibitor in clinical development for cancer. The candidate, which was brought in from Cancer Research UK as a discovery-stage project, is being developed for highly fibrotic tumours that overexpress autotaxin. A Phase Ib study in combination with chemotherapy in metastatic pancreatic cancer is ongoing.
Pickering highlighted the potential of cambritaxestat to break down the fibrotic stromal shell that "protects" tumours, but also its ability to aid immune cell penetration. "By inhibiting and taking down the levels of LPA (lysophosphatidic acid) in the tumour microenvironment – not only taking this fibrotic core away – you're also allowing immune cells to penetrate the tumour. So, it's more than just an anti-fibrotic," she explained.
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