iOnctura secures $86m for Phase II cancer trials

Swiss biopharmaceutical company iOnctura has successfully secured €80 million ($85.8 million) in Series B financing to advance the Phase II clinical trials for its leading cancer treatments, roginolisib and cambritaxestat. This significant funding round will enable the company to further investigate these therapies' potential in combating various forms of cancer.

Roginolisib is set to enter clinical trials targeting multiple cancer types, including non-small cell lung cancer (NSCLC) and primary myelofibrosis, later this year. This compound works as an allosteric modulator of phosphoinositide 3-kinase delta (PI3Kδ), an enzyme that triggers the growth and proliferation of white blood cells, thus inducing an immune response. PI3Kδ is notably overexpressed in various hematological cancers, where its heightened activity is linked to tumor progression and invasive potential. The significance of roginolisib is underscored by its recent designation as an orphan drug by the US Food and Drug Administration (FDA) in January.

However, the PI3K class of drugs has encountered regulatory hurdles. In 2022, the FDA’s Oncologic Drugs Advisory Committee (ODAC) recommended that future approvals for PI3K inhibitors in treating hematologic malignancies should be backed by randomized trial data. This advisory came in response to the high levels of fatal adverse events and considerable toxicity rates associated with this class of drugs.

Roginolisib is currently being evaluated in a Phase I clinical trial (NCT04328844) both as a monotherapy and in combination with chemotherapy for patients with advanced or metastatic cancers, including metastatic uveal melanoma—a rare eye cancer. Among the 23 patients with metastatic uveal melanoma treated with 80 mg of roginolisib, less than 5% experienced Grade 3 or 4 toxicities. The therapy has shown a notable overall survival rate of 70%, though the median overall survival has yet to be reached.

Cambritaxestat, another promising therapy from iOnctura, is an autotaxin inhibitor that modulates the secretion of extracellular lysophosphatidic acid, a molecule involved in various cell responses such as proliferation and apoptosis. This inhibitor is being developed to treat highly fibrotic tumors that overexpress autotaxin, including metastatic pancreatic cancer. The safety and pharmacokinetics of cambritaxestat are being tested in a Phase I/II study (NCT05586516) involving patients with metastatic pancreatic cancer. The primary endpoint of the trial is to monitor the incidence of treatment-emergent side effects over a year.

The Series B financing round saw participation from several prominent investors, including Syncona Limited, the EIC Fund (the venture arm of the European Innovation Council), Merck Ventures, Inkef Capital, VI Partners, Schroders Capital, and 3B Future Health Fund. Notably, Syncona was the major investor, contributing €30 million ($32.2 million) for a 23% stake in iOnctura.

In addition to its investment in iOnctura, Syncona has also invested £16.5 million ($21 million) for a 60.9% stake in Yellowstone, a University of Oxford spinout company. Yellowstone focuses on developing soluble bispecific T cell receptor-based therapeutics to treat acute myeloid leukemia, demonstrating Syncona's broader commitment to fostering innovative cancer treatments.