iOnctura Secures €80 Million Series B to Advance PI3Kδ Cancer Therapy Through Phase II Trials
Key Insights
iOnctura (search) raised €80 million in Series B financing led by Syncona (search) to advance its pipeline of oral cancer treatments targeting neglected and hard-to-treat cancers.
Lead asset roginolisib, the first allosteric modulator of PI3Kδ (search), demonstrated promising efficacy in uveal melanoma (search) with 70% overall survival rate and minimal toxicity in Phase I trials.
The funding will accelerate Phase II trials for roginolisib in uveal melanoma (search) and expand development into non-small cell lung cancer (search) and primary myelofibrosis (search) starting late 2024.
Swiss clinical-stage biopharmaceutical company iOnctura (search) announced the completion of an €80 million Series B financing round to advance its pipeline of precision oral cancer treatments targeting neglected and hard-to-treat malignancies. The funding round was led by new investor Syncona (search) Limited, with participation from the European Innovation Council Fund and existing investors including M Ventures, Inkef Capital, VI Partners, Schroders Capital, and 3B Future Health Fund.
Lead Asset Shows Promise in Rare Eye Cancer
The financing will primarily accelerate development of roginolisib, iOnctura (search)'s lead therapeutic candidate and the first allosteric modulator of PI3Kδ (search). This novel compound features a unique chemical structure and binding mode, targeting indications characterized by immune-mediated resistance and high PI3Kδ expression in both cancer cells and tumor-infiltrating immune cells.
In Phase Ib clinical trials for uveal melanoma (search), a rare cancer of the eye with limited treatment options, roginolisib demonstrated compelling efficacy and safety data. Among 23 metastatic uveal melanoma patients treated with 80mg roginolisib, less than 5% experienced Grade 3 or 4 toxicities. The therapy achieved a 70% overall survival rate, with median overall survival not yet reached, indicating sustained clinical activity over extended periods.
"This financing is validation of iOnctura (search)'s approach to developing precision cancer treatments with maximum clinical impact," said Catherine Pickering, Chief Executive Officer of iOnctura. "These therapies have the potential to significantly prolong the healthspan of patients suffering with neglected cancer types, such as uveal melanoma (search)."
Addressing PI3K Pathway Challenges
The PI3K signaling pathway represents one of the most commonly dysregulated pathways in cancer, yet previous attempts to target this pathway have faced significant safety challenges. The FDA's Oncologic Drugs Advisory Committee unanimously recommended in 2022 that future approvals of PI3K inhibitors for hematologic malignancies be supported by randomized trial data, citing high levels of fatal adverse events and toxicity rates associated with the drug class.
Roginolisib's allosteric modulation approach appears to overcome these limitations, delivering substantial anti-tumor effects with a low-toxicity profile. The compound has treated over 48 patients to date across solid and hematological malignancies, demonstrating what the company describes as an "unprecedented and first-in-class clinical profile."
Expansion Into Multiple Cancer Types
The eye melanoma market represents a rapidly growing opportunity, projected to reach $9.56 billion by 2032 according to Emergen Research. Building on the successful uveal melanoma (search) data and supported by a comprehensive preclinical data package, iOnctura (search) plans to commence trials in additional cancer indications later in 2024, including non-small cell lung cancer (search) and primary myelofibrosis (search).
Roginolisib received orphan drug designation from the FDA in January, recognizing its potential to address unmet medical needs in rare diseases.
Second Asset Targets Fibrotic Tumors
iOnctura (search)'s second clinical asset, cambritaxestat, represents the only autotaxin inhibitor in clinical development for cancer treatment. This first-in-class compound demonstrates excellent potency and specificity, targeting highly fibrotic tumors that overexpress autotaxin. Preclinical studies have shown cambritaxestat's ability to inhibit cancer cell growth and proliferation, stimulate immune cell infiltration, and prevent fibrosis development.
A Phase Ib study evaluating cambritaxestat in combination with chemotherapy for metastatic pancreatic cancer (search) is currently ongoing, with the primary endpoint measuring treatment-emergent side effects over one year.
Strategic Investment Partnership
Syncona (search) invested €30 million for a 23% stake in iOnctura (search), reflecting confidence in the company's clinical strategy and pipeline potential. Roel Bulthuis, Managing Partner and Head of Investments at Syncona, emphasized the strategic significance of the investment.
"iOnctura (search) represents a compelling opportunity to invest in a clinical-stage company and take a promising lead programme through to late-stage development," Bulthuis stated. "By allosterically modulating PI3Kδ (search), iOnctura has achieved a new level of precision and could be the first company to develop a clinically meaningful medicine targeting this pathway."
The company plans to initiate randomized Phase II trials for roginolisib starting in late 2024, marking a critical milestone in advancing these novel cancer therapies toward potential regulatory approval and commercial availability for patients with limited treatment options.