iOnctura announces EUR80 million Series B financing to progress pipeline through Phase II trials

• Led by new investor Syncona, with participation from the European Innovation Council Fund as well as existing investors
• To progress pipeline of innovative, first-in-class, oral cancer treatments targeting neglected and hard-to-treat cancers
• To accelerate development of lead asset roginolisib for treatment of uveal melanoma and a number of other oncology indications

GENEVA and AMSTERDAM, June 20, 2024 /PRNewswire/ -- iOnctura, a clinical-stage biopharmaceutical company combating neglected and hard-to-treat cancers, today announces that it has closed an EUR80 million Series B financing. The funding round was led by new investor Syncona Limited with participation by the EIC Fund, the venture arm of the European Innovation Council (EIC), as well as existing investors M Ventures, Inkef Capital, VI Partners, Schroders Capital and 3B Future Health Fund.

iOnctura is developing a portfolio of precision oral small molecules that target cancers in novel ways. The bold new treatments extend lives and improve healthspans, changing the outlook for patients and their families. The Company has progressed two therapeutic candidates into mid-stage clinical development.

Lead asset roginolisib is the first allosteric modulator of PI3Kδ, with a unique chemical structure and binding mode. It is being developed for indications burdened by immune mediated resistance and a high expression of PI3Kδ in cancer cells and tumor-infiltrating immune cells. Roginolisib has potential to become the first successful, clinically meaningful therapy to target the critical PI3Kδ cancer pathway. It has demonstrated an unprecedented and first-in-class clinical profile in solid and hematological malignancies, with over 48 patients treated to date. 

The financing will be used to accelerate development of roginolisib for the treatment of uveal melanoma (UM), a rare cancer of the eye with few available treatments. Eye melanoma is a rapidly growing market which is projected to be worth USD 9.56B by 2032^[1] . In a Phase Ib clinical trial, roginolisib demonstrated long-term safety and promising efficacy in UM with sustained clinical activity over many months. Full results will be announced in the coming months. 

The successful UM data reported so far, combined with a rich preclinical data package, supports the rationale to expand into other indications. iOnctura plans to commence trials in other cancer indications, including non-small cell lung cancer and primary myelofibrosis, later in 2024.

iOnctura's second clinical asset, cambritaxestat, is the only autotaxin inhibitor in clinical development to treat cancer. It has excellent potency and specificity, and is being developed for highly fibrotic tumors that overexpress autotaxin. A Phase Ib study of cambritaxestat in combination with chemotherapy in metastatic pancreatic cancer is ongoing.

Catherine Pickering, Chief Executive Officer, iOnctura, said: "This financing is validation of iOnctura's approach to developing precision cancer treatments with maximum clinical impact. These therapies have the potential to significantly prolong the healthspan of patients suffering with neglected cancer types, such as uveal melanoma. We are pleased to welcome our new investors Syncona and the EIC Fund alongside our existing strong syndicate. Their experience will be invaluable as we look to advance our pipeline and take iOnctura to its next stage of growth."

Roel Bulthuis, Managing Partner and Head of Investments at Syncona and Board member of iOnctura, added: "iOnctura represents a compelling opportunity to invest in line with our strategy and capital allocation focus in a clinical-stage company, and take a promising lead programme through to late-stage development. To date, no company has been able to successfully target this well-known cancer pathway with sufficient precision. By allosterically modulating PI3Kδ, iOnctura has achieved a new level of precision and could be the first company to develop a clinically meaningful medicine targeting this pathway. Its programmes have potential utility across a range of cancers, which we are supporting the company to unlock through a refined clinical strategy."

About iOnctura

iOnctura is a clinical-stage biopharmaceutical company combating neglected and hard-to-treat cancers with precision oral small molecules that target cancers in novel ways. The bold new treatments extend lives and improve healthspans, changing the outlook for patients and their families. Two therapeutic candidates have progressed into mid-stage clinical development: roginolisib is the first allosteric modulator of PI3Kδ and cambritaxestat is the only autotaxin inhibitor in clinical development to treat cancer. iOnctura BV is headquartered in Amsterdam, The Netherlands with its wholly owned Swiss subsidiary, iOnctura SA, located in Geneva, Switzerland. iOnctura is backed by specialist institutional investors including Syncona, EIC Fund, M Ventures, Inkef Capital, VI Partners and Schroders Capital.

About roginolisib

Roginolisib is the first allosteric modulator of PI3Kδ with a unique chemical structure and binding mode. The PI3K signalling pathway is one of the most commonly dysregulated pathways in cancer and the precise targeting of the PI3Kδ isoform delivers substantial anti-tumor effects with a low-toxicity profile. Clinical data have demonstrated roginolisib's excellent safety profile and sustained clinical activity in uveal melanoma (UM), a rare eye cancer with few available treatments. Randomized Phase II trials are planned to start in late 2024 in UM and other cancers, including non-small cell lung cancer and primary myelofibrosis.

About cambritaxestat

Cambritaxestat is a first-in-class autotaxin inhibitor that has shown preclinically to inhibit the growth and proliferation of cancer cells, stimulate immune cell infiltration and inhibit the development of fibrosis. It offers a new therapeutic approach for treating highly fibrotic hard-to-treat tumors such as pancreatic cancer. A Phase Ib study of cambritaxestat in combination with chemotherapy in metastatic pancreatic cancer is ongoing.

[1] Emergen Research, Jan 2024