Norwegian cancer specialist Cytovation ASA has secured an additional $6 million (NOK62 million) in funding to advance its innovative cancer therapy CY-101 into Phase II clinical trials. The financing was primarily provided by Series A lead investor Sandwater and other existing backers, including the Norwegian Cancer Society, bringing the company's total capital to $34 million.
The new funding will support a multi-center Phase II trial conducted in collaboration with Cancer Research UK, focusing on patients with adrenocortical carcinoma (ACC). The study is scheduled to begin in late 2025, with initial clinical readouts anticipated next year.
Novel Mechanism Targeting Beta-Catenin Driven Cancers
CY-101 represents a novel approach to cancer treatment with its dual mechanism of action. As a membranolytic inhibitor, it forms pores in cancer cell membranes, triggering the release of neoantigens into the tumor microenvironment and stimulating an immune response. Additionally, CY-101 inhibits the oncogenic Wnt/beta-catenin signaling pathway, which is frequently dysregulated in several cancer types.
Lars Prestegarden, CEO of Cytovation, highlighted the therapeutic potential of targeting this pathway: "Given the high prevalence of beta-catenin mutations in tumors such as colorectal carcinoma, adrenocortical carcinoma, and melanoma, targeting this pathway offers significant therapeutic potential."
Promising Preclinical Results
Cytovation will present new preclinical data on CY-101 at the upcoming American Association for Cancer Research (AACR) annual meeting in Chicago. The data demonstrate that CY-101 induces dose-dependent cell death across mouse and human beta-catenin-driven cancer cell lines following suppression of the Wnt/beta-catenin pathway.
In animal models, CY-101 showed remarkable efficacy, completely eradicating ACC tumors and significantly enhancing the effectiveness of anti-PD-1 therapy in colorectal cancer and melanoma models. The treatment also reshaped the tumor immune landscape by modulating cytokine expression and increasing infiltration of cytotoxic CD8-expressing T cells.
Mechanistically, tumors treated with CY-101 exhibited downregulation of Wnt/beta-catenin downstream target genes. These preclinical findings align with observations from the first-in-human CICILIA Phase I/IIa trial, which reported clinical activity in ACC and melanoma patients.
Expanding Therapeutic Applications
The new preclinical results support CY-101's potential as a novel therapeutic not only for difficult-to-treat cancers like ACC but also more broadly for tumors with dysregulated Wnt/β-catenin signaling, including colorectal cancer and hepatocellular carcinoma.
The upcoming Phase II trial represents a significant milestone in Cytovation's clinical development program and could potentially address significant unmet needs in oncology, particularly for patients with limited treatment options.
With the additional funding secured and promising preclinical data, Cytovation is well-positioned to advance its innovative cancer therapy through clinical development, potentially offering new hope for patients with beta-catenin-driven cancers.
