Cytovation Secures $6M for Phase 2 CY-101 Trials in Adrenocortical Carcinoma

Cytovation ASA, a clinical-stage oncology enterprise headquartered in Bergen, Norway, has secured NOK62 million (equivalent to US$6 million) in funding from existing investors, with Sandwater taking the lead. This financial boost will facilitate the progression of their pioneering peptide, CY-101, into an international Phase 2 clinical trial. The trial focuses on patients with adrenocortical carcinoma (ACC) and is slated to commence towards the end of 2025. Early clinical outcomes are anticipated in 2026. This initiative stems from a collaboration with Cancer Research UK and the Norwegian Cancer Society, following an agreement formalized in January 2025.

CY-101, a unique membranolytic inhibitor targeting the Wnt/β-catenin pathway, showed promising anti-cancer properties during the Phase 1 CICILIA trial, particularly in tumors characterized by dysregulated Wnt/β-catenin signaling. New preclinical findings, which will be unveiled at the forthcoming American Association of Cancer Research (AACR) annual meeting in Chicago, provide additional understanding of CY-101’s mode of action. Conducted alongside the Luxembourg Institute of Health, these studies involved in vivo models that are typically resistant to immune responses, such as those for ACC, colorectal carcinoma (CRC), and melanoma. The results revealed that CY-101 effectively eradicates ACC and CRC tumors, boosts the performance of anti-PD-1 therapies, and incites a systemic antitumor immune reaction.

The compelling evidence supports CY-101's potential as a groundbreaking treatment option for challenging cancers like ACC, as well as tumors driven by the aberrant Wnt/β-catenin pathway, such as CRC and hepatocellular carcinoma (HCC). Lars Prestegarden, CEO of Cytovation, emphasized the growing confidence in CY-101's capabilities to tackle tumors influenced by this pathway. He acknowledged the unwavering support from investors and the solid collaboration with partners, which collectively strengthen CY-101’s journey into Phase 2 trials aimed at generating significant clinical data.

At the AACR event, a poster presentation titled "CY-101 Inhibits Tumor Growth and Improves Anti-PD-1 Immunotherapy in Beta-Catenin-Driven Tumors" will delve into the efficacy of CY-101. The session, scheduled for April 28, will be presented by Margaux Poussard and colleagues, highlighting how CY-101 enhances tumor microenvironment modulation, immunogenicity, and counteracts suppression.

Cytovation ASA is at the forefront of immune-oncology, dedicated to advancing CY-101, a first-in-class bifunctional immunotherapy. CY-101 exhibits a dual mechanism of action: targeting cancer cells by disrupting the cell membrane and releasing neo-antigens, and inhibiting the oncogenic Wnt/β-catenin pathway to curtail tumor growth and reverse immune exclusion linked to β-catenin expression. This pathway’s dysregulation is associated with various cancers, including those of the colon, liver, uterus, lungs, and ovaries. The dual functional approach of CY-101 triggers a systemic, tumor-specific immune response, offering a novel therapeutic approach for cancer treatment.