Norwegian company Cytovation has secured Nkr62m ($6m) to progress CY-101 into a multi-national Phase II trial, targeting individuals with adrenocortical carcinoma (ACC).
The funding was raised by current investors and spearheaded by Sandwater.
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The trial is set to commence in late 2025, with initial clinical readouts anticipated in 2026. It will be a collaborative effort between the company, the Norwegian Cancer Society, and Cancer Research UK, as per an agreement established in January.
CY-101 is a membranolytic inhibitor of the wingless-related integration site (Wnt)/β-catenin pathway.
According to the company, in the Phase I CICILIA trial, this therapy showed preliminary signs of antitumor activity, especially in tumours with dysregulated signalling of Wnt/β-catenin.
Further insights into CY-101’s mechanism of action have been unveiled through new preclinical data presented by the company and its partners.
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By GlobalDataThe trials, utilising in vivo immune-refractory models of ACC, melanoma, and colorectal carcinoma (CRC), revealed that CY-101 not only eradicates ACC and CRC tumours but also amplifies the effects of anti-programmed cell death protein 1 (PD-1), thereby initiating an antitumor immune response.
These findings show that the therapy could serve as a treatment for challenging cancers, including ACC and potentially for other tumours characterised by Wnt/β-catenin signalling dysregulations such as hepatocellular carcinoma (HCC) and CRC.
The therapy’s dual-action approach involves targeting cancer cells by attacking the cell membrane and releasing neo-antigens, alongside blocking the Wnt/β-catenin oncogenic pathway.
This not only hampers the growth of the tumour, but also reverses immune exclusion linked to β-catenin expression.
The disruption of this pathway has been implicated in a spectrum of cancers, including those of the ovary, liver, uterus, colon and lung.
Cytovation CEO Lars Prestegarden said: “As we continue to explore the novel mechanism of action of CY-101 and its translation into meaningful clinical activity, our conviction in its potential to address tumours driven by the Wnt/β-catenin pathway only grows stronger.
“We are grateful for the continued support of our investors, whose confidence – alongside the strength of our outstanding partners – positions us well to advance CY-101 into Phase II trials and generate impactful clinical data.”
