On April 23, 2025 Cytovation ASA, a clinical stage oncology company focused on the development of its first-in-class bifunctional peptide CY-101, reported that it has raised NOK62 million (US$6m) largely from existing investors, led by Sandwater (Press release, Cytovation, APR 23, 2025, View Source;utm_medium=rss&utm_campaign=cytovation-raises-us6m-to-advance-phase-2-development-of-cy-101-in-adrenocortical-carcinoma-to-first-clinical-readouts [SID1234652053]).
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These funds will be used to advance CY-101 into a multi-national Phase 2 clinical trial in patients with adrenocortical carcinoma due to start in late 2025 and with first clinical readouts expected in 2026. The trial will be conducted through a partnership between Cytovation, Cancer Research UK and the Norwegian Cancer Society under an agreement announced in January 2025 (click here for press release).
CY-101, a membranolytic inhibitor of the Wnt/β-catenin pathway, has demonstrated early signs of antitumor activity in the Phase 1 CICILIA trial – particularly in tumors with dysregulated Wnt/β-catenin signaling.
New preclinical data being presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting (Chicago, IL; April 25-30, 2025) by Cytovation and its collaborators at the Luxembourg Institute of Health, provide further insights into the mechanistic basis of CY-101’s activity.
The studies, conducted in in vivo immune-refractory models of ACC, colorectal carcinoma (CRC) and melanoma, demonstrated that CY-101 eliminates ACC and CRC tumors, enhances the efficacy of anti-PD-1 activity and triggers a systemic antitumor immune response.
These findings support the potential of CY-101 as a novel therapeutic for difficult-to-treat cancers such as ACC, and more broadly for tumors with dysregulated Wnt/β-catenin signaling, like CRC and hepatocellular carcinoma (HCC), among others.
"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 tumors driven by the Wnt/β-catenin pathway only grows stronger," said Lars Prestegarden, CEO of Cytovation. "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 2 trials and generate impactful clinical data."
Poster Presentation at AACR (Free AACR Whitepaper)
Title CY-101 Inhibits Tumor Growth and Improves Anti-PD-1 Immunotherapy in Beta-Catenin-Driven Tumors
Poster Number 2231
Session Title PO.IM01.02 – Modulation of Tumor Microenvironment: Enhancing Immunogenicity and Counteracting Suppression
Date / Time April 28, 9:00am-12:00pm Central Time
Authors Margaux Poussard et al.
Link to abstract Abstract 2231 Cytovation-AACR
Link to ePoster Poster 2231 Cytovation-AACR (available from 12pm CT on April 28)