Cytovation to Advance Development of CY-101 for Cancers Driven by Dysfunction of Wnt/β-catenin Signalling Under International Nonproprietary Name of Getacatetide
- Plans to initiate Phase 2 clinical trial in Adrenocortical Carcinoma in early 2026 through unique partnership between Cytovation, Cancer Research UK and the Norwegian Cancer Society
Bergen, Norway, July 23, 2025 – Cytovation ASA, a clinical stage oncology company focused on the development of its first-in-class bifunctional peptide CY-101, announces that the International Nonproprietary Names (INN) Expert Committee of the World Health Organization (WHO-INN) has approved "getacatetide" as the International Nonproprietary Name (INN) of CY-101.
The INN reflects the nature of getacatetide as an engineered, highly stable synthetic peptide with unique, antitumoral properties. Getacatetide is a membranolytic inhibitor of the Wnt/β-catenin pathway and helps the immune system to fight cancer by exposing tumor neoantigens and inhibiting mechanisms that drive tumor growth and immune evasion. Getacatetide has demonstrated early signs of antitumor activity in the Phase 1 CICILIA trial – particularly in tumors with dysregulated Wnt/β-catenin signaling.
These findings, supported by new preclinical data presented at the American Association of Cancer Research (AACR) annual meeting in April 2025, highlight the potential of getacatetide as a novel therapeutic for difficult-to-treat cancers including adrenocortical carcinoma (ACC), and more broadly for tumors with dysregulated Wnt/β-catenin signaling, including colorectal cancer (CRC) and hepatocellular carcinoma (HCC), among others.
A multi-national Phase 2 trial to investigate the safety and efficacy of getacatetide in patients with ACC is on track to start in early 2026 with first clinical readouts expected before the end of 2026. The trial will be conducted through a unique partnership between Cytovation, Cancer Research UK and the Norwegian Cancer Society under an agreement announced in January 2025 (click here for press release).
Lars Prestegarden, CEO of Cytovation, said: “As we continue with the preparations for our Phase 2 clinical trial in ACC together with our partners, receiving approval for the INN for getacatetide marks another step in advancing our mission to make immunotherapy effective across a wider range of patients and cancer types. We look forward to communicating on further progress over the next 12-24 months.”
####
About Cytovation
Cytovation ASA is a clinical stage immune-oncology company focused on the development of getacatetide (formerly known as CY-101), a first-in-class bifunctional immunotherapy.
Getacatetide has a unique dual mechanism of action, specifically eliminating cancer cells by targeting the cell membrane and releasing neo-antigens, and by inhibiting the Wnt/β-catenin oncogenic pathway to restrict tumor growth and reverse immune exclusion associated with β-catenin expression. Dysregulation of this pathway has been associated with several different cancer types including colon, liver, uterine, lung and ovarian cancer, among others. This dual mode of action induces a systemic, tumor-specific immune response.
For more information, please visit www.cytovation.com.
Contact Information
Cytovation
Federico Grego, Chief Operating Officer/Chief Financial Officer: contact@cytovation.com
MEDiSTRAVA
Frazer Hall / Mark Swallow: cytovation@medistrava.com
Legal Disclaimer:
EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.
