CyPep-1 / CY-101: A Novel Dual-Mechanism Oncolytic Peptide in Clinical Development

I. Executive Summary

The investigational agent CyPep-1, now predominantly referred to as CY-101 in its oncological development by Cytovation AS, represents a novel, first-in-class therapeutic candidate. It is a synthetic, 27 D-amino acid cationic lytic peptide engineered for the treatment of various cancers.[1] A significant attribute of CY-101 is its innovative dual mechanism of action. The peptide directly targets and disrupts cancer cell membranes, leading to rapid cell lysis and the release of tumor antigens, a process designed to induce immunogenic cell death and an in situ vaccination effect.[3] Concurrently, CY-101 has been shown to inhibit the Wnt/β-catenin signaling pathway, a critical oncogenic driver in many malignancies.[2] This dual approach distinguishes CY-101 from many other oncolytic agents. The evolution in nomenclature from the general research term "CyPep-1" to the oncology-specific "CY-101" signifies a deliberate strategic focusing of its development program, reflecting an increasing understanding of its specific mechanisms in cancer and a commitment to this therapeutic area. This is further differentiated from an earlier formulation, CyPep-H1, which was explored for dermatological conditions.[7] Such shifts in designation often occur as a product matures and its lead indication becomes more clearly defined, underscoring Cytovation's strategic direction for CY-101 in oncology.