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Research Report
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.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
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2022/05/20 | Phase 1 | Active, not recruiting | |||
2020/02/07 | Phase 1 | Completed | |||
2019/02/19 | Phase 1 | Completed | Centre for Human Drug Research, Netherlands |
FDA Drug Approvals
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No FDA approvals found for this drug. |
EMA Drug Approvals
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No EMA approvals found for this drug. |
HSA Drug Approvals
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No HSA approvals found for this drug. |
NMPA Drug Approvals
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No NMPA approvals found for this drug. |
PPB Drug Approvals
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No PPB approvals found for this drug. |
TGA Drug Approvals
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No TGA approvals found for this drug. |
Health Canada Drug Approvals
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No Health Canada approvals found for this drug. |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
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No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
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No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
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No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
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No UK EMC drug information found for this drug. |
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