bifikafusp alfa   Click here for help

GtoPdb Ligand ID: 9756

Synonyms: Daramun (bifikafusp alfa and onfekafusp alfa) | Darleukin | L19-IL2 | L19IL2 | Nidlegy (bifikafusp alfa and onfekafusp alfa)
Immunopharmacology Ligand
Compound class: Antibody
Comment: Bifikafusp alfa (Darleukin) is a fusion protein of pro-inflammatory IL-2 and an L19 human mAb fragment (scFv domain) that binds the tumour microenvironment expressed fibronectin extradomain B (EDB) [1]. Structurally it is a diabody with two IL-2 units per molecule. Incorporation of the L19 binding fragment targets the drug to the tumour, improving selective site accumulation and tumour killing and at the same time reducing the effective dose required to achieve a meaningful response, and reducing the otherwise dose-limiting toxicities associated with high-dose IL-2 administration that would be required to produce the same killing effect. Darleukin is one of a growing number of so-called 'immunocytokines' entering clinical development.
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Summary of Clinical Use Click here for help
Darleukin (L19-IL2) has reached Phase 1 and 2 clinical trials in a number of types of advanced solid tumours. A combination with a similarly designed L19-TNF trivalent antibody fusion called onfekafusp alfa is in Phase 3 clinical trial NCT02938299 for malignamt melanoma (Phase 2 results published in [2]).
Clinical Trials
Clinical Trial ID Title Type Source Comment References
NCT02938299 Neoadjuvant L19IL2/L19TNF- Pivotal Study Phase 3 Interventional Philogen S.p.A.