naptumomab estafenatox   Click here for help

GtoPdb Ligand ID: 9948

Synonyms: ABR-217620 | ABR217620 | Anyara (proposed trade name) | TTS CD3 | TTS-CD3
Immunopharmacology Ligand
Compound class: Antibody
Comment: Naptumomab estafenatox (ABR-217620) is an immuno-oncology clinical candidate biologic drug that is being developed by Active Biotech and NeoTX Therapeutics. It is a fusion protein containing a 5T4 (tumor-associated oncofetal trophoblast glycoprotein antigen) Fab moiety fused via the C terminus of the heavy chain to an engineered hybrid of Staphylococcus entertoxins A and E (SEA/E-120) superantigens [1]. Staphylococcal superantigens are secreted by the pathogen and stimulate a massive MHC class II-T cell receptor-mediated polyclonal T cell activation, which results in the release of large amounts of cytotoxic and proinflammatory cytokines and potent T-cell-mediated killing of tumour cells. Naptumomab estafenatox targets the destructive power of SEA/E-120 to 5T4-expressing tumour cells. The SEA/E-120 moiety is engineered to reduce MHC class II binding affinity so as to reduce killing of bystander MHC class II positive cells.
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Summary of Clinical Use Click here for help
Naptumomab estafenatox (ABR-217620) has completed Phase 2/3 clinical trial in patients with advanced renal cell carcinoma (see NCT00420888 which assessed ABR-217620 + plus IFN-α vs. IFN-α monotherapy) [1-2,4]. However, the primary endpoint of showing a prolonged overall survival was not met in this trial. According to the Active Biotech webpage for Anyara, they are planning a trial of Anyara in PD-1 inhibitor-refractory solid cancers.
Clinical Trials
Clinical Trial ID Title Type Source Comment References
NCT00420888 ABR-217620/Naptumomab Estafenatox With Interferon-alpha (IFN-alpha) Compared to IFN-alpha Alone in Patients With Advanced Renal Cell Carcinoma Phase 2/Phase 3 Interventional Active Biotech AB