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pp-144

Suspension for infusion

Dossier type
CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
EU GMP
Comments
Indication: 2L+ advanced/metastatic cutaneous melanoma (PRAME HLA-A*02:01-positive) Clinical stage: Phase 3 Modality: Cell therapy (autologous TCR-engineered T cells) Mechanism / Target: TCR targeting PRAME cancer-testis antigen restricted to HLA-A*02:01; engineered T cells infiltrate and kill PRAME+ tumour cells; high specificity via physiological TCR-pMHC interaction Route / form: Intravenous infusion (single infusion following lymphodepletion) Differentiation: First TCR-T cell therapy in Phase 3 for solid tumour; PRAME highly expressed in melanoma; XPRESIDENT platform ensures tumour specificity and safety; gen 2 improved persistence
Manufacturer #39175

Clinical-stage cell therapy company specialising in TCR-based T-cell therapies for solid tumours. Proprietary XPRESIDENT target identification and ACTengine platforms enable cancer-specific TCR selection. Wholly owned Phase 3 pipeline targeting high-unmet-need solid tumours.
 

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