pp-146 Concentrate for solution for infusion
Dossier type
CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
EU GMP
Comments
Indication: 1L advanced cutaneous melanoma (PRAME+/HLA-A*02:01+)
Clinical stage: Phase 3
Modality: Biologic (ImmTAC bispecific: soluble TCR against PRAME peptide/HLA-A*02:01 fused to anti-CD3 scFv)
Mechanism / Target: Redirects polyclonal T cells to kill PRAME-presenting tumour cells; targets intracellular antigen presented on MHC-I — inaccessible to conventional mAbs
Route / form: Intravenous infusion (weekly)
Differentiation: Access to intracellular proteome (99%+ of tumour antigens); allele-specific targeting; ImmTAC proven class (tebentafusp approved for uveal melanoma 2022); 1L setting
Manufacturer #39177
Commercial-stage biopharmaceutical with approved ImmTAC bispecific for uveal melanoma. Pioneers TCR-based bispecific T-cell engagers targeting intracellular tumour antigens. Wholly owned Phase 3 cutaneous melanoma programme expanding the ImmTAC platform.
None