XP-004 / Shanghai Xinpu BioTech - LARVOL DELTA

An investigator-initiated phase I study evaluating the safety, tolerability, and preliminary efficacy of a personalized neoantigen mRNA vaccine (XP-004) combined with PD-1 inhibitor as adjuvant therapy in resected pancreatic cancer patients intolerant to chemotherapy. (ASCO 2026) - P1 | "Patients received XP-004 intramuscularly (1.0 mg Q3W for 13 cycles), including a KRAS-targeted single-neoantigen vaccine for 4 cycles followed by a personalized multi-neoantigen vaccine for 9 cycles, combined with toripalimab (PD-1 inhibitor). XP-004 combined with PD-1 inhibitor demonstrated favorable safety and tolerability and induced robust neoantigen-specific T-cell responses in resected pancreatic cancer patients intolerant to chemotherapy. Early follow-up suggests potential RFS benefit, supporting further investigation of this adjuvant immunotherapy strategy."

Clinical • IO biomarker • New P1 trial • P1 data • Tumor-specific neoantigens • Oncology • Pancreatic Cancer • Pruritus • Solid Tumor • CD4 • CD8 • CXCL8 • IFNG • IL10 • IL5 • IL6 • KRAS