ARC01

ARC01 is an investigational **mRNA-based therapeutic tumor vaccine** being developed by Grand Pharma for **HPV-16-positive advanced unresectable or recurrent/metastatic solid tumors**. The product is described as a class 1 therapeutic biologic and uses **lipid nanoparticle delivery technology** to deliver mRNA encoding the **HPV-16 E6 and E7 antigens**. After cellular uptake and antigen expression, the vaccine is intended to stimulate **antigen-specific humoral and cellular immune responses** against HPV-16-driven tumors, with immune enhancement supported by the **TriMix immune adjuvant** platform. Publicly described clinical development includes an **open-label, dose-escalation Phase 1 study in China** evaluating safety, tolerability, immunogenicity, pharmacokinetics, and preliminary efficacy in patients with HPV-16-positive advanced solid tumors.