China Grand Pharmaceutical and Healthcare Holdings Ltd (HKG: 0512; CGP) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct an open-label, dosage escalation Phase I study for its therapeutic cancer vaccine ARC01 (A002). The study will assess the safety, tolerability, immunogenicity, pharmacokinetics, and efficacy of the vaccine in treating human papillomavirus type 16 (HPV-16)-positive advanced unresectable or recurrent/metastatic solid tumors.
The Category 1 biologic is noted as the first mRNA therapeutic cancer vaccine to be approved for clinical trials in China. ARC01 utilizes liposome nanoparticles (LNP) delivery technology to transfect mRNA encoding E6 and E7 antigens of HPV-16 into autologous cells, where they are translated into corresponding antigens. With the combined effect of the TriMix immune adjuvant, the vaccine stimulates the body to produce specific humoral and cellular immunity, ultimately achieving anti-tumor effects. The LNP delivery technology and TriMix adjuvant technology are exclusive patented technologies that significantly enhance the body’s immune response, thereby improving the immunotherapeutic effect of the vaccine.- Flcube.com
