ARC01 is an mRNA therapeutic tumor vaccine that uses liposome nanoparticle (LNP) delivery technology and TriMix® immune-adjuvant technology, both of which are patented technologies that significantly enhance the body’s immune response, thereby improving the immunotherapeutic efficacy of the vaccine;
The accepted clinical study of ARC01 is an open-label, dose-escalation Phase I clinical study with a proposed enrollment of no more than 42 subjects, which is aimed at evaluating the safety, tolerability, immunogenicity, pharmacokinetic profile and efficacy of ARC01 in the treatment of HPV-16-positive advanced unresectable or recurrent/metastatic solid tumors in Chinese subjects;
Grand Pharma’s tumor immunotherapy direction has now completed the platform construction of mRNA production technology and LNP delivery technology, and has also established scientific research cooperation with a number of renowned universities and research institutes.
Recently,Nanjing Aoluo Biotechnology Co., Ltd., a subsidiary of Grand Pharmaceutical Group Limited (0512.HK), has received formal acceptance from the State Drug Administration of China (SDA) for its new drug clinical trial application (IND) for ARC01 (A002), a therapeutic oncology vaccine targeting advanced unresectable or recurrent/metastatic solid tumors that are positive for human papillomavirus type 16 (HPV-16).
Relying on exclusive patented technology, ARC01 is expected to provide a new approach to tumor treatment.
About ARC01 and its clinical trials
ARC01 is an mRNA therapeutic tumor vaccine with a drug registration classification of therapeutic biological product class 1. Through liposome nanoparticle (LNP) delivery technology, mRNA encoding the E6 and E7 antigens of HPV-16 is transfected into autologous cells and translated into the corresponding antigens, and then stimulates the body to produce specific humoral immunity and cellular immunity under the action of TriMix® immune adjuvant to ultimately achieve anti-tumor effects. The LNP delivery technology and TriMix® adjuvant technology are exclusive patented technologies that can significantly enhance the body’s immune response, thus improving the immunotherapeutic effect of the vaccine.
The accepted clinical study of ARC01 is an open-label, dose-escalation Phase I clinical study with a proposed enrollment of no more than 42 subjects, which aims to evaluate the safety, tolerability, immunogenicity, pharmacokinetic profile and efficacy of ARC01 in the treatment of HPV-16-positive advanced unresectable or recurrent/metastatic solid tumors in Chinese subjects.
About HPV
HPV is an epithelial tissue-loving, non-enveloped, double-stranded, circular DNA virus that causes proliferative lesions in human skin and mucous membranes. Among them, persistent high-risk HPV infection can cause precancerous lesions in the cervix, vagina, vulva, anus, penis, head and neck, etc., and the lesions can eventually develop into invasive carcinoma.
According to statistics, 5% of all cancers in the world are directly or indirectly related to HPV infection, of which almost 100% of cervical cancers, 88% of anal cancers, 78% of vaginal cancers, 50% of penile cancers and other tumors are related to high-risk HPV infection. And among all HPV-caused cancers, HPV-16 infection dominates, with a global HPV infection rate of about 11.7% in healthy populations, with HPV-16 infection ranking first.
In recent years, despite the fact that preventive HPV vaccines have brought a lot of help in the fight against HPV-related diseases, they still cannot cure established infections. For cancerous lesions caused by HPV infection, the current clinical treatments are mainly based on surgery, radiotherapy and chemotherapy. However, traditional treatments have the disadvantages of causing great harm to patients and being prone to recurrence. mRNA therapeutic tumor vaccines are expected to provide doctors and patients with a new and better treatment.
About Nanjing Aoluo Biotechnology
Nanjing Aoluo Biotechnology is Grand Pharma’s global innovative mRNA technology platform. Relying on its mature mRNA production process, stable and efficient LNP delivery technology and safe TriMix® adjuvant technology, Nanjing Aoluo Biotechnology has built up a research and development platform with broad applicability and scalability for the development of products related to oncology immunotherapy and vaccines for infectious diseases. The acceptance of ARC01’s IND application by the FDA is a significant progress for Grand Pharma in the field of mRNA tumor therapy.
The Board of Directors of Grand Pharma said, “Our Group focuses on the development of anti-tumor and anti-infectious mRNA drugs in the direction of tumor immunotherapy with mRNA technology as the core, and has completed the platform construction of mRNA production technology and LNP delivery technology, and has also established scientific research cooperation with a number of renowned universities and research institutes.
Grand Pharma has always attached great importance to the research and development of innovative products and advanced technologies. In the future, our Group will continue to increase its investment in innovative products and advanced technologies around the world, enrich and improve its product pipeline and industrial layout, adhere to the strategy of ”globalized operation layout, double-cycle operation and development”, and give full play to the Group’s industrial advantages and research and development strengths to fast-track its technological and innovative products to market, and provide the best service to patients around the world. Innovative products will be launched on the market to provide more advanced and diverse treatment solutions for patients around the world.”
