2023-11-02 16:48:56
© Archyde.com. Focusing on cancer caused by HPV infection, China Grand Pharmaceutical’s (00512) mRNA therapeutic tumor vaccine ARC01 has been accepted for domestic IND
According to Zhitong Finance APP, recently, the Hong Kong-listed scientific and technological innovative pharmaceutical company Yuanda Pharmaceutical (00512) has received another positive news from the research and development of innovative products. The company announced on November 2 that its subsidiary Nanjing Oro Biotechnology Co., Ltd. (Oro Bio)’s new drug clinical trial application (IND) for the therapeutic tumor vaccine ARC01 (A002) has been officially accepted by the State Food and Drug Administration. This is a major progress for Yuanda Pharmaceutical in the field of mRNA tumor treatment. It is also the company’s sixth accepted IND this year, ranking among the top in the industry in terms of number.
It is reported that ARC01 is an mRNA therapeutic vaccine targeting human papillomavirus type 16 (HPV-16)-positive late-stage unresectable or recurrent/metastatic solid tumors. Currently, there is no corresponding drug with similar indications in the domestic market. Yuanda Pharmaceutical ARC01 In the future, it may fill the domestic market gap for malignant tumors caused by HPV-16 infection and provide new options for clinical treatment.
Supported by exclusive patented technology, ARC01 has considerable future potential
According to the announcement, ARC01 is an mRNA therapeutic tumor vaccine, and the drug registration classification is Class 1 therapeutic biological products. This product uses liposome nanoparticle (LNP) delivery technology to transfect the mRNA encoding the E6 and E7 antigens in HPV-16 into autologous cells and translate the corresponding antigens. Under the combined action of TriMix® immune adjuvant, it stimulates the body to produce specific Sexual humoral immunity and cellular immunity ultimately achieve anti-tumor effects.
LNP delivery technology and TriMix® adjuvant technology are exclusive patented technologies that can significantly enhance the body’s immune response, thereby improving the immunotherapy effect of the vaccine. Among them, LNP delivery technology has stronger tissue penetration, higher transfection efficiency and nucleic acid encapsulation rate, and lower cytotoxicity. It is recognized as one of the most advanced nucleic acid delivery carriers in the industry; TriMix® is a product of the University of Brussels A novel adjuvant strategy developed using high-dose TriMix mRNA treatment was shown to stimulate and detect high human immunodeficiency virus-specific T cell responses, while also demonstrating the high safety and tolerability of this strategy. receptive nature.
The acceptance of ARC01 this time is an open-label, dose-escalating Phase I clinical study, which is planned to enroll no more than 42 subjects. It is designed to evaluate the efficacy of ARC01 in the treatment of patients with HPV-16-positive late-stage unresectable or recurrent/ Safety, tolerability, immunogenicity, pharmacokinetic characteristics, and efficacy in Chinese subjects with metastatic solid tumors.
Focusing on the blue ocean of cancer caused by HPV infection, advantageous innovative products may provide new treatment methods
HPV is a non-enveloped double-stranded circular DNA virus that is epithelial and can cause proliferative lesions of human skin and mucous membranes. Among them, persistent infection with high-risk HPV can cause precancerous lesions in the cervix, vagina, vulva, anus, penis, head and neck and other parts of the body, and the lesions can eventually develop into invasive cancer.
As the main cause of cancers such as cervical and anogenital malignant tumors, HPV is still a “silent killer” threatening public health. According to statistics, 5% of current cancers in the world are directly or indirectly related to HPV infection. Among them, almost 100% of cervical cancer, 88% of anal cancer, 78% of vaginal cancer, 50% of penile cancer and other tumors are related to high-risk tumors. Types of HPV infection. Among all cancers caused by HPV, HPV-16 infection dominates. The global HPV infection rate among healthy people is about 11.7%, among which HPV-16 infection rate ranks first.
In recent years, although preventive HPV vaccines have brought a lot of help to the prevention and treatment of HPV-related diseases, they are still unable to cure confirmed infections. According to data from the Global Cancer Observatory (GLOBOCAN), there were 604,000 new cases of cervical cancer and 342,000 deaths worldwide in 2020. It is expected that by 2040, the number of new cases of cervical cancer will reach 798,000 and the number of deaths will reach 481,000. ; There were 110,000 new cases of cervical cancer and 59,000 deaths in China in 2020, an increase of approximately 3.5% and 23.0% respectively compared to 2018. In addition, a 2019 Chinese systematic review of 198 studies showed that among ordinary adult women aged 25-45 in China, the high-risk HPV infection rate is as high as 19.9%, which means that on average, 1 in 5 people is infected with high-risk HPV types. .
The high infection data means that most people in my country are still facing the risk of cancer caused by HPV infection, which also means that there is an urgent need for treatments for related diseases. Judging from the current clinical treatment methods in my country, traditional surgery, radiotherapy and chemotherapy are still the most important treatment methods. These treatment methods have the disadvantages of being harmful to patients and prone to recurrence. There is an urgent need for safer and more effective clinical treatment options.
A CITIC Securities research report pointed out that the global market size of mRNA vaccines (non-COVID-19) is expected to reach US$28.1 billion in 2025, of which mRNA tumor vaccines are expected to reach a penetration rate of 0.5% in 2025, corresponding to a market size of approximately US$10.5 billion.
Against this background, the forward-looking layout of Yuanda Pharmaceutical ARC01 once again highlights the company’s unique ability and vision in exploring market segments. Looking at the current drug market for HPV-positive advanced unresectable or recurrent/metastatic solid tumors, no corresponding drugs have yet been approved for marketing. Among foreign companies, although companies such as BioNTech have also discovered the business opportunities contained in this blank market, related products are still in the clinical research stage. In the blue ocean market for cancers caused by HPV infection, ARC01 is expected to provide doctors and patients with a new and better treatment method in the future.
Forward-looking layout of the mRNA track, differentiated innovation is expected to take the lead
Yuanda Pharmaceutical takes mRNA technology as its core in the direction of tumor immunotherapy and focuses on the development of anti-tumor and anti-infective mRNA drugs. It has currently completed the construction of platforms for mRNA production technology and LNP delivery technology, and has also cooperated with many well-known universities and research institutes. Established scientific research cooperation.
Oro Biotech, to which ARC01 belongs, is Grand Pharmaceutical’s global innovative mRNA technology platform. It relies on mature mRNA production technology, stable and efficient LNP delivery technology and safe TriMix® adjuvant technology to establish a R&D platform with broad applicability and scalability. , used for the research and development of related products such as tumor immunotherapy and infectious disease vaccines.
Regarding future development, Yuanda Pharmaceutical stated that the company will continue to attach importance to the research and development of innovative products and advanced technologies, continue to increase investment in global innovative products and advanced technologies, enrich and improve product pipelines and industrial layout, and adhere to the “global operation layout” , dual-cycle operation and development” strategy, giving full play to the company’s industrial advantages and R&D capabilities, quickly launching technologically innovative products onto the market, and providing more advanced and diverse treatment options to patients around the world.
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