Beijing Health Guard Biotechnology Inc. (thereafter, the Company) is developing a peptide vaccine against COVID-19. The vaccine is made by inserting genes of the effective antigen epitopes of SARS-CoV-2 into the gene encoding the structural protein of another virus, which is then recombinantly expressed as a fusion protein in vitro. The target peptide epitopes of SARS-COV-2 will be presented on the surface of the virus like particle assembled from such fusion protein. Administration of the peptide vaccine formulated with the fusion protein will induce antibodies against SARS-CoV-2, which will neutralize the virus and therefore protect the cells against viral infection.
The epitope delivery technology based on HPV VLP can overcome bottlenecks of developing recombinant SARS-CoV-2 VLP-based vaccine, particularly difficulty in expressing and purifying SARS-CoV-2 VLP that indicates a challenging and lengthy development cycle. Moreover, the epitope delivery technology avoids low immunogenicity problem plaguing peptide vaccines. Recombinant protein-based vaccines are safe and require no special development and manufacturing facilities. That is in sharp contrast with inactivated vaccines which must be produced at a high-level biosafety facility. It is also worth noting that peptide vaccines have minimum risks of antibody-dependent enhancement (ADE), a phenomenon observed in animal studies of SARS-CoV inactivated vaccines which showed the antibodies generated by the vaccine actually help the virus infect greater numbers of cells than it would have on its own.
The Company launched the COVID-19 vaccine project immediately after the Spring Festival holiday. Drawing upon its years of experience in developing recombinant vaccines and established R&D platform, the Company came to choose to develop a chimeric HPV VLP-based peptide vaccine. So far, this COVID-19 vaccine project goes well as the Company has intensified its development efforts since the Company came back to office on February 10. Over the past decade, the Company has accumulated a lot of experience and knowhow in developing VLP-based vaccines against HPV, Norovirus, and EV71, with two vaccines in clinical trials. After the outbreak of the COVID-19 pandemic, the Company moved fast to design and validate its peptide COVID-19 vaccine by the use of existing R&D platform and technical capability, and has identified a vaccine candidate. The Company is now conducting animal studies to evaluate immunogenicity of the candidate peptide vaccine, and will further evaluate the candidate’s safety once its immunogencity is determined to be favorable. Meanwhile, the Company is developing and optimizing manufacturing process of the candidate peptide vaccine.
There is no COVID-19 vaccine licensed worldwide so far, which suggests the global community is inexperienced in COVID-19 vaccine development, especially assessment of vaccine efficacy and safety. Therefore, COVID-19 vaccine development will be challenging for the vaccine industry in terms of sufficiently justifying risks and benefits. Moreover, vaccines are indicated for use in healthy people and thus safety will always be put first for vaccine development. The Company hopes to bring a safe and effective COVID-19 vaccine to the market soon with support from all parties.
Beijing Health Guard, founded and registered in Beijing Economic-Technological Development Area (BDA) in 2008, is dedicated to developing innovative biologics and becoming a leading biopharmaceutical company in China and across the world. The Company was restructured as a share holding enterprise in May 2013, and was listed on the NEEQ (National Equities Exchange and Quotations) in September 2015. Shares of the Company are trading under the ticker Health Guard and stock code 833575. The Company is certified as a High and New Technology Enterprise (HNTE), and the Health Guard team includes more than 80 industry professionals with deep experience in research and development activities. Our chief scientific officer (CSO), USC professor Xiaojiang Chen, is a fellow of the AAAS and a serial entrepreneur who also cofounded Taligen Therapeutics which was acquired by Alexion Pharmaceuticals in 2011.
Since its inception, the Company has accumulated a multitude of strengths in protein-based biopharmaceutical R&D, including among others Structure-guided antigen design, Protein engineering and expression, Biopharmaceutical process development, Recombinant protein vaccines potency evaluation. The Company owns a pilot plant with an area of 1500+ square meters, which complies with cGMP standards and meets the requirements for process scale-up as well as clinical manufacturing.
The Company has developed a recombinant trivalent HPV vaccine (targeting HPV16/18/58) that has completed phase II study, a recombinant nonavalent HPV vaccine (targeting 6/11/16/18/31/33/45/52/58) that is in phase II study, and is developing a recombinant 15-valent HPV vaccine that is in pre-clinical development. All the three HPV vaccines are indicated for the prevention of cervical cancer.
While beefing up R&D efforts in the race against SARS-COV-2, the Company is also actively looking for industry partners and investors for funding support, to help move the COVID-19 vaccine project into clinical trial as soon as possible. We are grateful to Beijing Jingkai Investment Development Company Limited and Beijing E-town International Financing and Leasing Co., Ltd. for reducing the rent on our R&D facility and offering us favorable equipment financing and leasing rates during the pandemic. We firmly believe that, with hard work and perseverance, the Company will achieve its goal of developing and supplying advanced and effective vaccines as soon as possible under the support of governments and relevant parties.