GSK and Wantai Biological to Co-Develop Next-Generation Cervical Cancer Vaccine

Recently, a noteworthy development emerged in the vaccine industry: On September 6, at GSK Biologicals’ Wavre vaccine headquarters in Belgium, Xiamen Innovax (a subsidiary of Yangshengtang) and global vaccine giant GlaxoSmithKline (GSK) signed a global collaboration agreement, announcing that both parties would jointly develop next-generation human papillomavirus (HPV) vaccines by combining Innovax’s innovative antigen technology originating from Xiamen University with GSK’s adjuvant system.

This marks the first time that China’s vaccine industry has leveraged proprietary technology to collaborate closely with top-tier international vaccine companies in the joint development and global commercialization of blockbuster vaccine products, signifying that China’s core key technologies in vaccines have gained high recognition from international peers.

Under this agreement, INNOVAX will construct a vaccine production line in Haicang, Xiamen, compliant with the standards of China, the United States, the European Union, and the WHO. It will supply GSK with antigens for multiple HPV vaccine types, which GSK will combine with its proprietary AS04 adjuvant to develop new HPV vaccines and commercialize them globally, including in Europe and the United States.

GSK stated that this collaboration with INNOVAX will help accelerate the development of its next-generation cervical cancer vaccine.

Proprietary E. coli Expression Platform: Simple Cultivation and Rapid Reproduction

According to the World Health Organization’s 2018 statistics, cervical cancer is the third most common cancer among women. Globally, there are approximately 570,000 new cases of cervical cancer and about 311,000 deaths each year. In China, there are approximately 106,000 new cases and about 48,000 deaths annually. In 2018, the global supply capacity for HPV routine immunization was only 30 million doses, approximately one-third of the total demand.

This collaboration between the two parties holds positive significance for addressing the current imbalance between supply and demand for cervical cancer vaccines. Roger Connor, Chairman of GSK Vaccines, stated, “I am pleased to partner with INNOVAX to address this critical public health need.”

INNOVAX’s antigen technology, which attracted GSK’s interest, successfully utilizes DNA recombinant technology to express virus-like particle (VLP) antigens in Escherichia coli for vaccine production. Its unique advantages include simple cultivation, rapid proliferation, ease of mass production, and favorable druggability.

This technology originated from the Xiamen University–Yangshengtang Joint Laboratory of Biological Pharmaceuticals, led by Professor Xia Ningshao. In 2005, it was approved by the Ministry of Science and Technology as the National Engineering Research Center for Diagnostic Reagents and Vaccines for Infectious Diseases. In 2017, this breakthrough earned the Qiushi Outstanding Achievement Award in Science and Technology (Team), hailed as having pioneered a new pathway for the industrialization of genetically engineered vaccines.

Based on this platform technology, Xiamen Innovax developed Hecolin®, the world’s only commercially approved hepatitis E vaccine. This vaccine has demonstrated its safety, immunogenicity, and efficacy in clinical trials involving more than 100,000 adults. It was approved for marketing in China in 2012 and was approved by the U.S. FDA for clinical trials in April of this year.

YiKeNing® is not only the world’s first hepatitis E vaccine, but also the first viral vaccine globally developed using an Escherichia coli expression system, fundamentally overturning the international academic consensus that “prokaryotic systems cannot be used for viral vaccine development.” Meanwhile, 12 invention patents covering key technologies in this R&D platform have been filed in 14 major countries, holding profound significance for China’s development of innovative vaccines with independent intellectual property rights.

Following the establishment of a strategic partnership between GSK and INNOVAX, the two companies will leverage GSK’s proprietary AS04 adjuvant system and antigens developed by INNOVAX to develop next-generation HPV vaccines. GSK’s adjuvant systems (AS) are combinations of immunomodulators that enhance and direct the immune system to mount an optimal response against infection.

Chinese Scientists Take the Lead in Opening the Door to the Development of Third-Generation Cervical Cancer Vaccines

WanTai’s ability to achieve key breakthroughs in the research and development of hepatitis E and HPV vaccines is inseparable from its collaboration with Xiamen University and Professor Xia Ningshao’s team. Over the years, Professor Xia’s team has consistently maintained a high rate of translation for scientific achievements. Together with WanTai Bio, the team successfully developed China’s third- and fourth-generation HIV diagnostic reagents, the hepatitis E vaccine, and other products.

For many years, Professor Xia Ningshao’s team has conducted a series of studies on the application and basic research of HPV vaccines, including elucidating the assembly mechanism of HPV virus-like particles (VLPs) produced in Escherichia coli; developing China’s first domestically produced first-generation cervical cancer vaccine, which is about to be marketed in China; completing Phase II clinical trials for a condyloma acuminatum vaccine; and obtaining clinical trial approval for a second-generation cervical cancer vaccine.

Existing first- and second-generation cervical cancer vaccines both use “virus-like particles” (VLPs), which resemble the natural viral particles of HPV, as vaccine antigens. Among these, the nonavalent vaccine can prevent approximately 90% of cervical cancers; however, it does not cover the HPV types associated with the remaining nearly 10% of cases.

In December 2018, Professor Xia Ningshao’s team published their research findings on a next-generation human papillomavirus (HPV) vaccine in Nature Communications, a subsidiary journal of Nature, marking a highly significant milestone for the development of a 20-valent cervical cancer vaccine.

They leveraged emerging structural vaccinology approaches to design a sophisticated “chimeric virus-like particle.” This particle integrates the “loop” features of three HPV types, overcoming the previous limitation where one virus-like particle could mimic only one HPV type, thereby enabling a single virus-like particle to mimic the morphology of three HPV types.

This also means that they have obtained a third-generation cervical cancer vaccine that requires only seven types of virus-like particles (VLPs) to cover twenty HPV genotypes. For the first time internationally, a single HPV VLP has been engineered to simultaneously protect against three HPV genotypes, thereby increasing the number of vaccine-preventable viral genotypes while reducing the variety of VLP antigens required in the vaccine.

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