GSK Re-Entering HPV Vaccine Market With Help

The China-based company Xiamen Innovax Biotech and GSK Biologicals (GSK) announced they have entered a partnership for the development and commercialization of a next-generation adjuvanted Human Papillomavirus (HPV) vaccine.

To date, this is the first time that a Chinese vaccine company has entered into a partnership with the largest vaccine company in the world to co-develop and ultimately commercialize an HPV vaccine, said Xiamen on September 6, 2019, in a press release.

There are more than 100 types of HPV, of which at least 14 are high-risk and cancer-causing.

GSK’s existing HPV vaccine, Cervarix, was removed from the US market after finding it was not competitive against the Gardasil vaccine from Merck.

Roger Connor, President of GSK Global Vaccines, said: “HPV-related cancers are still, unfortunately, a major cause of death for women worldwide. This partnership aims to deliver a vaccine for HPV that leverages GSK’s proprietary adjuvant system, AS04 with antigen technology developed by Innovax.”

In collaboration with the National Institute of Diagnostics and Vaccine Development in Infectious Diseases (NIDVD), Innovax has established a core-platform using DNA recombinant technology to express protein in E. coli for vaccine production. 

Based on this platform, a cervical cancer vaccine named Cecolin (HPV 16&18 bivalent, BLA submitted in 2017) have been developed. Furthermore, a 9-valent HPV vaccine is now in phase II clinical trial, says Innovax.

Cervarix, Gardasil, and Gardasil 9 are the 3 non-infectious prophylactic Food and Drug Administration (FDA)-approved HPV licensed subunit vaccines in active usage. These vaccines were developed from the major capsid L1 virus-like particles (VLPs) using recombinant DNA technology. 

Cervarix is a bivalent vaccine based on Baculovirus fermentation and it provides ~70 percent protection against HPV (16 and 18)-mediated cervical cancer, but not against genital warts.

The main limitations of currently available prophylactic vaccines are as follows: they are strain-specific, not therapeutic for patients already infected with HPV, they require multiple dosages, and are expensive.

In addition, the effective straightforward delivery of HPV vaccines can enhance the immunogenic potential against HPVs, reported a January 2019 study.   

With this alliance, both GSK and Innovax will continuously support the work of the World Health Organization (WHO), which aims to eliminate cervical cancer worldwide.

Each year 800,000 women die of cervical and breast cancer, mostly in low and middle-income countries (LMICs), said the WHO in 2018.

But, several proven, cost-effective interventions exist to tackle these common cancers.

For example, estimates suggest that universal HPV vaccination of all girls aged 12 years of age could prevent 690,000 cases and 420,000 deaths worldwide, most of which would be in LMICs.

And in the USA, according to the Centers for Disease Control and Prevention (CDC) on August 23rd, 2019, there were more HPV related oropharyngeal cancer (12,600) cases than cervical cancer (9,700).

Oropharyngeal cancer was the most common cancer attributable to HPV in all states, except in Texas, where cervical cancer was most common.

HPV related oropharyngeal cancers are found in both men and women in the back of the throat, including the base of the tongue and tonsils.

GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit GSK.

Innovax Biotech Co., Ltd. is a leading company in the field of developing, manufacturing and marketing innovative vaccines with its headquarters and manufacture based in Xiamen, China.

Published by Vax Before Cancer