SK bioscience announced on the 4th that the company has enrolled a Phase I/II clinical trial for its COVID-19 vaccine candidate, ‘GBP510’, being developed with support from the Bill & Melinda Gates Foundation and the Coalition for Epidemic Preparedness Innovations (CEPI) in combination with the global healthcare company GlaxoSmithKline’s (GSK) pandemic adjuvant.

The study initiation follows promising pre-clinical study results conducted by SK bioscience with GBP510, showing it induced higher titers of neutralizing antibodies as well as activation of T cell which induces humoral and cellular immune responses when combined with GSK’s pandemic adjuvant.

An adjuvant is added to some vaccine formulations to enhance the immune response to the vaccine antigen, thereby creating a stronger and longer lasting immunity against infections than the vaccine antigen alone. GSK is a leader in the development of innovative vaccines using different adjuvant systems and its pandemic adjuvant system is supported by extensive clinical and safety data.

Jaeyong Ahn, CEO of SK bioscience said, “Promising early data for our COVID-19 vaccine candidate has led to cooperation with a leading global vaccine company, GSK. SK bioscience plans to develop and supply more accessible and affordable vaccine candidates with proven safety and efficacy record”.

Thomas Breuer, CMO GSK Vaccines said, “While it is encouraging to see the initial roll out of COVID-19 vaccines in developed countries, there is still a significant need for more options to meet the world’s demand. We look forward to collaborating with SK bioscience and believe its candidate vaccine combined with our adjuvant could represent an important additional solution to the pandemic”.

In December 2020, GBP510 wased as the first ‘Wave2’ vaccine investment project jointly funded by CEPI and the Bill & Melinda Gates Foundation to develop more accessible and affordable COVID-19 vaccines that are differentiated from those already in advanced development.

As part of the ‘Wave2’ project, GBP510 will be supplied world-wide through the COVAX facility led by supranational organizations such as CEPI, Gavi, the Vaccine Alliance, and World Health Organization (WHO), provided the candidate vaccine development is completed successfully and approved for use.

SK bioscience has been developing a self-assembly nanoparticle vaccine candidate targeting the receptor binding domain (RBD) of SARS-CoV-2 Spike protein, GBP510, which has a feature maximizing the immune response, in collaboration with the Institute for Protein Design (IPD) at the University of Washington School of Medicine under the fund created by the Bill & Melinda Gates Foundation, since May 2020. Results of the Phase I/II trial are anticipated in the middle of this year.

Separately, SK bioscience is pursuing a two-track strategy to develop its own COVID-19 vaccine candidates based on platform technology, and to collaborate with global partners to provide contract manufacturing for their COVID-19 vaccine candidates simultaneously.

A Phase I clinical trial of ‘NBP2001’, another COVID-19 vaccine candidate developed by SK bioscience, has been initiated in multiple clinical sites, including Seoul National University Hospital.

Under a contract manufacturing organization (CMO) contract with AstraZeneca, SK bioscience has also been manufacturing drug substance and drug product for the COVID-19 vaccine candidate developed by Oxford University-AstraZeneca since last July.

SK bioscience entered also made an agreement with CEPI in June 2020 to reserve a manufacturing capacity of SK bioscience’s vaccine manufacturing plant, L HOUSE in Andong for the development and production of COVID-19 vaccine candidates supported by CEPI. By leveraging the capacity reservation agreement, SK bioscience is manufacturing the antigen component of the COVID-19 vaccine candidate developed by the U.S.-based biotechnology company Novavax under a contract development and manufacturing organization (CDMO) agreement.