GSK Expands COVID-19 Vaccine Pipeline to Four Candidates Amid Global Race for Market Leadership

On August 31 local time, GlaxoSmithKline (hereinafter referred to as "GSK") and South Korean pharmaceutical company SK Bioscience (hereinafter referred to as "SK") jointly announced the initiation of a Phase 3 clinical trial evaluating SK bioscience's COVID-19 candidate vaccine GBP510 in combination with GSK's vaccine adjuvant. Trial data are expected to be released in the first half of 2022.

GBP510 is a self-assembling nanoparticle candidate vaccine co-developed by SK bioscience and the University of Washington Institute for Protein Design (IPD), targeting the receptor-binding domain of the SARS-CoV-2 spike protein. According to interim data from the Phase 1/2 clinical trial, volunteers vaccinated with GBP510 exhibited neutralizing antibody titers 5 to 8 times higher than those of COVID-19 convalescent patients, and no safety concerns have been identified to date.

In the latest Phase 3 clinical trial, the two companies expect to enroll approximately 4,000 volunteers globally to evaluate the safety and immunogenicity of GBP510 compared with the COVID-19 vaccine developed by AstraZeneca and the University of Oxford. This study will be one of the first global Phase 3 trials to compare two different COVID-19 candidate vaccines. Subject to positive results and regulatory approval, the vaccine is expected to be supplied globally at scale through the COVAX facility.

As one of the global vaccine giants, it is undoubtedly regrettable that GSK has not yet successfully launched a COVID-19 vaccine, especially given that fellow vaccine leader Pfizer successfully introduced a COVID-19 mRNA vaccine at the end of 2020. This vaccine alone generated $11.3 billion in revenue for Pfizer in the first half of 2021, and as vaccination campaigns continue to roll out globally, the revenue Pfizer derives from its COVID-19 vaccine is expected to sustain its growth.

In fact, GSK did not initiate its vaccine research late. As early as April 2020, GSK partnered with Sanofi to jointly develop a COVID-19 adjuvanted vaccine, leveraging their respective innovative technological strengths. However, the vaccine encountered a setback in 2020 when interim data from the Phase 1/2 study indicated that the immune response in the elderly population fell short of expectations, temporarily delaying its development progress. Following adjustments, the vaccine has now advanced to Phase 3 clinical trials and is expected to receive regulatory approval in the fourth quarter of 2021.

In addition to its collaborations with SK and Sanofi in the field of COVID-19 vaccines, GSK has also partnered with the Canadian biopharmaceutical company Medicago to jointly develop a plant-based COVID-19 vaccine, which is currently in Phase III clinical trials. Additionally, in early February this year, GSK announced a collaboration with CureVac to develop next-generation mRNA COVID-19 vaccines to address the continuously emerging viral variants. In the field of COVID-19 treatment, GSK is working with Vir Biotechnology to develop antiviral antibodies; notably, sotrovimab received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) in May 2021 for the treatment of severe COVID-19 in patients aged 70 years and older.

References:

[1]SK bioscience and GSK start Phase 3 trial of adjuvanted COVID-19 vaccine candidate

[2]GSK, Korean biotech SK go head-to-head against AstraZeneca's COVID-19 shot with their experimental vaccine

[3] GSK-Adjuvanted Recombinant COVID-19 Vaccine Enters Phase III Clinical Trials, Study Previously Delayed Due to Insufficient Immune Response