SKYCovione (GBP510) / SK Bio, GSK - LARVOL DELTA

Safety and immunogenicity of a homologous booster dose of a SARS-CoV-2 recombinant protein nanoparticle vaccine (GBP510) adjuvanted with AS03: 12 months follow-up result of an open-label, non-randomised extension of a phase 1/2 trial. (PubMed, Int J Infect Dis) - "A homologous GBP510/AS03 booster was well tolerated and induced robust, durable neutralising antibody responses against SARS-CoV-2, including Omicron variant."

Journal • P1/2 data • Fatigue • Infectious Disease • Musculoskeletal Pain • Novel Coronavirus Disease • Pain • Respiratory Diseases

Emulsion adjuvant-induced uric acid release modulates optimal immunogenicity by targeting dendritic cells and B cells. (PubMed, NPJ Vaccines) - "Squalene-based emulsion (SE) adjuvants like MF59 and AS03 are used in protein subunit vaccines against influenza virus (e.g., Fluad, Pandemrix, Arepanrix) and SARS-CoV-2 (e.g., Covifenz, SKYCovione)...In an influenza vaccine model, UA contributed to protection against influenza viral infection. These results demonstrate the importance of DAMPs, specifically the versatile role of UA in the immunogenicity of SE adjuvants, by regulating DCs and B cells."

Journal • Infectious Disease • Inflammation • Influenza • Novel Coronavirus Disease • Respiratory Diseases

Immunogenicity and Safety Study of Heterologous Booster Vaccination of a SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine(GBP510) Adjuvanted with AS03 in Adults Aged 18 Years and Older (clinicaltrials.gov) - P3 | N=840 | Completed | Sponsor: SK Bioscience Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Potent neutralization of SARS-CoV-2 variants by RBD nanoparticle and prefusion-stabilized spike immunogens. (PubMed, NPJ Vaccines) - "The vaccine, when adjuvanted with AS03, was shown to elicit robust neutralizing antibody and CD4 T cell responses in Phase I/II clinical trials, met its primary co-endpoints in a Phase III trial, and has been licensed by multiple regulatory authorities under the brand name SKYCovioneTM. The RBD-NP immunogens and HexaPro trimers, as well as combinations of VOC-based immunogens, elicited comparable levels of neutralizing antibodies against distinct VOCs. Our results demonstrate that RBD-NP-based vaccines can elicit neutralizing antibody responses against SARS-CoV-2 variants and can be rapidly designed and stabilized, demonstrating the potential of two-component RBD-NPs as a platform for the development of broadly protective coronavirus vaccines."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4

Immunogenicity and Safety Study of SK SARS-CoV-2 Recombinant Nanoparticle Vaccine (GBP510) Adjuvanted With AS03 (COVID-19) (clinicaltrials.gov) - P3 | N=4036 | Completed | Sponsor: SK Bioscience Co., Ltd. | Active, not recruiting ➔ Completed | Trial primary completion date: Oct 2022 ➔ Oct 2023

Trial completion • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Immunogenicity and safety of SARS-CoV-2 recombinant protein nanoparticle vaccine GBP510 adjuvanted with AS03: interim results of a randomised, active-controlled, observer-blinded, phase 3 trial. (PubMed, EClinicalMedicine) - P3 | "We report interim phase 3 immunogenicity results for GBP510 adjuvanted with AS03 (GBP510/AS03) compared with ChAdOx1-S (Vaxzevria, AstraZeneca) in healthy adults aged ≥18 years, up to 6 months after the second dose. This work was supported, in whole or in part, by funding from CEPI and the Bill & Melinda Gates Foundation Investments INV-010680 and INV-006462. The Bill & Melinda Gates Foundation supported this project for the generation of IND-enabling data and CEPI supported this clinical study."

Journal • P3 data • P3 data: top line • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Immunogenicity and Safety Study of Heterologous Booster Vaccination of a SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine(GBP510) Adjuvanted With AS03 in Adults Aged 18 Years and Older (clinicaltrials.gov) - P3 | N=840 | Active, not recruiting | Sponsor: SK Bioscience Co., Ltd. | Recruiting ➔ Active, not recruiting | Trial primary completion date: Dec 2023 ➔ Aug 2023

Enrollment closed • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4

Immunogenicity and Safety Study of Heterologous Booster Vaccination of a SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine(GBP510) Adjuvanted With AS03 in Adults Aged 18 Years and Older (clinicaltrials.gov) - P3 | N=840 | Recruiting | Sponsor: SK Bioscience Co., Ltd. | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2023 ➔ Aug 2024 | Trial primary completion date: Dec 2022 ➔ Dec 2023

Enrollment open • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4 • IL2 • IL4

Safety and Immunogenicity Study of SARS-CoV-2 Nanoparticle Vaccine (GBP510) Adjuvanted With Aluminum Hydroxide (COVID-19) (clinicaltrials.gov) - P1/2 | N=260 | Completed | Sponsor: SK Bioscience Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IL4

Immunogenicity and protective efficacy of GBP510/AS03 vaccine against SARS-CoV-2 delta challenge in rhesus macaques. (PubMed, NPJ Vaccines) - "Binding and neutralizing antibody responses prior to challenge correlated with protection against viral replication postchallenge. These data are consistent with data with this vaccine from the phase 3 clinical trial."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • KEAP1

Safety, Reactogenicity, and Immunogenicity Study of Heterologous Booster Vaccination of a SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine (GBP510) (clinicaltrials.gov) - P2 | N=770 | Active, not recruiting | Sponsor: Korea University Guro Hospital | Not yet recruiting ➔ Active, not recruiting | N=550 ➔ 770 | Trial completion date: May 2023 ➔ Nov 2023 | Trial primary completion date: Feb 2023 ➔ Aug 2023

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Immunogenicity and Safety Study of SK SARS-CoV-2 Recombinant Nanoparticle Vaccine (GBP510) Adjuvanted With AS03 (COVID-19) (clinicaltrials.gov) - P3 | N=4036 | Active, not recruiting | Sponsor: SK Bioscience Co., Ltd. | Trial completion date: Sep 2022 ➔ Nov 2023 | Trial primary completion date: Mar 2022 ➔ Oct 2022

Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4 • IL2 • IL4

A Phase III Study to Assess the Safety, Reactogenicity, and Immunogenicity of Heterologous Booster Vaccination of a SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine(GBP510) Adjuvanted With AS03 in Adults Aged 18 Years and Older (clinicaltrials.gov) - P3 | N=840 | Not yet recruiting | Sponsor: SK Bioscience Co., Ltd.

New P3 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4

Safety and immunogenicity of a SARS-CoV-2 recombinant protein nanoparticle vaccine (GBP510) adjuvanted with AS03: A randomised, placebo-controlled, observer-blinded phase 1/2 trial. (PubMed, EClinicalMedicine) - P1/2 | "This work was supported, in whole or in part, by funding from CEPI and the Bill & Melinda Gates Foundation Investment ID OPP1148601. The Bill & Melinda Gates Foundation supported this project for the generation of IND-enabling data and CEPI supported this clinical study."

Journal • P1/2 data • Fatigue • Infectious Disease • Musculoskeletal Pain • Novel Coronavirus Disease • Pain • Respiratory Diseases

Immunogenicity and Safety Study of SK SARS-CoV-2 Recombinant Nanoparticle Vaccine (GBP510) Adjuvanted With AS03 (COVID-19) (clinicaltrials.gov) - P3 | N=3990 | Active, not recruiting | Sponsor: SK Bioscience Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4

Safety and Immunogenicity Study of SARS-CoV-2 Nanoparticle Vaccine (GBP510) Adjuvanted With Aluminum Hydroxide (COVID-19) (clinicaltrials.gov) - P1/2 | N=260 | Active, not recruiting | Sponsor: SK Bioscience Co., Ltd. | Trial completion date: Apr 2022 ➔ Jul 2022

Trial completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IL4

Safety, Reactogenicity, and Immunogenicity Study of Heterologous Booster Vaccination of a SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine (GBP510) (clinicaltrials.gov) - P2; N=550; Not yet recruiting; Sponsor: Korea University Guro Hospital

Clinical • New P2 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG

Immunogenicity and Safety Study of SK SARS-CoV-2 Recombinant Nanoparticle Vaccine (GBP510) Adjuvanted With AS03 (COVID-19) (clinicaltrials.gov) - P3; N=3990; Recruiting; Sponsor: SK Bioscience Co., Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4

A Phase III Study to Assess the Immunogenicity and Safety of SK SARS-CoV-2 Recombinant Nanoparticle Vaccine Adjuvanted With AS03 (GBP510) in Adults Aged 18 Years and Older (clinicaltrials.gov) - P3; N=3990; Not yet recruiting; Sponsor: SK Bioscience Co., Ltd.

New P3 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4

Safety and Immunogenicity Study of SARS-CoV-2 Nanoparticle Vaccine (GBP510) Adjuvanted With Aluminum Hydroxide (COVID-19) (clinicaltrials.gov) - P1/2; N=260; Active, not recruiting; Sponsor: SK Bioscience Co., Ltd.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IL4

Safety and Immunogenicity Study of SARS-CoV-2 Nanoparticle Vaccine (GBP510) Adjuvanted With or Without AS03 (COVID-19) (clinicaltrials.gov) - P1/2; N=328; Active, not recruiting; Sponsor: SK Bioscience Co., Ltd.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IL4

Safety and Immunogenicity Study of SARS-CoV-2 Nanoparticle Vaccine (GBP510) Adjuvanted With Aluminum Hydroxide (COVID-19) (clinicaltrials.gov) - P1/2; N=260; Recruiting; Sponsor: SK Bioscience Co., Ltd.

Clinical • New P1/2 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IL4

Safety and Immunogenicity Study of SARS-CoV-2 Nanoparticle Vaccine (GBP510) Adjuvanted With or Without AS03 (COVID-19) (clinicaltrials.gov) - P1/2; N=320; Recruiting; Sponsor: SK Bioscience Co., Ltd.

Clinical • New P1/2 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IL4

SK Bioscience's COVID-19 Vaccine to Get CEPI’s Funding - "'We are pleased to have entered into a partnership with SK Bioscience to develop GBP510,' CEPI CEO Richard Hatchett said. 'The vaccine is the treatment that the Wave2 project has invested in, and we believe it will become a good option in overcoming the coronavirus.'"

Grant • Media quote

CEPI and SK bioscience extend collaboration to develop ‘next generation’ COVID-19 vaccine - "I'm pleased to expand our partnership with SK bioscience to develop their vaccine candidate, GBP510, which marks CEPI's first investment in 'Wave 2' vaccines. Going forwards, developing these cutting-edge 'Wave 2' vaccines will expand our armamentarium against COVID-19 and enable the use of vaccines in a wider range of settings and populations, providing the world with additional options to control this deadly disease - Dr. Richard Hatchett."

Media quote