Lilly, Vir Biotechnology and GSK Announce First Patient Dosed in Expanded BLAZE-4 Trial Evaluating Bamlanivimab (LY-CoV555) with VIR-7831 (GSK4182136) for COVID-19
27 January 2021 -- Eli Lilly and Company (NYSE: LLY), Vir Biotechnology, Inc. (NASDAQ: VIR) and GlaxoSmithKline plc (LSE/NYSE: GSK) today announced a collaboration to evaluate a combination of two COVID-19 therapies in low-risk patients with mild to moderate COVID-19. Lilly has expanded its ongoing BLAZE-4 trial to evaluate the administration of bamlanivimab (LY-CoV555) 700mg with VIR-7831 (also known as GSK4182136) 500mg, two neutralising antibodies that bind to different epitopes of the SARS-CoV-2 spike protein. This unique collaboration marks the first time that monoclonal antibodies from separate companies will be brought together to explore potential outcomes.
Bamlanivimab is a neutralising antibody directed against the spike protein of SARS-CoV-2 designed to block viral attachment and entry into human cells, thus neutralising the virus. Bamlanivimab emerged from the collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of COVID-19. Bamlanivimab is authorised for emergency use for the treatment of mild to moderate COVID-19 in patients who are at high risk for progressing to severe COVID-19 and/or hospitalisation.
VIR-7831 is a dual-action monoclonal antibody that was selected for clinical development based on its potential to both block viral entry into healthy cells and clear infected cells, as well as its potential to provide a high barrier to resistance. In pre-clinical trials, the antibody has shown the ability to neutralise the SARS-CoV-2 live virus by binding to an epitope on SARS-CoV-2 shared with SARS-CoV-1, indicating that the epitope is highly conserved, which may make it more difficult for escape mutants to develop. Vir and GSK are advancing VIR-7831 as part of their collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2.
Daniel Skovronsky, M.D., Ph.D., Lilly’s chief scientific officer and president at Lilly Research Laboratories said: “Bamlanivimab is a potent antibody – with data from multiple Phase 2 and 3 clinical trials, which have demonstrated robust evidence for both treating and preventing COVID-19. With a virus like SARS-CoV-2, it’s expected that variants could emerge that require new therapeutic options, which is why Lilly is studying bamlanivimab together with other neutralising antibodies, including etesevimab. Adding VIR-7831 to our study is an important part of our commitment to develop therapies to treat current and future strains of COVID-19 until vaccines are widely available and utilised.”
George Scangos, Ph.D., chief executive officer at Vir said: “We believe that VIR-7831 has significant potential as a single agent, and we are optimistic about the pending interim data from two Phase 3 trials evaluating its potential for early treatment and in hospitalised patients. As the virus continues to evolve, we, along with Lilly and GSK, share the view that we should pursue all possibilities to help end the pandemic and maximise the number of lives that can be saved. This trial is a first step to assess whether the administration of VIR-7831, with its high barrier to resistance and potent effector function, alongside bamlanivimab, which has strong outcomes data in early treatment, can provide potential benefits beyond monotherapy.”
Dr. Hal Barron, chief scientific officer and president R&D at GSK said: “Despite the significant progress on vaccines, there remains an urgent patient need for multiple therapeutic approaches to help prevent the severe consequences of COVID-19. Partnering with Lilly to study VIR-7831 with bamlanivimab will provide the scientific community with further data on the important role these therapies could play in reducing the impact of this devastating pandemic.”
Bamlanivimab alone has been granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) based on interim data from the Phase 2 BLAZE-1 trial, which was published in the New England Journal of Medicine. These data show the therapy may help patients clear the virus and reduce COVID-19-related hospitalisations when given early in the disease course. The safety and efficacy of bamlanivimab is being evaluated with other neutralising antibodies to provide a possible safeguard against potential viral resistance.
VIR-7831 is an investigational compound, not approved by the U.S. FDA or any other regulatory authority. VIR-7831 is also being evaluated in the global Phase 2/3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) trial for the early treatment of COVID-19 in adults at high risk of hospitalisation.
BLAZE-4 (NCT04634409) is a randomized, double-blind, placebo-controlled trial designed to assess the efficacy and safety of bamlanivimab alone, and bamlanivimab with other neutralising antibodies including VIR-7831 (GSK4182136) versus placebo for the treatment of symptomatic COVID-19 in the outpatient setting. Across all treatment arms, the trial will enroll an estimated 1,000 participants in the United States and Puerto Rico.
The primary outcome measure is percentage of participants who have a viral load greater than 5.27 at day 7. Additional endpoints include change from baseline to day 7 in SARS-CoV-2 viral load, percentage of participants who experience COVID-related hospitalisation, ER visit or death from baseline through day 29, as well as safety.
Bamlanivimab is a recombinant, neutralising human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. It is designed to block viral attachment and entry into human cells, thus neutralising the virus, potentially treating COVID-19. Bamlanivimab emerged from the collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of COVID-19. Lilly scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. It was identified from a blood sample taken from one of the first U.S. patients who recovered from COVID-19.
Lilly has successfully completed a Phase 1 study of bamlanivimab in hospitalised patients with COVID-19 (NCT04411628). A Phase 2/3 study in people recently diagnosed with COVID-19 in the ambulatory setting (BLAZE-1 NCT04427501) is ongoing. A Phase 3 study of bamlanivimab for the prevention of COVID-19 in residents and staff at long-term care facilities (BLAZE-2, NCT04497987) is ongoing. In addition, bamlanivimab is being tested in the National Institutes of Health-led ACTIV-2 study in ambulatory COVID-19 patients.
Bamlanivimab is authorized in the U.S. for the treatment of mild to moderate COVID-19 in adults and pediatric patients 12 years and older with a positive COVID-19 test, who are at high risk for progressing to severe COVID-19 and/or hospitalization. Bamlanivimab should be administered as soon as possible after a positive COVID-19 test and within 10 days of symptom onset.
Etesevimab (LY-CoV016, also known as JS016) is a recombinant, fully human monoclonal neutralising antibody, which specifically binds to the SARS-CoV-2 surface spike protein receptor binding domain with high affinity and can block the binding of the virus to the ACE2 host cell surface receptor. Point mutations were introduced into the native human IgG1 antibody to mitigate effector function. Lilly licensed etesevimab from Junshi Biosciences after it was jointly developed by Junshi Biosciences and Institute of Microbiology, Chinese Academy of Science (IMCAS). Junshi Biosciences leads development in Greater China, while Lilly leads development in the rest of the world.
Lilly has successfully completed a Phase 1 study (NCT04441931) of etesevimab in healthy U.S. volunteers to evaluate the safety, tolerability, pharmacokinetics and immunogenicity. A Phase 2/3 study in people recently diagnosed with COVID-19 in the ambulatory setting (BLAZE-1, NCT04427501) is ongoing. Junshi Biosciences has completed a similar Phase 1 study in healthy volunteers in China and has initiated Phase 1b/2 trials in COVID-19 patients globally.
About VIR-7831 / GSK4182136
VIR-7831 (GSK4182136) is an investigational dual-action monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus which causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7831 also has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life.
The COMET clinical development program for VIR-7831 includes a planned Phase 3 trial for the prevention of symptomatic infection. VIR-7831 is also being evaluated in a sub-trial of the National Institutes of Health’s (NIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Program Phase 3 clinical trial. This trial is designed to evaluate the safety and efficacy of VIR-7831 for the treatment of hospitalized adults with COVID-19.
About Lilly’s COVID-19 Efforts
Lilly is bringing the full force of its scientific and medical expertise to attack the coronavirus pandemic around the world. Existing Lilly medicines are being studied to understand their potential in treating complications of COVID-19, and the company is collaborating with partner companies to discover novel antibody treatments for COVID-19. Lilly is testing both single antibody therapy as well as combinations of antibodies as potential therapeutics for COVID-19. Visit Lilly’s COVID-19 disease area page for resources related to Lilly's COVID-19 efforts.
GSK commitment to tackling COVID-19
GSK’s response to COVID-19 has been one of the broadest in the industry with potential treatments and vaccine candidates in development.
GSK is collaborating with several organisations working on promising COVID-19 vaccines by providing access to our adjuvant technology. In a collaboration with Sanofi that brings together two of the world’s largest vaccine companies, GSK is developing an adjuvanted recombinant protein-based COVID-19 vaccine candidate with a phase 2b study expected to start in February 2021. GSK also is collaborating with Medicago and Clover Biopharmaceuticals on adjuvanted, protein-based vaccine candidates, which are progressing into late-stage clinical trials. The use of an adjuvant is of particular importance in a pandemic situation since it may reduce the amount of vaccine protein required per dose, allowing more vaccine doses to be produced and therefore contributing to protecting more people.
GSK is also exploring potential therapeutic or treatment options for COVID-19 patients. We are collaborating with Vir Biotechnology to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. Currently, we are collaborating on the phase 3 clinical development of VIR-7831 (GSK4182136), a dual-action monoclonal antibody that has shown the ability in preclinical trials to both neutralise SARS-CoV-2 live virus in vitro and in vivo and kill already infected cells.
About Eli Lilly and Company
Lilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and www.lilly.com/news.
About Vir Biotechnology
Vir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting hepatitis B virus, influenza A, SARS-CoV-2, human immunodeficiency virus and tuberculosis. For more information, please visit www.vir.bio.
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 www.gsk.com/about-us.
Posted: January 2021