Sanofi and GlaxoSmithKline (GSK) said today they have launched a Phase I/II trial assessing their COVID-19 vaccine in up to 440 healthy adults—one of several vaccines against the virus whose development is being funded by the U.S. government.

The Phase I/II trial is a randomized, double blind and placebo-controlled study designed to evaluate the safety, tolerability, and immunogenicity of the COVID-19 vaccine candidate. The 440 healthy adults are being enrolled across 11 investigational sites in the U.S.

Sanofi and GSK said they anticipate first results in early December 2020, when the companies expect to launch a Phase III trial. Should the data prove positive, Sanofi and GSK said, they plan to request regulatory approval for their vaccine in the first half of 2021.

“Our dedicated teams and partner continue to work around the clock as we aim to deliver the first results in early December,” Thomas Triomphe, executive VP and Global Head of Sanofi Pasteur, Sanofi’s vaccine business, said in a statement. “Positive data will enable a prompt start of the pivotal Phase III trial by the end of this year.”

Sanofi is leading clinical development and registration efforts for the vaccine.

The Sanofi/GSK vaccine combines Sanofi’s S-protein COVID-19 antigen, which is based on recombinant DNA technology, and GSK’s pandemic AS03 adjuvant. The vaccine is one of 19 “Front Runner” candidates among the nearly 300 COVID-19 therapeutics included in GEN’s updated “COVID-19 Drug & Vaccine Candidate Tracker.”

Pre-clinical results for the vaccine will be published later this year. According to the companies, their preclinical data showed an acceptable reactogenicity profile and data based on two injections of the adjuvanted recombinant vaccine showed high levels of neutralizing antibodies that are comparable to levels in humans who recovered from the COVID-19 infection.

In parallel with the trial, Sanofi and GSK said, they are scaling up manufacturing of the antigen and adjuvant with the target of producing up to one billion doses in 2021.

$2.1B via “Warp Speed”

On July 31, Sanofi and GSK joined the U.S. Departments of Health and Human Services (HHS) and Defense (DoD) to announce that the companies were awarded up to $2.1 billion by the U.S. government toward developing and manufacturing their COVID-19 vaccine.

HHS and DoD are providing the funding through Operation Warp Speed, the program by which President Donald Trump’s administration has committed the nation to delivering 300 million vaccine doses protecting against SARS-CoV-2 by January 2021.

Operation Warp Speed funds and coordinates development of vaccines, drugs, and diagnostics across agencies of DoD and HHS—the latter agency including the FDA, the NIH, the Centers for Disease Control and Prevention (CDC), and the Biomedical Advanced Research and Development Authority (BARDA).

Sanofi will receive the majority of the U.S. government funding, more than half of which is intended to support late-stage development of the vaccine, including a large-scale Phase III efficacy trial and other clinical studies, with the rest to be used toward manufacturing scale-up and delivery of an initial 100 million doses of the vaccine. The U.S. government has an option for the supply of an additional 500 million doses.

The companies have agreed to carry out fill-finish manufacturing in the United States so that vaccine doses are packaged and ready to ship immediately if clinical trials are successful and FDA authorizes use.

Manufacturing demonstration

While clinical trials are underway, HHS said, manufacturing efforts would begin with a demonstration project intended to speed up vaccine development.

Sanofi and GSK also agreed in July to supply up to 60 million doses of their COVID-19 vaccine to the U.K. government.

In addition, GSK and Sanofi restated today that they plan to provide a “significant” portion of their total worldwide available supply capacity in 2021 and 2022 to “Access to COVID‐19 Tools (ACT) Accelerator,” a global collaboration designed to accelerate development, production, and equitable access to COVID-19 tests, treatments, and vaccines.

The World Health Organization is among global organizations in the ACT collaboration, along with the Bill & Melinda Gates Foundation; the Coalition for Epidemic Preparedness Innovations (CEPI); the Foundation for Innovative New Diagnostics (FIND); Gavi, The Vaccine Alliance; The Global Fund; Unitaid; Wellcome; The World Bank; and the World-Bank-supported Global Financing Facility.

Other partners

“Moving this vaccine candidate into clinical development is an important moment in the progress towards addressing the global pandemic we are all facing,” added Roger Connor, president of GSK Vaccines added. “This builds on the confidence shown by governments already in the potential of this protein-based adjuvanted vaccine candidate, which utilizes established technology from both companies, and can be produced at scale by two of the leading vaccine manufacturers globally.”

Sanofi is the second partner with which GSK is trying to develop a COVID-19 vaccine. On Monday, GSK joined Vir Biotechnology in dosing the first patient in the Phase II/III COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial—Intent to Care Early) study, designed to evaluate whether VIR-7831, as a single-dose monoclonal antibody, can prevent hospitalization in patients with mild or moderate forms of COVID-19 who are at high risk of progression to severe disease, such as the elderly or those with pre-existing conditions such as lung or heart disease.

Sanofi is also developing a COVID-19 vaccine with another partner, Translate Bio, using mRNA technology. That partnership expanded in June to include the disease among infectious diseases targeted, with the pharma giant nearly tripling to more than $2.3 billion its potential payout to the Lexington, MA, biotech. The companies have said they aim to launch a first-in-human clinical trial of the COVID-19 vaccine in the fourth quarter.

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