Sanofi and GlaxoSmithKline look set to agree a £500m deal with Britain for the supply of 60 million doses of a potential COVID-19 vaccine, according to a report from the Sunday Times.

Last month, French drugmaker Sanofi said that it expects to start clinical testing of its experimental coronavirus vaccine in September, several months earlier than planned. The company added that it could have the vaccine ready for emergency use by as early as January.

According to the Sunday Times report, Britain is considering agreeing an option to buy the vaccine if it proves effective in human trials, and would pay the £500m total in stages.

Sanofi is investigating two vaccine candidates, one of which uses GSK’s AS03 adjuvant and is based on Sanofi’s baculovirus expression system, already used in its quadrivalent flu vaccine. The other candidate, which Sanofi is developing with Translate Bio, leverages mRNA technology against the novel coronavirus disease.

The Sanofi/GSK deal would be the second such deal Britain has made for the assured supply of a potential coronavirus vaccine, following a similar deal made with AstraZeneca for access to Oxford University’s candidate.

A spokeswoman for Britain’s business ministry said that “the Government’s Vaccines Task Force is actively engaging with a wide range of companies both in the UK and abroad to negotiate access to vaccines”, although she did not confirm if GSK and Sanofi were involved in these negotiations.
In April, the UK government set out its plans for a new coronavirus vaccine task force, which was created to support efforts to rapidly develop a vaccine by providing industry and research institutions the resources and support they need.

Governments across the world are scrambling to agree deals for potential vaccines and treatments for COVID-19 as confirmed cases and deaths continuing to climb. Concerns have been raised that these deals could inhibit equitable access to transformative treatments, allowing high-income countries to secure supplies of potential therapeutics while preventing low-income countries from doing so.

However, certain initiatives, including the World Health Organization’s (WHO) Access to COVID-19 Tools (ACT) Accelerator, are focusing on ‘equitable distribution of the tests, treatments and vaccines the world needs to reduce mortality and severe disease’.

The accelerator is jointly led and funded by the Bill & Melinda Gates Foundation, CEPI, FIND, Gavi, The Global Fund, Unitaid, Wellcome, the WHO and the World Bank.

Regeneron has advanced its investigational double antibody cocktail for COVID-19 into a phase 3 trial, following positive results in earlier studies.

The study, which is being run jointly with the US National Institute of Allergy and Infectious Diseases (NIAID), will evaluate REGN-COV2’s ability to prevent infection among uninfected people who have had close exposure to a COVID-19 patient.

The antibody cocktail has also moved into the phase 2/3 arm of two adaptive phase 1/2/3 trials testing its ability to effectively treat hospitalised and non-hospitalised COVID-19 patients.

The phase 3 prevention trial is set to be conducted at around 100 sites across the US, and will enrol approximately 2,000 patients with the aim of assessing SARS-CoV-2 infection status. Meanwhile, the two phase 2/3 treatment trials are planned to be conducted at approximately 150 sites in the US, Brazil, Mexico and Chile, and will evaluate virologic and clinical endpoints.

According to Regeneron, preliminary data from these trials is expected later this summer, adding in a statement that the ultimate numbers of patients enrolled will depend on trial progress and insights from phase 2 studies.

The progress of REGN-COV2 is welcome news for Regeneron, after it had to abandon its Sanofi-partnered study of Kevzara (sarilumab) following disappointing results in a phase 3 trial. The two companies had been investigating the rheumatoid arthritis drug in mechanically ventilated COVID-19 patients, but data from that study found the drug was unable to prevent death or help patients come off ventilation.

Another IL-6 inhibitor, Roche’s Actemra (tocilizumab), also produced poor results in an Italian study, in which the drug was also unable to improve patients’ severe respiratory symptoms or reduce mortality rates when compared to standard-of-care treatment.

With Kevzara falling by the wayside, Regeneron is now pinning its hopes on REGN-COV2, highlighting its potential to diminish the risk of viral escape as a reason to advance the drug into large-scale human studies.

The process of viral escape occurs when spontaneously arising mutant forms of a virus are able to evade a therapeutic’s blocking action, when that virus is under pressure from said antiviral therapeutic. These mutant forms are then often able to survive and proliferate and may ultimately become the dominant strain of the virus.

Quebec, Canada-based biotech Medicago has started phase 1 clinical trials for its plant-derived COVID-19 vaccine candidate, administering the first doses in healthy human volunteers.

Medicago’s uses Virus-Like Particles (VLPs), rather than animal products or live viruses, to create its products. VLPs mimic the shape and dimensions of a virus, allowing the body to recognise them and create an immune response. Previous clinical trial data suggests that VLPs have a ‘multimodal’ mechanism of action that works differently from inactivated vaccines, by activating both arms of the immune system – antibody and cell-mediated response.

The company’s COVID-19 vaccine candidate, a recombinant coronavirus VLP (CoVLP), will be tested in a randomised, partially blinded study of 180 normal healthy subjects aged 18-55. It will evaluate three dosages – 3.75, 7.5 or 15 micrograms and the vaccine will be either administered on its own or with an adjuvant in a prime-boost regimen.

Medicago will be evaluating its CoVLP vaccine candidate alongside two adjuvants, separately – GlaxoSmithKline’s proprietary pandemic adjuvant technology and Dynanvax’s CpG 1018. Last week, GSK and Medicago signed a deal to jointly develop and evaluate the CoVLP candidate, with the companies agreeing to share the cost of development and manufacturing, if it proves to be effective in human subjects.

In a preclinical study of CoVLP, the candidate demonstrated a high level of neutralising antibodies, following a single dose when administered with an adjuvant. Adjuvants are thought to be particularly useful in pandemic situations, as they can boost immune response and reduce the amount of antigen required per dose, allowing more vaccine doses to be manufactured and distributed.

If all goes to plan, Medicago envisions a large-scale phase 2/3 trial to begin as early as October, and also expects to be able to manufacture around 100 million doses by the end of 2021. Following the completion of Medicago’s large-scale facility in Quebec City in 2023, the company expects to have capacity to produce up to one billion doses of its COVID-19 vaccine annually.
Medicago has already completed a phase 3 clinical trial of a quadrivalent VLP influenza vaccine candidate and phase 2 clinical trials of an H1N1 pandemic vaccine candidate, both using its plant-based manufacturing technology. The company’s flu vaccine is currently under review with Health Canada, following the completion of a safety and efficacy clinical programme in over 25,000 subjects.

The US government has committed a massive $1.6bn in funding to late-stage biotech company Novavax for the accelerated development of its investigational coronavirus vaccine.

The deal is the latest in a string of agreements made by the federal government under its Operation Warp Speed scheme, which was created earlier this year to aid the development and manufacture of promising coronavirus vaccines.

The agreement with Novavax is the largest to date, and under its terms the biotech company will produce 100 million doses of its vaccine by the beginning of 2021, if its proven to be safe and effective in clinical testing.

The money will also go towards completing late-stage clinical development and establishing large-scale manufacturing for Novavax’ experimental candidate, NVX-CoV2373. That includes a pivotal phase 3 trial with up to 30,000 participants set to begin in autumn this year.

The agreement also allows for an add-on agreement with the US government for the additional production and procurement of Novavax’ vaccine to further support Operation Warp Speed’s goal of delivering 300 million doses of a safe, effective vaccine for COVID-19 by January 2021.

An initial phase 1/2 trial of NVX-CoV2373 began in Australia in May, testing the vaccine in 130 healthy participants between the ages of 18 and 59 years. According to Novavax, preliminary immunogenicity and safety results are expected by the end of the month, and the phase 2 portion to assess immunity, safety and COVID-19 disease reduction is set to begin shortly after that.

The US government has now invested almost $4bn to help pharma and biotech companies develop coronavirus vaccines, although little is known about how exactly Operation Warp Speed is spending the money or how decisions are being made, according to The New York Times.

So far, that funding has gone to six companies, including AstraZeneca, Moderna, Merck, Sanofi and Johnson & Johnson’s Janssen division. These companies are at varying stages of development, and also differ in their experience in bringing a successful product to market.