REG - GlaxoSmithKline PLC - GSK/Sanofi COVID-19 vaccine booster & Ph3 update

GSKAnnouncement

15/12/2021 07:00

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RNS Number : 7153V  GlaxoSmithKline PLC  15 December 2021

Issued: 15 December 2021, London, UK

 

GSK and Sanofi announce positive preliminary booster data for their COVID-19
vaccine candidate and continuation of phase III trial per independent
Monitoring Board recommendation

 

·    Positive booster data show that neutralising antibodies increased
across all primary vaccines received (mRNA or adenovirus) in a 9- to 43-fold
range and for all age groups tested, with a good safety and tolerability
profile

·    Phase III trial continues to accrue the number of events needed for
analysis as populations around the world are increasingly exposed to COVID-19
variants; results expected in Q1 2022

·    Companies intend to file booster data with regulatory authorities
following the phase III results

 

 

GlaxoSmithKline plc (LSE/NYSE: GSK) and Sanofi announced today that a single
booster dose of their recombinant adjuvanted COVID-19 vaccine candidate
delivered consistently strong immune responses.

 

Preliminary results from the VAT0002 clinical trial investigating the safety
and immunogenicity of the booster showed neutralising antibodies increased 9-
to 43-fold regardless of the primary vaccine received (AstraZeneca, Johnson
& Johnson, Moderna, Pfizer/BioNTech) and for all age groups tested. The
booster was well tolerated, with a safety profile similar to currently
approved COVID-19 vaccines. This is the most comprehensive booster trial to
date to explore boosting across different vaccine technologies used for
primary vaccination.

 

The ongoing global phase III trial, VAT0008, includes regular reviews by an
independent Data Safety Monitoring Board (DSMB). During its last review, the
DSMB identified no safety concerns and recommended the trial to continue into
early 2022 to accrue more data.

 

Regulatory authorities require phase III efficacy to be demonstrated in naïve
populations, i.e. participants who have never been infected by the COVID-19
virus (seronegative). The phase III trial recruited most participants in Q3
2021, coinciding with a significant increase in the number of people infected
by the COVID-19 virus globally due to the Delta variant. To provide the
necessary data to regulatory authorities for the booster vaccine submission,
the trial will continue to accrue the number of events needed for analysis,
with results expected in Q1 2022.

 

"These preliminary data show we have a strong booster candidate, whatever
primary vaccine you have received," said Thomas Triomphe, Executive Vice
President, Sanofi Pasteur. "This is consistent with our efforts to provide
relevant responses to evolving public health needs. While pursuing a phase III
trial is a challenge in a quickly shifting pandemic environment, we look
forward to seeing the results to support submissions of our booster vaccine as
quickly as possible."

 

Roger Connor, President of GSK Vaccines, added: "As the pandemic threat
continues with the current dominant Delta variant and Omicron rapidly gaining
ground, booster vaccines will continue to be needed to help protect people
over time. The initial booster data are promising, and we await the phase III
results to determine the next steps on making protein-based adjuvanted
COVID-19 vaccines available."

 

About the booster trial (VAT0002)

The VAT0002 extension trial is the most comprehensive heterologous booster
trial conducted to date. In the first cohort of this trial, the four most
widely approved COVID-19 primary vaccines using mRNA and adenovirus vector
technologies were boosted with the Sanofi/GSK protein-based adjuvanted vaccine
candidate after full primary vaccination to assess its safety profile and
immunogenicity.

 

Participants in the first cohort (n=521) had previously been vaccinated with
the approved dosing schedule of an authorised COVID-19 mRNA vaccine (Moderna,
Pfizer/BioNTech) or adenovirus vector vaccine (AstraZeneca, Johnson &
Johnson). This preliminary analysis includes data from trial participants who
received one 5µg booster dose of the adjuvanted recombinant protein vaccine
targeting the D614 parent virus, between four and ten months after a complete
primary vaccination schedule.

 

The trial is ongoing across sites in multiple countries, including the US,
France, and the UK. To address the emergence of COVID-19 variants of concern,
additional trial cohorts are assessing the boosting potential of monovalent
and bivalent vaccine formulations also containing the Beta (B.1.351) variant.
More data from this trial are expected during the first half of 2022. The
Omicron variant was not circulating during the trial. Using sera from booster
trial participants, testing is underway to establish the ability of the
vaccine candidate to cross-neutralize against Omicron.

 

About the phase III efficacy trial (VAT0008)

The primary endpoint of this ongoing phase III, randomised, double-blind,
placebo-controlled trial is the prevention of symptomatic COVID-19 in
SARS-CoV-2 naïve adults, with secondary endpoints of preventing severe
COVID-19 disease and infection. Stage one of the trial is assessing the
efficacy of a vaccine formulation containing the spike protein against the
original D614 (parent) virus in more than 10,000 participants >18 years of
age, randomised to receive two doses of 10µg vaccine or placebo at day one
and day 22 across sites in the US, Asia, Africa and Latin America. A second
stage in the trial is evaluating a second bivalent formulation, adding the
spike protein of the B.1.351 (Beta) variant.

 

These efforts are supported by federal funds from the Biomedical Advanced
Research and Development Authority, part of the office of the Assistant
Secretary for Preparedness and Response at the US Department of Health and
Human Services in collaboration with the US Department of Defense Joint
Program Executive Office for Chemical, Biological, Radiological and Nuclear
Defense under Contract # W15QKN-16-9-1002.

 

About the GSK / Sanofi collaboration

In the collaboration between the two companies, GSK contributes its pandemic
adjuvant, and Sanofi provides its recombinant antigen, both established
vaccine platforms that have proven successful against influenza.

 

GSK commitment to tackling COVID-19

GSK's response to COVID-19 has been one of the broadest in the industry, with
potential treatments in addition to our vaccine candidates in development with
partner organisations.

 

GSK is collaborating with several organisations on COVID-19 vaccines by
providing access to our adjuvant technology. We are working with Sanofi,
Medicago and SK bioscience to develop adjuvanted, protein-based vaccine
candidates. The use of an adjuvant can be of particular importance in a
pandemic since it may reduce the amount of vaccine protein required per dose,
allowing more vaccine doses to be produced and contributing to protecting more
people in need.

 

GSK is also working with mRNA specialist CureVac N.V. to jointly develop
next-generation, optimised mRNA vaccines for COVID-19 with the potential to
address multiple emerging variants in one vaccine.

 

GSK is also exploring treatments for COVID-19 patients, collaborating with Vir
Biotechnology to investigate monoclonal antibodies that could be used as
therapeutic or preventive options for COVID-19.

 

About Sanofi

Sanofi is dedicated to supporting people through their health challenges. We
are a global biopharmaceutical company focused on human health. We prevent
illness with vaccines, provide innovative treatments to fight pain and ease
suffering. We stand by the few who suffer from rare diseases and the millions
with long-term chronic conditions.

 

With more than 100,000 people in 100 countries, Sanofi is transforming
scientific innovation into healthcare solutions around the globe.

 

Sanofi, Empowering Life

 

About GSK

GSK is a science-led global healthcare company. For further information please
visit www.gsk.com/about-us (https://www.gsk.com/en-gb/about-us/) .

 

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                              Frannie DeFranco  +1 215 751 4855       (Philadelphia)

 

Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made
by GSK, including those made in this announcement, are subject to risks and
uncertainties that may cause actual results to differ materially from those
projected. Such factors include, but are not limited to, those described in
the Company's Annual Report on Form 20-F for 2020, GSK's Q3 Results and any
impacts of the COVID-19 pandemic.

 

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References

1. Moderna: VRBPAC briefing document, 14 October 2021. Accessed
17/11/21.Available at: Vaccines and Related Biological Products Advisory
Committee October 14-15, 2021 Meeting Briefing Document- Sponsor (Moderna)
(fda.gov) (https://www.fda.gov/media/152953/download)

2. Pfizer: VRBPAC briefing document, 17 September 2021. Accessed
17/11/21.Available at: Vaccines and Related Biological Products Advisory
Committee September 17, 2021 Meeting Briefing Document- Sponsor (fda.gov)
(https://www.fda.gov/media/152161/download)

 

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