UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR
15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the
month of May 2023
Commission
File Number 001-15170
GSK plc
(Translation
of registrant's name into English)
980 Great West Road, Brentford, Middlesex, TW8 9GS
(Address
of principal executive office)
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F . . . .X. . . . Form 40-F . . . . . . . .
Issued: 12 May 2023, London UK
GSK presents pivotal data at ESPID confirming effectiveness of its
5-in-1 meningococcal ABCWY vaccine candidate, with demonstrated
coverage against a panel of 110 MenB strains
●
Preliminary results from phase
III trial show all primary endpoints met, demonstrating statistical
non-inferiority compared to Bexsero (meningococcal
group B vaccine) and Menveo (meningococcal
group A, C, W-135, and Y conjugate vaccine), in individuals
10-25 years old with an acceptable safety
profile
●
Only
investigational 5-in-1 vaccine with demonstrated immunological
effectiveness against 110 diverse MenB invasive strains in a
clinical trial
●
If
approved, this vaccine candidate could provide the broadest
coverage against the most prevalent meningococcal serogroups and
could lead to a simplified immunisation schedule
GSK plc (LSE/NYSE: GSK) today presented preliminary positive results from the
phase III trial (https://clinicaltrials.gov/ct2/show/NCT04502693)
evaluating the immunological vaccine effectiveness and safety of
its MenABCWY combination vaccine
candidate, administered as two doses given
six months apart in
healthy individuals aged 10-25 years. The preliminary data were
disclosed at the 41st Annual Meeting of the European Society for
Paediatric Infectious Diseases (ESPID) in Lisbon,
Portugal.
The vaccine candidate demonstrated non-inferiority in primary
endpoints for five Neisseria
meningitidis serogroups (A, B, C, W, and
Y) compared to two doses of Bexsero (meningococcal
group B vaccine) and one dose of Menveo (meningococcal
group A, C, W-135, and Y conjugate vaccine) in 10-25-year-olds. In
addition, the vaccine candidate was generally well tolerated, with
a safety profile consistent with Bexsero and Menveo. In
a separate confirmatory arm of this phase III trial, the MenABCWY
vaccine candidate showed immunological effectiveness against a panel of
110 diverse meningococcal serogroup B
(MenB) invasive strains, which account for 95% of strains
circulating in the US.[1]
Tony Wood, Chief Scientific Officer at GSK,
said: "These
preliminary data further unlock the potential of our MenABCWY
vaccine candidate in providing protection against invasive
meningococcal disease caused by serogroups A, B, C, W and Y. It's
particularly encouraging to see the breadth of coverage against the
broadest panel of circulating MenB strains to date, as we
know MenB
is the most common cause of meningococcal disease in the US with
the lowest immunisation rate."
Five Neisseria
meningitidis serogroups
(A, B, C, W, and Y) account for nearly all invasive meningococcal
disease (IMD) cases in most of the world.[2] Meningitis
B is currently the most common serogroup in the US and accounts for
more than half of meningococcal disease cases among
16-20-year-olds.[3],[4] Currently
immunisation coverage rates for Men B are estimated at
approximately 31% of adolescents in the US.[5] GSK's
MenABCWY vaccine candidate combines the antigenic components of
licensed meningococcal vaccines, Bexsero and Menveo. The aim of combining two effective vaccines into
one is to help simplify immunisation schedules, which can in turn
increase vaccination coverage and help reduce the overall burden of
disease.
Professor Terry Nolan, principal investigator for the phase III
trial, and Head of the Vaccine and Immunisation Research Group at
the Peter Doherty Institute for Infection and Immunity at the
University of Melbourne, and Murdoch Children's Research Institute,
said: "Meningococcal
vaccination can help save lives and these results are significant
in moving one step closer to protection against five meningococcal
serogroups with a single vaccine. The potential for a simplified
immunisation schedule could improve accessibility for the target
population susceptible to meningococcal
disease."
GSK is working closely with regulatory agencies to review the full
phase III data set, including the supplemental Biologics License
Application for Bexsero for confirmation of full licensure under the
Accelerated Approval pathway. Detailed results will be submitted
for publication in a peer-reviewed scientific journal later this
year.
About the MenABCWY phase III trial
The trial conducted by GSK is a phase III randomised, controlled,
observer-blind, multi-country trial to evaluate the safety,
tolerability, and immunogenicity of GSK's MenABCWY vaccine
candidate. It
is part of a comprehensive programme to generate clinical evidence
on the benefits of meningococcal immunisation. The trial started in August 2020, and
approximately 3,650 participants aged 10-25 were enrolled in the
US, Canada, Czech Republic, Estonia, Finland, Turkey, and
Australia.
The objective of the trial was to assess the safety profile of the
MenABCWY vaccine candidate, to assess the immunological vaccine
effectiveness against a panel of 110 MenB strains, and to compare
the immune responses of the trial's participants who received two
doses of the MenABCWY vaccine candidate six months apart to the
responses of those in the control groups who received GSK's
licensed vaccines, Bexsero (MenB)
and one dose of Menveo (MenACWY). There
are a total of 11 primary endpoints for the trial, five for
MenABCWY and six for Bexsero. Bexsero is
used as the comparator for the MenB immune responses
induced by the MenABCWY vaccine in the trial, which
is both the phase III trial for MenABCWY and confirmatory trial
for Bexsero in
the US.
About Bexsero
Bexsero is
currently licensed or has received regulatory approval in over 50
countries, including the US and EU, and is used in 13 national
immunisation programmes worldwide for the prevention of IMD caused
by Neisseria
meningitidis serogroup
B. Bexsero is
the only MenB vaccine with trials that have demonstrated a
reduction in IMD, including vaccine effectiveness in real-world
settings. Regulatory approvals vary by country. It is approved for
individuals two months of age and older in
Europe.
In the US, Bexsero is
licensed under the Accelerated Approval pathway for
active immunisation to prevent IMD caused
by Neisseria
meningitidis serogroup B in individuals
from 10 through 25 years. Approval
of Bexsero is
based on demonstrating an immune response, as measured by serum
bactericidal activity against three serogroup B strains
representative of prevalent strains in the US. The effectiveness
of Bexsero against
diverse serogroup B strains has not been
confirmed.
Please see the
US Prescribing Information:
https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Bexsero/pdf/BEXSERO.PDF
About Menveo
Menveo vaccine
for meningococcal groups A, C, Y, and W has received regulatory
approval in over 60 countries, including the US, with more than 72
million doses distributed worldwide since
2010. Menveo offers
extensive evidence of immunogenicity with a well-characterised
safety profile.
In the US, Menveo has received regulatory approval for active
immunisation to prevent IMD caused by Neisseria
meningitidis serogroups A,
C, Y, and W in individuals from 2 months through 55 years of age.
However, Menveo does not prevent N.
meningitidis serogroup B
infections.
Please see the
US Prescribing Information:
https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Menveo/pdf/MENVEO.PDF
About Invasive meningococcal disease
Invasive meningococcal disease (IMD), a major cause of meningitis
and septicaemia, is
an uncommon but serious illness that can cause life-threatening
complications or even death.[6] Among
those contracting meningococcal diseases, one in ten will die,
sometimes in as little as 24 hours, despite
treatment.[7] One-in-five
survivors suffer long-term consequences, such as brain damage,
amputations, hearing loss and nervous system
problems.6
About GSK
GSK is a global biopharma company with a purpose to unite science,
technology, and talent to get ahead of disease together. Find out
more at: https://www.gsk.com/en-gb/company/
GSK enquiries
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Media:
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Tim
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+44 (0)
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Simon
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Kathleen
Quinn
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+1 202
603 5003
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(Washington
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Alison
Hunt
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+1 540
742 3391
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(Washington
DC)
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Investor
Relations:
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Nick
Stone
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+44 (0)
7717 618834
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(London)
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James
Dodwell
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+44 (0)
20 8047 2406
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(London)
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Mick
Readey
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+44 (0)
7990 339653
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Josh
Williams
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+44 (0)
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(London)
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Camilla
Campbell
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+44
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050238
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(London)
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Steph
Mountifield
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+44 (0)
7796 707505
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(London)
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Jeff
McLaughlin
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+1 215
751 7002
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(Philadelphia)
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Frannie
DeFranco
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+1 215
751 4855
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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 under Item 3.D
'Risk factors" in the company's Annual Report on Form 20-F for
2022, and Q1 Results for 2023 and any impacts of the COVID-19
pandemic.
Registered in England &
Wales:
No. 3888792
Registered Office:
980
Great West Road
Brentford,
Middlesex
TW8
9GS
References
1. Muzzi
A, Bodini M, Topaz N, et al. Genetic Features of a Representative
Panel of 110 Meningococcal B Isolates to Assess the Efficacy of
Meningococcal B Vaccines. mSphere. 2022;7(5): e0038522.
doi:10.1128/msphere. 00385-22.
[2]. CDC. Meningococcal Disease and
How It Spreads. Available at: https://www.cdc.gov/meningococcal/about/causes-transmission.html.
Accessed May 2023.
[3]. CDC. University-Based Outbreaks of
Meningococcal Disease Caused by Serogroup B, United States,
2013-2018
Available at: https://wwwnc.cdc.gov/eid/article/25/3/18-1574_article#r1.
Accessed May 2023.
[4]. MacNeil
JR, Blain AE, Wang
X, Cohn AC. Current epidemiology and trends in
meningococcal disease-United States, 1996-2015. Clin Infect
Dis. 2018; 66:1276-81.
[5]. Pingali C, Yankey D, Elam-Evans
LD, et al. National Vaccination Coverage Among Adolescents Aged
13-17 Years - National Immunization Survey-Teen, United States,
2021. MMWR Morb Mortal Wkly Rep 2022;
71:1101-1108.
[6].
ECDC, Facsheet about meningococcal disease. Available
at: https://www.ecdc.europa.eu/en/meningococcal-disease/factsheet.eu..
Accessed May 2023.
[7].
Bing Wang et al., "Case fatality rates of invasive meningococcal
disease by serogroup and age: A systematic review and
meta-analysis", in Vaccine, Volume 37, Issue 21, 9 May 2019, Pages
2768-2782. Accessed May 2023.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorised.
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GSK plc
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(Registrant)
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Date: May
12, 2023
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By:/s/ VICTORIA
WHYTE
--------------------------
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Victoria Whyte
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Authorised
Signatory for and on
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behalf
of GSK plc
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