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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 September 2024
Commission
File Number 001-15170
GSK plc
(Translation
of registrant's name into English)
79 New Oxford Street, London, WC1A 1DG
(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 September 2024, London UK
GSK announces positive headline data from phase II seasonal
influenza mRNA vaccine programme
●
A
vaccine candidate formulation demonstrated positive A and B strain
immune responses relative to standard of care in both younger and
older adults
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mRNA
platform elicits strong overall antibody titres with an acceptable
safety profile
●
Data
support progression to phase III clinical trials
GSK plc (LSE/NYSE: GSK) today announced positive headline results
of a phase II trial (NCT06431607) for its mRNA seasonal influenza
vaccine programme. The trial studied a range of mRNA formulations
in older and younger adults to evaluate vaccine candidates that
could improve immune responses against influenza A and B strains,
compared to the current standard of care.
In both younger and older adults, pre-defined success criteria were
met. Interim data suggest the vaccine candidates have an acceptable
safety and reactogenicity profile for all mRNA formulations
tested.
These results build on the previous phase II trial and confirm the
mRNA platform elicits strong overall antibody titres with an
acceptable safety profile. With these results, the GSK mRNA
seasonal influenza vaccine programme will progress into late-stage
clinical development.
GSK's Chief Scientific Officer, Tony Wood said: "This
marks a significant advancement in our mRNA programme and these
data support moving into late-stage development. Ultimately, our
goal is to develop a new best-in-class vaccine to bring greater
protection to people through the influenza
season."
GSK recently signed a new licensing agreement with CureVac to
assume full control of developing and manufacturing influenza and
COVID-19 candidate vaccines. GSK continues to develop and optimise
its mRNA capabilities through investments and partnerships,
including in AI/ML-based sequence optimisation, nanoparticle design
and manufacturing.
About study NCT06431607 https://www.clinicaltrials.gov/study/NCT06431607
The phase II study assesses the
reactogenicity, safety, and immunogenicity of different dose levels
of a modified, multivalent vaccine candidate, encoding antigens
matched to all three WHO-recommended influenza strains. The study
includes 250 healthy younger adults aged 18 to 64 and 250 healthy
older adults aged 65 to 85. In each age group, different dose
levels were tested
in comparison to an age-appropriate, licensed comparator
vaccine.
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 gsk.com.
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GSK enquiries
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Media:
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Simon Moore
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+44 (0) 20 8047 5502
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(London)
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Kathleen Quinn
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+1 202 603 5003
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(Washington DC)
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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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(London)
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Josh Williams
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+44 (0) 7385 415719
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(London)
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Camilla Campbell
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+44 (0) 7803 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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(Philadelphia)
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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 GSK's Annual Report on Form 20-F for 2023, and
GSK's Q2 Results for 2024.
Registered in England & Wales:
No.
3888792
Registered Office:
79
New Oxford Street
London
WC1A
1DG
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: September
12, 2024
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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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