GSK宣布mRNA季节性流感疫苗候选物Phase II数据积极，将于2026年9月启动III期临床试验

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6-K
1
a7703s.htm
MRNA FLU VACCINE CANDIDATE TO ADVANCE TO PHASE III
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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 2026
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: September 1 2026, London UK
GSK to advance mRNA seasonal flu vaccine candidate to phase III
following positive phase II data
●
Results showed higher immune
responses versus standard and high dose flu
vaccines
in
younger and older adults respectively
[1]
●
Vaccine candidate designed
to
target
the two primary surface antigens that cause flu viruses to bind and
spread
●
Phase
III trial to start in September 2026
GSK plc (LSE/NYSE: GSK)
presented
positive phase II data for its mRNA seasonal influenza (flu)
vaccine candidate at the
OPTIONS
XIII Conference for the Control of Influenza.
GSK's
vaccine candidate
showed
higher immune responses against all influenza strains
tested
compared
to
licensed standard dose and high dose inactivated flu vaccines in
younger and older adults respectively, and was generally well
tolerated.
1
Based
on these results,
GSK
intends to start a phase III efficacy trial in September
2026.
This will be the first phase III trial of an mRNA flu vaccine
designed to target both
haemagglutinin
(HA) and neuraminidase (NA), the primary surface antigens that
cause the flu virus to bind and spread.
[2]
While
licensed flu vaccines primarily target HA, GSK's vaccine candidate
is specifically designed to also target NA. Growing evidence
suggests this could help improve protection, illness severity and
transmission.
1,
[3]
Sanjay Gurunathan, GSK Head of Vaccines and Infectious Diseases
Research and Development (R&D)
, said: "These promising data support the
potential to better protect people from flu with a vaccine designed
to target both HA and NA. With one billion flu cases worldwide each
year and up to 650,000 deaths there is a need for next generation
vaccine approaches.
[4]
This
result is a significant advance in our cutting-edge mRNA programme,
and we look forward to starting phase III
imminently."
In July 2026, the US Food and Drug Administration (FDA) granted the
vaccine candidate Fast Track designation for the targeted age
indication, reflecting the urgent need to improve flu
protection.
4
About the Flu-028 phase II trial
Flu-028 is a randomised, observer-blind phase II trial assessing
the immunogenicity and safety of mRNA-based multivalent seasonal
flu vaccine candidates in 971 adults 18 years of age and
older.
Adults
18-64 and ≥65 years of age received different dose levels of
either FLUm3HA.b-3NA (encoding an optimised B-strain HA),
FLUm3HA-3NA (encoding non-optimised B/HA) or licensed
age-appropriate comparators. Immunogenicity and
reactogenicity/safety data up to day 181 post-vaccination were
assessed.
1
Previous studies highlighted the gaps in flu vaccination, including
the role of NA and the need to improve B-strain HA
immunogenicity.
[5]
,
[6]
In
the Flu-028 phase II trial, GSK's FLUm3HA.b-3NA flu vaccines
demonstrated robust immune responses to HA and NA from influenza A
and B strains in younger and older adults.
1
Reactogenicity
and safety profiles of the vaccines were
acceptable.
1
Based
on the results, GSK will further investigate the optimised B-strain
HA (FLUm3HA.b-3NA) candidate in a phase III efficacy
trial.
About GSK's mRNA seasonal flu vaccine candidate
GSK's investigational mRNA seasonal flu vaccine programme is
designed to target haemagglutinin (HA) and neuraminidase
(NA).
1
It
is part of GSK's respiratory vaccines research and ongoing work to
explore new approaches to seasonal flu
prevention.
GSK's
investigational mRNA seasonal flu vaccine candidate is not approved
anywhere in the world.
About seasonal flu
Seasonal flu is a contagious respiratory infection that remains a
significant global public health challenge, causing substantial
illness every year and placing considerable pressure on healthcare
systems.
4
Seasonal
influenza causes around one billion cases globally each year,
including up to 5 million cases of severe
illness
and
up to 650,000 respiratory deaths.
4
Those
at increased risk include older adults, pregnant women and people
with underlying health conditions. Although vaccination remains the
cornerstone of flu prevention, a significant burden of disease
still exists, reinforcing the need for continued research into
approaches that may improve protection.
4
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
www.gsk.com
.
GSK enquiries
Media:
Tim
Foley
+44 (0)
20 8047 5502
(London)
Simon
Moore
+44 (0)
20 8047 5502
(London)
Kathleen
Quinn
+1 202
603 5003
(Washington
DC)
Alison
Hunt
+1 540 742 3391
(Washington
DC)
Investor
Relations:
Constantin
Fest
+44 (0)
7831 826525
(London)
Joanna
Tuplin
+44 (0)
7788 351650
(London)
James
Dodwell
+44 (0)
7881 269066
(London)
Mick
Readey
+44 (0)
7990 339653
(London)
Sam
Piper
+44 (0)
7824 525779
(London)
Dan
Smith
+44 (0)
7823 523885
(London)
Jeff
McLaughlin
+1 215
751 7002
(Philadelphia)
Frannie
DeFranco
+1 215
751 3126
(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 "Risk
Factors" section in GSK's Annual Report on Form 20-F for 2025, and
GSK's Q2 Results for 2026.
Registered in England & Wales:
No.
3888792
Registered Office:
79
New Oxford Street
London
WC1A
1DG
References
[1]
Oh
K-B, et al. A Phase 2 Trial Assessing Immunogenicity and Safety of
an mRNA-Based Seasonal Influenza Vaccine Candidate Encoding
Hemagglutinin and Neuraminidase. Presented at the Options XIII
Conference for the Control of Influenza; August 31, 2026;
Washington, DC, USA. Oral presentation OA10.06 (Abstract
#522).
[2]
Gamblin
SJ, Skehel JJ. Influenza Hemagglutinin and Neuraminidase Membrane
Glycoproteins.
J
Biol Chem. 2010;285(37):28403-28409.
doi:10.1074/jbc.R110.129809.
[3]
Evans
K, et al.
Advancing
Protection against Influenza Through Neuraminidase-Targeted
Immunity. Presented at the Options XIII Conference for the Control
of Influenza; September 1, 2026; Washington, DC, USA. Oral
presentation OA14.01 (Abstract #205).
[4]
World
Health Organization. Influenza (seasonal). Available at:
https://www.who.int/news-room/fact-sheets/detail/influenza-(seasonal).
Last accessed: August 2026.
[5]
Miller
MS, et al. Seasonal influenza vaccines: Variability of immune
responses to B lineage viruses. Hum Vaccin Immunother.
2024;20(1):2421096.
doi:10.1080/21645515.2024.2421096.
[6]
Krammer
F, et al.
NAction!
How Can Neuraminidase-Based Immunity Contribute to Better Influenza
Virus Vaccines? mBio. 2018;9(2):e02332-17.
doi:10.1128/mBio.02332-17.
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.
GSK plc
(Registrant)
Date:
September 01, 2026
By:/s/ VICTORIA
WHYTE
--------------------------
Victoria Whyte
Authorised
Signatory for and on
behalf
of GSK plc