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 January 2025
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: 13 January 2025, London UK
GSK enters agreement to acquire IDRx, Inc.
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Acquisition
includes IDRX-42, a highly selective KIT tyrosine kinase inhibitor
(TKI) designed to treat
gastrointestinal stromal tumours (GIST)
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IDRX-42
offers potential to address all key KIT mutations in GIST that
drive tumour growth and progression and improve tolerability, gaps
in current therapies
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Acquisition
adds to GSK's growing portfolio in gastrointestinal (GI)
cancers
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GSK
to pay up to $1.15 billion
GSK plc (LSE/NYSE: GSK) and IDRx, Inc. (IDRx) today announced that
they have entered into an agreement under which GSK will acquire
IDRx, a Boston-based, clinical-stage biopharmaceutical company
dedicated to developing precision therapeutics for the treatment of
GIST. Under the agreement, GSK will pay $1 billion upfront, with
potential for an additional $150 million success-based regulatory
approval milestone payment. The acquisition includes lead molecule,
IDRX-42, a highly selective KIT TKI being developed as a first- and
second-line therapy for the treatment of GIST.
GIST typically presents in the GI tract with 80% of cases driven by
mutations in the KIT gene that lead to the growth, proliferation,
and survival of tumour cells (primary or activating
mutations).1 90%
of patients treated in the first-line develop new KIT mutations
(secondary or resistance mutations) that typically lead to relapse
with limited therapeutic options.2 Currently,
there are no approved TKIs that inhibit the full spectrum of
clinically relevant primary and secondary mutations in
KIT.
IDRX-42 has demonstrated activity against all key primary and
secondary KIT mutations, designed to improve outcomes for patients
with GIST. This breadth of mutational coverage, in addition to high
selectivity which could improve tolerability, provides potential
for a best-in-class profile.
Luke Miels, Chief Commercial Officer, GSK, said: "IDRX-42
complements our growing portfolio in gastrointestinal cancers. This
acquisition is consistent with our approach of acquiring assets
that address validated targets and where there is clear unmet
medical need, despite existing approved
products."
Tony Wood, Chief Scientific Officer, GSK, said: "We
are excited by the early data from IDRX-42 and its unique ability
to target all clinically relevant KIT mutations present in GIST, a
major gap in the current standard of care. We look forward to
accelerating its development in 2025 to redefine
treatment."
Updated clinical data from StrateGIST 1, an ongoing phase I/Ib
trial of IDRX-42 in patients with advanced GIST, were presented in
an oral presentation at the Connective Tissue Oncology Society
(CTOS) 2024 Annual Meeting. These data show promising anti-tumour
activity of IDRX-42 in patients with advanced GIST with a
manageable safety profile. Across patients with second-line or
greater GIST, and amongst all KIT mutation subsets, the objective
response rate (ORR) by modified RECIST v1.1 in the total efficacy
evaluable population was 29% (n=87), including one complete
response (CR) and 24 partial responses (PRs). Amongst patients who
have had one prior line of therapy, the ORR was 53% (n=15)
including one CR and 7 PRs.3
Across all patients, two of the PRs were awaiting confirmation at
the time of the data cut, both of which were subsequently
confirmed. The emerging durability data from StrateGIST 1 was also
favourable. IDRX-42 was generally well-tolerated and
treatment-related adverse events (TRAEs) were mainly low grade at
the recommended phase Ib dose.4
Tim Clackson, CEO, IDRx, said: "We
are looking forward to working with GSK to advance IDRX-42 for
patients with GIST given there have been no major advances to the
standard of care for almost 20 years. Combining our experience to
date with GSK's expertise in GI cancers, global clinical
development capability, and strong commercial presence in oncology
will help to accelerate the development of this novel medicine for
patients."
GSK has a growing portfolio in development targeting the
significant medical need in GI cancers, including ongoing trials
with dostarlimab and GSK5764227 (GSK'227), a B7-H3-targeted
antibody-drug conjugate. This agreement reflects GSK's portfolio
approach of identifying potentially best-in-class molecules with
targeted mechanisms of action. The transaction supports GSK's
ambitions for growth through 2031 and beyond.
Financial considerations
Under the terms of the agreement, GSK will acquire one hundred
percent (100%) of the outstanding equity interests (including all
options and other incentive equity) in IDRx for up to $1.15 billion
of total cash consideration, comprising an upfront payment of $1
billion with potential for an additional $150 million success-based
regulatory approval milestone payment. GSK will also be responsible
for success-based milestone payments as well as tiered royalties
for IDRX-42 owed to Merck KGaA, Darmstadt, Germany.
This transaction is subject to customary conditions, including
applicable regulatory agency clearances under the Hart-Scott-Rodino
Act in the US.
For IDRx, Centerview Partners LLC is acting as exclusive financial
advisor and Goodwin Procter LLP as legal counsel. For GSK, Leerink
Partners LLC is acting as the exclusive financial
advisor.
About GIST
Gastrointestinal stromal tumours (GIST) are the most common subtype
of soft tissue sarcoma, with about 80,000 to
120,000 patients diagnosed
with GIST per year worldwide.5 GIST
typically presents in the GI tract with 80% of cases driven by
mutations in the KIT gene that lead to the growth, proliferation,
and survival of tumour cells (primary or activating mutations in
exons 9 and 11).6 Additionally,
about 90% of patients treated in the first-line develop new KIT
mutations (secondary or resistance mutations in exons 13 and 17)
that typically lead to relapse with limited therapeutic
options.7 There
are no approved TKIs that inhibit the full spectrum of clinically
relevant primary and secondary mutations in
KIT.
About IDRX-42
IDRX-42 is a highly selective, investigational small molecule
tyrosine kinase inhibitor (TKI) designed to target all key KIT
mutations in GIST. The U.S. Food and Drug Administration (FDA) has
granted IDRX-42 Fast Track designation for the treatment of
patients with GIST after disease progression on or intolerance to
imatinib, and Orphan Drug designations for the treatment of
GIST.
About IDRx
IDRx is a clinical-stage biopharmaceutical company dedicated to
transforming cancer care with intelligently designed precision
therapies. IDRx aims to address the limitations of today's
precision cancer medicines with highly potent and selective
targeted therapies to stop key tumour escape mechanisms and prolong
response to therapy.
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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Tim Foley
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+44 (0) 20 8047 5502
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(London)
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Sarah Clements
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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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Lyndsay Meyer
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+1 202 302 4595
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(Washington DC)
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Investor Relations:
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Annabel Brownrigg-Gleeson
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+44 (0) 7901 101944
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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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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 Q3 Results for 2024.
Registered in England & Wales:
No.
3888792
Registered Office:
79
New Oxford Street
London
WC1A
1DG
References
1 Bauer
S, George S, von Mehren M, Heinrich MC. Early
and Next-Generation KIT/PDGFRA Kinase Inhibitors and the Future of
Treatment for Advanced Gastrointestinal Stromal Tumor. Front Oncol.
2021 Jul 12;11:672500.
2 Zhou
S, Abdihamid O, Tan F, Zhou H, Liu H, Li Z, Xiao S, Li B. KIT
mutations and expression: current knowledge and new insights for
overcoming IM resistance in GIST. Cell
Commun Signal. 2024 Feb 27;22(1):153.
3 George
et al CTOS 2024
4 George
et al CTOS 2024
5 Søreide K, Sandvik OM, Søreide JA, Giljaca V, Jureckova
A, Bulusu VR. Global epidemiology of gastrointestinal stromal
tumours (GIST): A systematic review of population-based cohort
studies. Cancer Epidemiol. 2016 Feb;40:39-46.
6 Bauer
S, George S, von Mehren M, Heinrich MC. Early
and Next-Generation KIT/PDGFRA Kinase Inhibitors and the Future of
Treatment for Advanced Gastrointestinal Stromal Tumor. Front Oncol.
2021 Jul 12;11:672500.
7 Zhou
S, Abdihamid O, Tan F, Zhou H, Liu H, Li Z, Xiao S, Li B. KIT
mutations and expression: current knowledge and new insights for
overcoming IM resistance in GIST. Cell
Commun Signal. 2024 Feb 27;22(1):153.
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: January
13, 2025
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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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