REG - GSK PLC - GSK completes acquisition of IDRx, Inc.

GSKAnnouncement

24/02/2025 07:15

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RNS Number : 1768Y  GSK PLC  24 February 2025

Issued: 24 February 2025, London UK

 

GSK completes acquisition of IDRx, Inc.

 

 

GSK plc (LSE/NYSE: GSK) today announced that it has completed the acquisition
of IDRx, Inc. (IDRx), a Boston-based, clinical-stage biopharmaceutical company
dedicated to developing precision therapeutics for the treatment of
gastrointestinal stromal tumours (GIST).

 

As announced previously(1), the acquisition includes lead molecule IDRX-42, an
investigational, highly selective tyrosine kinase inhibitor (TKI) that is
designed to improve outcomes for patients with GIST. IDRX-42 has demonstrated
activity against all clinically relevant primary and secondary KIT mutations,
a key medical need in current GIST treatment. GIST typically presents in the
gastrointestinal (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).(2) 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.(3)

 

Hesham Abdullah, Senior Vice President, Global Head Oncology R&D, GSK,
said: "This acquisition adds to GSK's growing pipeline of targeted
therapeutics for cancers originating in the gastrointestinal tract. We plan to
advance IDRX-42 for second line treatment of gastrointestinal stromal tumours,
where there are no approved treatments to effectively address all resistance
mutations, and accelerate development in an earlier setting."

 

Financial Considerations

The total cash consideration for this acquisition amounts to up to $1.15
billion. This includes an upfront payment of $1 billion, with the possibility
of an additional $150 million milestone payment contingent upon success-based
regulatory approval. GSK will also be responsible for success-based milestone
payments as well as tiered royalties for IDRX-42 owed to Merck KGaA,
Darmstadt, Germany.

 

About GIST

GIST represent the most prevalent form of soft tissue sarcoma, with an
estimated annual global diagnosis of 80,000 to 120,000 patients.(4) GIST
commonly manifests in the GI tract, with approximately 80% of cases being
attributed to mutations in the KIT gene.(5) These mutations, known as primary
or activating mutations in exons 9 and 11, drive the growth, proliferation,
and survival of tumour cells. In the first line of treatment, around 90% of
patients develop secondary or resistance mutations in exons 13 and 17 of the
KIT gene, leading to relapse with limited therapeutic alternatives.(6)
Notably, there are currently no approved TKIs capable of effectively targeting
the full range of clinically significant primary and secondary mutations in
KIT.

 

About IDRX-42

IDRX-42 is a highly selective, investigational small molecule 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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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 Q4 Results for 2024.

 

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References

1 GSK enters agreement to acquire IDRx, Inc. -
https://www.gsk.com/en-gb/media/press-releases/gsk-enters-agreement-to-acquire-idrx-inc/

2 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.

3 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

4 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.

5 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.

6 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

 

 

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