FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of September 2026
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
AstraZeneca announces equity investment in Summit
29 September
2026
AstraZeneca announces strategic equity investment and
clinical
collaboration with Summit Therapeutics to advance
leading ADC combination strategy in cancer
Clinical collaboration will evaluate sonesitatug vedotin, a
Claudin-18.2 ADC, with ivonescimab, a first-in-class PD-1/VEGF
bispecific, in gastrointestinal cancers
Planned broader clinical collaboration will combine Company's
leading
portfolio of cancer medicines including ADCs with
ivonescimab
AstraZeneca has entered into an agreement to invest $2 billion in
newly issued equity in Summit Therapeutics Inc. to accelerate the
development of ivonescimab, a first-in-class bispecific antibody
targeting PD-1 and VEGF, in combination with antibody drug
conjugates (ADCs) across tumour types.
Summit and AstraZeneca have also entered into a clinical
collaboration agreement to evaluate sonesitatug vedotin
(Sone-Ve) in combination with ivonescimab. Sone-Ve is a
potential global first-in-class CLDN18.2-targeting ADC with a
monomethyl auristatin E (MMAE) payload with several ongoing trials
underway in gastrointestinal (GI) cancers. The companies intend to
initiate trials in GI cancers under the collaboration
imminently.
Under the terms of this agreement, each company will contribute
their respective medicine for the planned combination trials and
jointly contribute to trial costs. Each company will retain
development and commercial rights to their respective
medicines.
The two companies have also executed a Memorandum of Understanding
(MOU) with the intent to enter into an agreement initiating a
global development programme combining ivonescimab with
AstraZeneca’s cancer medicines, including additional
ADCs.
Susan Galbraith, Executive Vice President, Oncology Haematology
R&D, AstraZeneca, said: “A core pillar of our oncology
strategy is to broaden the reach of our ADC portfolio as the
backbone of treatment across tumour types with combinations
alongside next-generation immunotherapies. Bispecifics targeting
PD-1 and VEGF are rapidly advancing in development and have the
potential to improve on current immunotherapies, particularly in
lung, breast and gastrointestinal cancers. This opportunity to
combine ivonescimab with AstraZeneca’s ADC portfolio,
including with Sone-Ve, could enable new regimens that raise the
bar for patients with cancer across the treatment
landscape."
Dr. Maky Zanganeh, President and Co-Chief Executive Officer of
Summit Therapeutics, said: “The developments announced today
with AstraZeneca open an exciting new chapter in the advancement of
ivonescimab. With a growing body of evidence supporting
ivonescimab’s differentiated PD-1 / VEGF bispecific approach,
we look forward to further broadening the development plan of
ivonescimab and initiating new clinical trials exploring the
potential to combine ivonescimab with promising novel anti-cancer
compounds, including ADCs, to bring together complementary
approaches to tumour-cell killing, antitumour immunity, and the
tumour microenvironment.”
AstraZeneca recently reported positive high-level results from the
CLARITY-Gastric01 trial for Sone-Ve in 2nd and later-line
Claudin18.2-positive advanced gastric cancers demonstrating a
statistically significant and highly clinically meaningful
improvement in overall survival (OS) versus investigator’s
choice of therapy. Results from this trial will be presented at the
European Society for Medical Oncology Congress 2026 in a
Presidential Symposium.
Ivonescimab is a novel, potential first-in-class bispecific
antibody combining the effects of immunotherapy via a blockade of
PD-1 with the anti-angiogenesis effects associated with blocking
VEGF into a single molecule. Ivonescimab was engineered by
Akeso Inc. Summit has exclusive rights to develop and commercialise
ivonescimab in major territories outside China, while its partner
Akeso Inc. retains rights in China and other regions.
Ivonescimab is approved to treat certain patients with non-small
cell lung cancer (NSCLC) in China, and a Biologics License
Application (BLA) seeking approval in EGFR-mutated NSCLC is under
review by the US Food and Drug Administration (FDA). Ivonescimab is
currently being studied in Phase III clinical trials in NSCLC,
small cell lung cancer, BTC, bladder cancer, triple-negative breast
cancer, head and neck squamous cell carcinoma, colorectal cancer,
and pancreatic cancer.
Financial considerations
Summit Therapeutics will receive an equity investment of $2 billion
from AstraZeneca. AstraZeneca will purchase an aggregate of
approximately 109 thousand shares of preferred stock convertible
into shares of common stock of Summit at a 1:1,000 ratio. Following
completion of the investment, AstraZeneca will hold rights
equivalent to approximately 12.0% of Summit Therapeutics
outstanding common stock (approximately 10.6% on a fully diluted
basis).
Closing of the investment in preferred stock is anticipated within
one week. Conversion of AstraZeneca’s preferred stock to
common stock in the future would be subject to customary regulatory
clearances.
Notes
Sonesitatug vedotin (Sone-Ve)
Sone-Ve is a novel ADC targeting CLDN18.2, a protein found in the
stomach lining and a validated therapeutic target in oncology,
particularly for GI cancers. Sone-Ve consists of an anti-CLDN18.2
monoclonal antibody, a protease-degradable linker and a cytotoxic
small molecule MMAE payload.
AstraZeneca entered into a global exclusive licence agreement with
KYM Biosciences to develop and commercialise Sone-Ve in
March
2023.
In addition to CLARITY-Gastric01, Sone-Ve is being evaluated in the
CLARITY-Gastric02 Phase III trial in combination with capecitabine,
with or without rilvegostomig, as a 1st-line treatment for advanced
or metastatic gastric cancer, GEJ cancer and EAC. In Phase II
development, Sone-Ve is being evaluated in patients with advanced
solid tumours in multiple combinations across settings, including
in CLDN18.2-positive pancreatic and BTC.
AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition
to provide cures for cancer in every form, following the science
to understand cancer and all its complexities to
discover, develop and deliver life-changing medicines to
patients.
The Company's focus is on some of the most challenging cancers. It
is through persistent innovation that AstraZeneca has built one of
the most diverse portfolios and pipelines in the industry, with the
potential to catalyse changes in the practice of medicine and
transform the patient experience.
AstraZeneca has the vision to redefine cancer care and, one
day, eliminate cancer as a cause of
death.
AstraZeneca
AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led
biopharmaceutical company that focuses on the discovery,
development, and commercialisation of prescription medicines in
Oncology, Rare Disease, and BioPharmaceuticals, including
Cardiovascular, Renal & Metabolism, and Respiratory &
Immunology. Based in Cambridge, UK, AstraZeneca’s innovative
medicines are sold in more than 125 countries and used by millions
of patients worldwide. Please visit astrazeneca.com
and follow the Company on Social
Media @AstraZeneca.
Contacts
For details on how to contact the Investor Relations Team, please
click here.
For Media contacts, click here.
Matthew Bowden
Company Secretary
AstraZeneca PLC
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 authorized.
Date: 29 September 2026
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By: /s/
Matthew Bowden
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Name:
Matthew Bowden
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Title:
Company Secretary
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