REG - AstraZeneca PLC - AstraZeneca enters agreement with KYM for CMG901

AstraZenecaAnnouncement

23/02/2023 07:00

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RNS Number : 7762Q  AstraZeneca PLC  23 February 2023

23 February 2023 07:00 GMT

 

AstraZeneca enters license agreement with KYM Biosciences for CMG901, a
Claudin-18.2 antibody drug conjugate

 

CMG901 expands AstraZeneca's commitment in gastric cancer

 

AstraZeneca and KYM Biosciences Inc.(i) have entered into a global exclusive
licence agreement for CMG901, a potential first-in-class antibody drug
conjugate (ADC) targeting Claudin 18.2, a promising therapeutic target in
gastric cancer. Under the licence agreement, AstraZeneca will be responsible
for the research, development, manufacture and commercialisation of CMG901
globally.

 

CMG901 is currently being evaluated in a Phase I clinical trial for the
treatment of Claudin 18.2-positive solid tumours, including gastric cancer.
Preliminary results from the Phase I trial have shown an encouraging clinical
profile for CMG901, with early signs of anti-tumour activity across the dose
levels tested.

 

Puja Sapra, Senior Vice President, Biologics Engineering & Oncology
Targeted Delivery, Oncology R&D, AstraZeneca, said, "We are excited by the
opportunity to accelerate the development of CMG901, a potential new medicine
for patients with Claudin18.2-expressing cancers. CMG901 strengthens our
growing pipeline of antibody drug conjugates and supports our ambition to
expand treatment options and transform outcomes for patients with
gastrointestinal cancers."

 

Dr Bo Chen, Chief Executive Officer of Keymed and Board Chairman of KYM
Biosciences, said, "We are pleased to announce our agreement with AstraZeneca,
a global biopharmaceutical company with leadership in developing and
commercializing novel anti-cancer therapies. This is not only a recognition of
CMG901, a potential first-in-class Claudin 18.2 ADC, but also Keymed's
internal discovery and development capabilities. The global scope of this
agreement has the potential to benefit patients in China, and throughout the
world."

 

Financial considerations

AstraZeneca will make an upfront payment of $63m on transaction closing and
additional development and sales-related milestone payments of up to $1.1bn to
KYM Biosciences as well as tiered royalties up to low double digits.

 

The transaction is expected to close in the first half of 2023, subject to
customary closing conditions and regulatory clearances. The transaction does
not impact AstraZeneca's financial guidance for 2023.

 

i. KYM Biosciences is a joint venture established by affiliates of Keymed
Biosciences and Lepu Biopharma.

 

Notes

 

CMG901

CMG901 is a novel antibody drug conjugate targeting Claudin 18.2, and consists
of an anti-Claudin 18.2 monoclonal antibody, a protease-degradable linker, and
a cytotoxic small molecule monomethyl auristatin E (MMAE). CMG901 is being
developed for the treatment of solid tumours that express the cell surface
protein Claudin 18.2, including gastric cancers. CMG901 is owned by KYM
Biosciences Inc. (KYM), a joint venture established by affiliates of Keymed
Biosciences (70% of KYM ownership) and Lepu Biopharma (30% of KYM ownership).

 

AstraZeneca in gastrointestinal cancers

AstraZeneca has a broad development programme for the treatment of
gastrointestinal (GI) cancers across several medicines and a variety of tumour
types and stages of disease. In 2020, GI cancers collectively represented
approximately 5.1 million new cancer cases leading to approximately 3.6
million deaths.(1)

 

Within this programme, the Company is committed to improving outcomes in
gastric, liver, biliary tract, oesophageal, pancreatic and colorectal cancers.

 

Imfinzi (durvalumab) is approved in the US in combination with chemotherapy
(gemcitabine plus cisplatin) for advanced biliary tract cancer and in
combination with Imjudo in unresectable hepatocellular carcinoma. Imfinzi is
being assessed in combinations, including with Imjudo in liver,
oesophageal and gastric cancers in an extensive development programme
spanning early to late-stage disease across settings.

 

Enhertu (trastuzumab deruxtecan), a HER2-directed antibody drug conjugate, is
approved in HER2-positive advanced gastric cancer and is being assessed in
colorectal cancer. Enhertu is jointly developed and commercialised by
AstraZeneca and Daiichi Sankyo.

 

Lynparza (olaparib), a first-in-class PARP inhibitor, is approved in
BRCA-mutated metastatic pancreatic cancer. Lynparza is developed and
commercialised in collaboration with MSD (Merck & Co., Inc. inside the US
and Canada).

 

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/Nasdaq: AZN) is a global, science-led biopharmaceutical
company that focuses on the discovery, development, and commercialisation of
prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals,
including Cardiovascular, Renal & Metabolism, and Respiratory &
Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries
and its innovative medicines are used by millions of patients worldwide.
Please visit astrazeneca.com (http://www.astrazeneca.com/)  and follow the
Company on Twitter @AstraZeneca (https://twitter.com/AstraZeneca) .

Contacts

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(https://www.astrazeneca.com/investor-relations.html#Contacts) . For Media
contacts, click here (https://www.astrazeneca.com/media-centre/contacts.html)
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References

1. World Health Organization. World Cancer Fact Sheet. Available at:
https://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf
(https://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf)
. Accessed February 2023.

 

Adrian Kemp

Company Secretary

AstraZeneca PLC

 

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