TIDMAZN
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 and follow the
Company on Twitter @ AstraZeneca .
Contacts
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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
. Accessed February 2023.
Adrian Kemp
Company Secretary
AstraZeneca PLC
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