AstraZeneca has signed an exclusive global license agreement with KYM Biosciences, a joint venture of Keymed Biosciences and Lepu Biopharma, for CMG901.

CMG901 is a potential first-in-class antibody drug conjugate (ADC) 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).

The investigational agent is being developed for the treatment of solid tumors that express the cell surface protein Claudin 18.2, including gastric cancers.

Under the license agreement, AstraZeneca will be responsible for the research, development, manufacture and commercialization of CMG901 globally.

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CMG901 is currently being evaluated in a Phase I clinical trial for the treatment of Claudin 18.2-positive solid tumors, including gastric cancer. Preliminary results from the Phase 1 trial have shown an encouraging clinical profile for CMG901, with early signs of anti-tumor activity across the dose levels tested.

Agreement
AstraZeneca will make an upfront payment of US $ 63 million on transaction closing and additional development and sales-related milestone payments of up to US $ 1.1 billion 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.

AstraZeneca has a broad development program for the treatment of gastrointestinal (GI) cancers across several medicines and a variety of tumor 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]

Ongoing development
“We are excited by the opportunity to accelerate the development of CMG901, a potential new medicine for patients with Claudin 18.2-expressing cancers,” noted Puja Sapra, Senior Vice President, Biologics Engineering & Oncology Targeted Delivery, Oncology R&D, AstraZeneca.

“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,” Sapra added.

“We are pleased to announce our agreement with AstraZeneca, a global biopharmaceutical company with leadership in developing and commercializing novel anti-cancer therapies,” said Bo Chen, Ph.D., Chief Executive Officer of Keymed and Board Chairman of KYM Biosciences.

“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,” Chen further noted.

Note: * CMG901 is owned by KYM Biosciences (KYM), a joint venture established by affiliates of Keymed Biosciences (70% of KYM ownership) and Lepu Biopharma (30% of KYM ownership).

Reference 
[1] World Health Organization. World Cancer Fact Sheet. Online. Last accessed on February 23, 2023.

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