CHENGDU, China, February 23, 2023 – Keymed Biosciences Inc., (“Keymed”) (Stock Code: 02162 HK)and LepuBiopharma Co., Ltd, (Stock Code: 02157.HK) today jointly announce a global exclusive licence agreement with AstraZeneca (LSE/STO/Nasdaq: AZN) for CMG901, a potential first-in-class Claudin 18.2 antibody drug conjugate (ADC). Under the licence agreement, AstraZeneca will be responsible for the research, development, manufacture and commercialisation of CMG901 globally.
CMG901 is currently in a Phase I clinical trial for the treatment of Claudin 18.2-positive solid tumors. Preliminary results from the Phase 1 trial indicated that CMG901 has a favorable safety and tolerability profile, and encouraging anti-tumor efficacy across the dose levels tested.
Under the terms of the agreement, KYM Biosciences, the joint venture established by Keymed and Lepu Biopharma, will receive an upfront payment of $63m on transaction closing and additional development and sales-related milestone payments of up to $1.1bn 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.
Dr. Bo Chen, Chief Executive Officer of Keymed and Board Chairman of KYM said, “We are pleased to have partnered 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.”
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.”
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 has entered into a definitive agreement for an exclusive global license to CMG901 from KYM, reflecting AstraZeneca’s strategy to invest in antibody drug conjugates and expand its portfolio in gastrointestinal (GI) cancers.