China-based firms Lepu Biopharma Co., Ltd (HKG: 2157) and Keymed Biosciences Inc. (HKG: 2162) have jointly announced a licensing agreement with UK major AstraZeneca (AZ, NASDAQ: AZN) for CMG901, a potential first-in-class antibody-drug conjugate (ADC) targeting Claudin 18.2. AstraZeneca is taking on global development, manufacturing, and commercialization rights to the product candidate, with an upfront payment of USD 63 million. The UK giant also commits to at least USD 1.1 billion in development and sales-based milestones, alongside double-digit tiered royalties on any future sales.
Deal Details and Closing
The deal, contingent on customary closing conditions and regulatory approval, is expected to close during the first half of 2023. This strategic partnership aims to accelerate the development and commercialization of CMG901, leveraging AstraZeneca’s global capabilities and resources.
CMG901: First-in-Class CLDN18.2-Targeted ADC
CMG901 is the world’s first CLDN18.2-targeted ADC to enter clinical trials in both China and the United States. The drug candidate is owned by KYM Bio, a joint venture between Lepu and Keymed (with a 30%/70% ownership respectively) established for the molecule’s development. CMG901 consists of an anti-CLDN18.2 monoclonal antibody, a protease-degradable linker, and the cytotoxic small molecule monomethyl auristatin E (MMAE).
Clinical Trial Results and Development Targets
Preliminary results from an ongoing Phase I study for CMG901 in CLDN18.2-positive solid tumors have shown that the drug has a good safety and tolerability profile, alongside encouraging anti-tumor efficacy at the current dosage level. Gastrointestinal cancers are expected to be among the leading development targets for the drug, highlighting its potential to address significant unmet medical needs in this area.
Strategic Implications
The licensing agreement with AstraZeneca represents a significant milestone for Lepu Biopharma and Keymed Biosciences. By partnering with a global leader like AstraZeneca, the companies aim to accelerate the development of CMG901 and bring this innovative treatment to patients worldwide. This move is expected to enhance the companies’ global presence and contribute to the advancement of cancer therapies.
