Likang Life Sciences has announced that it has received Investigational New Drug (IND) approval from the National Medical Products Administration (NMPA) for its LK101, a personalized neoantigen-targeted vaccine. This marks the first personalized neoantigen vaccine and mRNA editing product to be approved for clinical trials by the NMPA. LK101 will initially be assessed against a range of advanced solid tumor types.
Development and Mechanism of LK101
Developed in-house by Likang, LK101 combines a personalized neoantigen-targeted cancer vaccine with a dendritic cell (DC)-based mRNA vaccine. This innovative approach allows for the transduction of mRNA encoding personalized tumor antigen targets based on dozens of patient-specific tumor mutations into dendritic cells. This method aims to enhance the immune system’s ability to recognize and attack cancer cells.
Previous Clinical Trial and Results
LK101 has previously been tested in Chinese hospitals. In 2018, Likang collaborated with the Chinese PLA General Hospital to conduct an investigator-initiated clinical trial (IIT) of LK101 injection for postoperative liver cancer patients. The study demonstrated that LK101 has a good safety profile, with no grade 1 or higher drug-related adverse reactions reported. Additionally, an anti-tumor neoantigen immune response was activated in all patients, leading to improvements in postoperative recurrence rate and survival rate.-Fineline Info & Tech
