China’s First Personalized Neoantigen-Targeted Cancer Vaccine Receives NMPA’s Clinical Trial Approval

According to the latest data released in the Clinical Trials Implied Approval section on the website of China’s Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), Likang Life Sciences has received implied approval for the clinical trial of its personalized neoantigen-targeted vaccine for advanced solid cancer tumors, LK101 Injection. This is the first personalized neoantigen vaccine & mRNA editing product approved by the NMPA to enter clinical stage.

On December 22, 2022, Likang submitted an IND application for LK101 Injection to NMPA, and received an application shortly after. LK101 Injection, the first in-house developed cancer vaccine candidates by Likang, is a personalized neoantigen-targeted cancer vaccine and also a dendritic cell (DC)-based mRNA vaccine that combines the advantages of both mRNA technology and DC by transducing mRNA encoding personalized tumor antigen targets based on dozens of patient-specific tumor mutations information into dendritic cells.

The mRNA editing technology is a highly convenient method that can encode multiple antigens at once while maintaining rapid, efficient expression, making it suitable for the development of personalized cancer treatments. DCs, which are highly specialized and strong antigen-presenting cells in human immune system, have been utilized in the development of tumor vaccines. DC vaccines have demonstrated high safety and good tolerance, effectively activating tumor-specific T cells and establishing immunological memory, resulting in long-term anti-cancer effects. The combination of mRNA vaccine and DC vaccine provides a potential breakthrough in the field of personalized neoantigen treatment, offering an effective and safe approach for patients to fight against cancer.

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 data showed that LK101 have good safety and tolerance, no grade I or higher drug-related adverse reactions reported. Activation of anti-tumor neoantigen immune response detected in all patients, showing significant advantages in terms of postoperative recurrence rate and survival rate.