China's First Personalized Neoantigen Cancer Vaccine LK101 Receives NMPA Approval for Clinical Trials

Today, the Center for Drug Evaluation (CDE) of the National Medical Products Administration updated its database on implied clinical trial approvals. LK101 Injection, a personalized tumor neoantigen vaccine product under Beijing Likang Life Technology Co., Ltd. (hereinafter referred to as “Likang”), has received implied approval for clinical trials, with advanced solid tumors as the indication.This is the first personalized tumor neoantigen vaccine in China to receive NMPA approval for entry into clinical trials, and also the first fully personalized mRNA editing product approved for clinical development.

Source: Official Website of the Center for Drug Evaluation (CDE), National Medical Products Administration of China

On December 22, 2022, Likang submitted an Investigational New Drug (IND) application for LK101 Injection to the National Medical Products Administration (NMPA), which was accepted. LK101 Injection is Likang’s first fully self-developed core pipeline asset. It is a personalized tumor neoantigen vaccine formulated as an mRNA-DC vaccine. By transfecting dendritic cells with mRNA encoding dozens of personalized tumor antigen targets designed based on patient-specific autologous tumor mutation profiles, it combines the advantages of both mRNA vaccines and dendritic cell (DC) vaccines.

mRNA technology offers a highly convenient editing approach, enabling the simultaneous encoding of multiple antigens with rapid and efficient expression, making it particularly well-suited for the development of personalized cancer therapeutics. Dendritic cells (DCs) are the most highly specialized and potent antigen-presenting cells in the human immune system. DC-based cancer vaccines demonstrate high safety and good tolerability, effectively activating tumor-specific T cells and establishing immune memory in patients, thereby conferring long-term anti-tumor effects.By combining the two, the advantages of mRNA vaccines and DC vaccines can be effectively leveraged without the need for in vivo injection of immune adjuvants and mRNA encapsulation materials, thereby enhancing drug safety and tolerability while exerting potent and highly specific anti-tumor immune activity.

In 2018, Likang collaborated with the Chinese People's Liberation Army General Hospital to conduct an investigator-initiated trial (IIT) evaluating LK101 injection for the treatment of postoperative hepatocellular carcinoma patients. Study data demonstrated that LK101 injection exhibited favorable safety and tolerability, with no grade I or higher drug-related adverse events reported. Activation of anti-tumor neoantigen immune responses was detected in all patients. The experimental group showed significant advantages in both postoperative recurrence rates and survival rates.

Likang is an innovative enterprise specializing in personalized cancer immunotherapy drugs, founded in 2017 by a founding team composed entirely of local PhD holders. The company has established several key platforms, including the LNEA™ bioinformatics platform, the HATSP™ high-throughput antigen/T-cell receptor screening platform, an in vitro transcription mRNA technology platform, and a large-scale automated closed-system cell therapy manufacturing platform. Currently, Likang focuses on precision cancer immunotherapy and is comprehensively developing multiple pipelines based on its universal technology platforms, covering tumor neoantigen analysis and diagnostics, neoantigen cancer vaccines, and T-cell therapies, thereby fully unlocking the potential of tumor neoantigens.