China’s first personalized tumor neoantigen vaccine has received NMPA approval to enter the clinical phase.
Release date:
2023-09-20
On March 15, 2023, the Center for Drug Evaluation (CDE) of the National Medical Products Administration updated its website with new data in the section on tacit approval for clinical trials. LK101 Injection, a personalized tumor neoantigen vaccine developed by Beijing Likang Life Science Technology Co., Ltd. (hereinafter referred to as “Likang”), has received tacit approval for clinical trials, with an indication of advanced solid tumors.
On March 15, 2023, the Center for Drug Evaluation (CDE) of the National Medical Products Administration updated its website with new data in the section on tacit approval for clinical trials. LK101 Injection, a personalized tumor neoantigen vaccine developed by Beijing Likang Life Science Technology Co., Ltd. (hereinafter referred to as “Likang”), has received tacit approval for clinical trials, with an indication of advanced solid tumors.
This is China’s first personalized tumor neoantigen vaccine to receive NMPA approval for clinical development, and also the first fully personalized mRNA‑editing product to be approved for clinical trials.
On December 22, 2022, Licon submitted an Investigational New Drug (IND) application for the LK101 injection to the National Medical Products Administration and received acceptance. The LK101 injection is Licon’s first fully independently developed core pipeline; it is a personalized tumor neoantigen vaccine delivered as an mRNA‑DC vaccine. By transfecting dendritic cells with mRNA encoding dozens of patient‑specific tumor antigen targets designed based on the patient’s own tumor mutation profile, this product combines the advantages of both mRNA vaccines and DC vaccines.
mRNA technology is highly versatile, capable of encoding multiple antigens in a single formulation, with rapid and efficient expression, making it ideally suited for the development of personalized cancer therapies. Dendritic cells (DCs), meanwhile, are the most specialized and potent antigen-presenting cells in the human immune system. DC-based tumor vaccines exhibit excellent safety and tolerability, effectively activating tumor‑specific T cells and establishing immunological memory within the patient, thereby conferring long‑lasting anti‑cancer effects. By combining these two approaches, the complementary advantages of mRNA vaccines and DC vaccines can be fully leveraged, while eliminating the need for in vivo administration of immune adjuvants or mRNA delivery carriers. This strategy not only elicits robust, highly specific antitumor immune responses but also enhances the safety and tolerability of the therapeutic agent.
In 2018, Likan collaborated with the General Hospital of the People’s Liberation Army to conduct an investigator-initiated clinical trial (IIT) evaluating LK101 injection in patients with postoperative hepatocellular carcinoma. Study data demonstrated that LK101 injection exhibits a favorable safety and tolerability profile, with no drug-related adverse events of Grade I or higher reported. Furthermore, all patients showed activation of anti-tumor neoantigen–specific immune responses in vivo, and the experimental group exhibited significantly superior rates of postoperative recurrence-free survival and overall survival.
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