Likang Life Sciences has recently been granted implied approval by the National Medical Products Administration (NMPA) for the clinical trial of its innovative personalized neoantigen-targeted vaccine LK101 Injection for advanced solid tumors. This breakthrough marks the first of its kind in China and represents a significant milestone in innovative drug discovery pathways for cancer treatment. As Chinese pharma companies continue to explore new frontiers in cancer treatment, the approval of LK101 injection sets the stage for exciting developments in the field, says GlobalData, a leading data and analytics company.

Neoantigens are produced by specific tumor viruses, integrated into the genome and are abundantly expressed only in tumor cells with strong immunogenicity and tumor heterogeneity. Vaccines predicated on neoantigens therefore elicit truly tumor-specific T cell responses. Notably, results from the initial clinical studies of personalized neoantigen-based vaccines have shown robust tumor-specific immunogenicity and preliminary evidence of antitumor activity.

According to GlobalData’s Pharma Intelligence Center, there are currently four personalized cancer vaccines in clinical development by Chinese pharma and biotech companies in China, three vaccines are in Phase I and one vaccine is in Preclinical stage. Most of these vaccines have a subcutaneous mode of administration and are subunit vaccines type, except LK101, which is dendritic cell-based mRNA vaccine.

Anupama Mishra, Pharma Analyst at GlobalData, comments: “Vaccine-based immune responses have already been explored for the development of preventive vaccines for infectious diseases, but in oncology, the stimulation of a tumor-specific immune response is a novel concept. Currently, only four preventive cancer vaccines have been approved by the Food and Drug Administration (FDA) for the prevention of Human Papillomavirus (HPV) and Hepatitis B virus (HBV) infection related cancers.

“Notably, there are only two preventive cancer vaccines marketed in China for HPV infection related cancers. Personalized cancer vaccination is a potent strategy for triggering a broad-spectrum antitumor response. These vaccines can also be designed to help elicit immunological memory for long-lasting tumor control. Hence, there is a need to increase clinical investigations in this promising area.”

LK01 is the first homegrown personalized neoantigen-target based cancer vaccine and a dendritic cell (DC)-based mRNA vaccine. DC vaccines are said to have high safety and good tolerance to effectively activate tumor-specific T cells and establish immunological memory, resulting in long-term anti-cancer effects. This combination of mRNA vaccine and DC vaccine is a potential breakthrough, offering an effective and safe approach for patients.

Mishra concludes: “It is an inspiring move from Chinese companies to step into personalized cancer vaccine development, which is claimed to have potential for engaging in both the innate and adaptive immune systems to elicit long-lasting immunological memory that can control tumor and prevent relapse. Furthermore, the rapid approval of such therapies will strengthen the healthcare system in China and reduce cancer related hospitalizations and financial burden on patients.”