Likang Life Sciences has been granted implied approval by China’s National Medical Products Administration (NMPA) for the clinical trial of its innovative personalised neoantigen-targeted vaccine LK101 Injection for advanced solid tumours.
This breakthrough marks the first of its kind in China and represents a significant milestone in innovative drug discovery pathways for cancer treatment.
According to data and analytics company Globaldata, the approval of LK101 injection sets the stage for exciting developments in the field.
Neoantigens are produced by specific tumour viruses, integrated into the genome and are abundantly expressed only in tumour cells with strong immunogenicity and tumour heterogeneity.
Vaccines predicated on neoantigens therefore elicit truly tumour-specific T cell responses. Notably, results from the initial clinical studies of personalised neoantigen-based vaccines have shown robust tumour-specific immunogenicity and preliminary evidence of antitumour activity.
According to GlobalData’s Pharma Intelligence Center, there are currently four personalised cancer vaccines in clinical development in China. Most of these vaccines have a subcutaneous mode of administration and are subunit vaccines, except LK101, which is dendritic cell-based mRNA vaccine.
Anupama Mishra, Pharma Analyst at GlobalData, commented: “Vaccine-based immune responses have already been explored for the development of preventive vaccines for infectious diseases, but in oncology, the stimulation of a tumour-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. Personalised cancer vaccination is a potent strategy for triggering a broad-spectrum antitumour response. These vaccines can also be designed to help elicit immunological memory for long-lasting tumour control. Hence, there is a need to increase clinical investigations in this promising area.”