Everest Medicines, a biopharmaceutical company based in China and listed on the Hong Kong Stock Exchange (HKG: 1952), has announced the commencement of an investigator-initiated trial (ITT) for its cutting-edge personalized mRNA cancer vaccine, EVM16. The trial, spearheaded by Beijing Cancer Hospital and Fudan University Shanghai Cancer Center, is a dosage escalation and expansion study aimed at evaluating the safety, tolerability, immunogenicity, and preliminary efficacy of EVM16 as a monotherapy or in combination with a PD-1 inhibitor for the treatment of advanced or recurrent solid tumors.
EVM16 is crafted from linearized plasmid DNA, utilizing a bacterial library as a template. The DNA is transcribed, purified, sterilized, and filtered to produce an mRNA stock solution. This solution is then encapsulated using lipid nanoparticle (LNP) technology, which envelops the mRNA within nanoscale lipid particles made of specific lipid components, and is further combined with other excipients for aseptic filling.
A cornerstone of EVM16’s innovation is the use of independently developed artificial intelligence algorithms that predict new antigens with high immunogenicity potential based on the unique tumor cell mutations of each patient. The LNP delivery system ensures the efficient delivery of mRNA expressing tumor new antigens into the human body. Upon administration, the mRNA is internalized by cells to produce new antigen peptides, stimulating a new antigen-specific T cell immune response designed to eliminate tumor cells expressing the new antigen, thus inhibiting tumor growth and addressing cancer.
Preclinical studies have shown that EVM16 can elicit robust neoantigen-specific T cell immune responses across various mouse models, with notable tumor growth inhibition in the B16F10 mouse melanoma model. The data also highlight the synergistic anti-tumor effects when EVM16 is combined with a PD-1 inhibitor, underscoring the potential of this personalized vaccine approach in conjunction with immune checkpoint inhibitors in clinical settings.- Flcube.com
