Immunotherapy & DNA Vaccines
DNA vaccines and personalized immunotherapies hold immense promise in revolutionizing the field of medicine and public health.
DNA vaccines, often referred to as third-generation vaccines, use engineered plasmid DNA that encodes for a protein originating from the pathogen to induce an immunologic response in the host against bacteria, parasites, viruses, and even cancer cells. Currently, there is only one DNA vaccine approved for use in humans, but there are many assets in clinical trial evaluation for several diseases. VGXI has extensive experience supplying high-quality cGMP plasmids to support clinical trial testing of leading DNA vaccine candidates. Notably, VGXI is the exclusive cGMP plasmid manufacturing partner for The Institute for Molecular Medicine’s Phase 1 clinical supply of AV-1959D, a DNA vaccine aimed at Alzheimer’s Disease prevention.
In the context of personalized immunotherapies, customized plasmid DNA vaccines can be designed to encode antigens unique to a patient’s cancer cells to enhance the immune response’s specificity and effectiveness. For these small-scale applications, VGXI has created an accelerated manufacturing process suitable for personalized therapy applications that can deliver cGMP plasmid DNA in a fraction of the standard industry turnaround times without compromising product quality. We have successfully utilized this platform to manufacture clinical grade plasmid DNA in support of Geneos GT-30 Phase Ib/IIa clinical trial for advanced hepatocellular carcinoma (HCC) developed using their neoantigen-targeting personalized immunotherapy platform, GT-EPIC™.