AIVITA’s patient-specific vaccine platform has been used to create treatments for multiple areas of cancer, with promising safety and efficacy reported to date.
AIVITA is evaluating AV-COVID-19 in a 180-participant Phase 2 clinical study in Indonesia, following a successful a Phase 1 clinical study showing highly favorable safety and preliminary efficacy. In a preclinical study, AIVITA observed multiple SARS-CoV-2 antigens reacting with natural immunoglobulins from COVID-19 convalescent patient serum, demonstrating them to be suitable immune targets for SARS-CoV-2 vaccine production. It was also observed that there was no damage during vaccine production when these antigens were loaded onto the dendritic cells. Importantly, these antigen-loaded dendritic cells mounted an immune response in lymphocytes from the same patient, showing immune activation from the vaccine. Vaccinated mice were also shown to produce antibodies and a cellular immune response very quickly, in a third party GLP setting.
A key benefit of AIVITA’s approach is its potential for rapid scalability and mass distribution. Given the right tools, any one of thousands of minimally-equipped laboratory settings nationwide, or worldwide, could manufacture the patient-specific vaccine using AIVITA’s proprietary reagents.
Dendritic cell-based treatments have been widely studied in the clinical setting, showing strong safety and antigen-specific efficacy for creating an adaptive immune response.
Each AV-COVID-19 vaccine is personalized to the individual receiving it, using equipment and methods widely available in clinics worldwide.
- The process begins with a blood draw
- The blood is enriched for monocytes, a type of white blood cell that plays a role in innate immune response
- The monocytes are differentiated into dendritic cells, an immune messenger cell
- SARS-CoV-2 antigens are loaded onto the dendritic cells
- Following incubation, the vaccine is ready for administration
Phase 1 (Indonesia): NCT04690387
Phase 1/2 (US): NCT04386252
Phase 2 (Indonesia): NCT05007496