AIVITA Biomedical announced the completion of a Phase 1 clinical study in Indonesia of its personalized vaccine candidate, AV-COVID-19, for the novel coronavirus (SARS-CoV-2).

The 27-participant Phase 1 study showed the treatment was well-tolerated, with no serious adverse events, and that treated individuals produced antibodies. The clinical program is being conducted by PT AIVITA Biomedika Indonesia, a joint venture established between AIVITA and local partners with support from the government of Indonesia. AV-COVID-19 is being manufactured locally by AIVITA. AIVITA is in discussions with regulatory authorities for a Phase 2 study in Indonesia, as well as clinical investigation of AV-COVID-19 in the United States in early 2021.

"We continue to see unprecedented global need for preventative vaccines that can be rapidly scaled and adapted to provide protection against all COVID-19 viral variants," said Hans Keirstead, Ph.D., chief executive officer of AIVITA. "Our personalized vaccine can be created locally to support regional economic stimulation, using a kit that can be produced rapidly at scale. In addition, our materials can be adapted to quickly create new vaccines against mutations of the virus. With this de-centralized model, we can conduct studies in Indonesia while moving toward a clinical trial in the United States early this year, and prepare for worldwide distribution."

AV-COVID-19 was created using AIVITA's autologous cell therapy platform, which has generated multiple therapeutic vaccine programs shown to be safe and effective in early clinical trials for difficult to treat cancers. Vaccine production begins with a basic blood draw from an individual, from which autologous immune cells are extracted using AIVITA's validated methodologies. These cells are loaded with multiple recombinant SARS-CoV-2 spike antigens to create a vaccine that is specific to each individual. The resulting cells are re-administered to the individual, with the purpose of creating fast immune protection against the coronavirus. A kit containing all materials is provided to local sites, which can carry out steps with minimal equipment, to de-centralize manufacturing.

In preclinical studies, AIVITA has shown that multiple SARS-CoV-2 antigens reacted with natural immunoglobulin antibodies from COVID-19 convalescent patient serum, showing that these antigens are suitable immune targets for SARS-CoV-2 vaccine production. The multiple antigens were loaded onto the dendritic cells and the resulting vaccine mounted an appropriate immune response in lymphocytes from the same recipient. Vaccinated mice were also shown to produce antibodies and a strong cellular immune response very quickly, in a third party GLP setting.