VBI Eyes Year-End Launch of COVID-19 Vaccine Clinical Trials

Inside Precision Medicine Staff Writer

September 4, 2020

VBI Eyes Year-End Launch of COVID-19 Vaccine Clinical Trials — Illustration of antibodies (red and blue) responding to an infection with the new coronavirus SARS-CoV-2 (purple). The virus emerged in Wuhan, China, in December 2019, and causes a mild respiratory illness (covid-19) that can develop into pneumonia and be fatal in some cases. The coronaviruses take their name from their crown (corona) of surface proteins, which are used to attach and penetrate their host cells. Once inside the cells, the particles use the cells' machinery to make more copies of the virus. Antibodies bind to specific antigens, for instance viral proteins, marking them for destruction by other immune cells.

VBI Vaccines reported data from three preclinical mouse studies conducted to enable selection of optimized clinical candidates for the company’s VBI-2900 coronavirus program. As a result of these studies, VBI has selected two vaccine candidates, with the potential to be one-dose vaccines, to take into an adaptive Phase I/II human clinical study, expected to begin around year-end 2020, subject to regulatory approval.

The candidates are VBI-2901, a trivalent pan-coronavirus vaccine candidate expressing the SARS-CoV-2 (COVID-19), SARS-CoV (SARS), and MERS-CoV (MERS) spike proteins, and VBI-2902, a monovalent vaccine candidate expressing the SARS-CoV-2 (COVID-19) spike protein.

In August, VBI entered into an agreement with a CDMO, Therapure Biomanufacturing, for development and manufacturing services in preparation for production of its coronavirus vaccine candidates. The collaboration with Therapure is expected to enable the initiation of clinical studies by the end of 2020. As part of the agreement, Therapure will manufacture bulk vaccine for use through Phase II clinical studies.