Candidate: Adjuvanted vaccine to protect against COVID-19
Category: VAX
Type: Combination of Medicago’s Coronavirus Virus-Like Particle (CoVLP) with Dynavax’s advanced adjuvant, CpG 1018™. Medicago plans to manufacture the COVID-19 vaccine antigen using its plant-based production platform, which uses the leaves of a plant as bioreactors to produce the S-spike protein which self-assemble into VLPs for use in the CoVLP vaccine candidate.
Status: Dynavax said August 13 it was awarded a $3.4 million grant from the Bill & Melinda Gates Foundation toward scaling up production batch size to allow for increased capacity of Dynavax’s CpG 1018 advanced adjuvant. That effort will support capacity of up to 750 million adjuvant doses annually, which can be further increased if needed, according to the company.
Medicago and Dynavax agreed to partner on a COVID-19 vaccine in July, announcing plans for a Phase I trial (NCT04450004) that is now recruiting patients. The trial will be designed to evaluate the safety and immunogenicity of three different dose levels of antigen combined with CpG 1018, and in parallel with an adjuvant from another undisclosed company, administered on a one- and two-dose vaccination schedule, given 21 days apart.
The companies reason that adding CpG 1018, the adjuvant contained in Dynavax’s FDA-approved adult hepatitis B vaccine, will enhance the immune response of Medicago’s COVID-19 vaccine, which may decrease the total amount of antigen needed per dose, thus providing more doses for more people.
The companies cited “encouraging” preclinical results that support advancing development of the vaccine, though their announcement offered no data. Upon successful trials and regulatory approval, Medicago and Dynavax said, initial vaccine doses are set to be delivered in the first half of 2021—with plans to increase production up to 100 million doses by the end of that year. Manufacturing is expected to multiply to up to 1 billion doses annually once Medicago completes a large-scale manufacturing facility in Quebec City, QC, Canada, by the end of 2023.
The companies also agreed to evaluate a broader collaboration encompassing other identified opportunities.
COVID-19: 200 Candidates and Counting
To navigate through the >200 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data.
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types:
● ANTIVIRAL
● VAX
● ANTIBODY
● RNA
