Dynavax Technologies has announced the commencement of dosing in a Phase I clinical trial of Medicago’s plant-derived Covid-19 vaccine candidate adjuvanted with Dynavax’s CpG 1018.
The companies previously partnered to combine Medicago’s Coronavirus Virus-Like Particle (CoVLP) with Dynavax’s CpG 1018.
An adjuvant is expected to boost immune response and lower the amount of antigen required per dose, enabling the availability of more doses.
Dynavax Technologies CEO Ryan Spencer said: “CpG 1018’s ability to enhance the immune response, as successfully demonstrated in HEPLISAV-B, is expected to reduce the dose of antigen needed, helping ensure broader availability to patients.
“Additionally, the unique mechanism of action of CpG 1018 may provide important enhancements including increased protection in populations traditionally less responsive to vaccination such as older adults who are at greatest risk for severe disease from Covid-19.”
The randomised, partially-blinded, prime-boost, staggered dose-escalation Phase I trial will evaluate the safety, tolerability, and immunogenicity of the Covid-19 vaccine candidate at three dose levels.
During the study, the vaccine candidate will be unadjuvanted or adjuvanted with either CpG 1018 or another company’s adjuvant. A total of around 180 healthy volunteers aged 18 to 55 will be enrolled.
Preliminary safety and immunogenicity data are expected in October this year. Medicago is planning to conduct a Phase II/III trial in October.
Medicago Scientific and Medical Affairs executive vice-president Nathalie Landry said: “We are thrilled to see our Covid-19 vaccine candidate enter the Phase I trial, and we look forward to obtaining safety and immunogenicity results in October.
“Our progress continues to demonstrate the value of Medicago’s unique plant-based vaccine technology.”
Medicago’s plant-based production platform will be used to manufacture the Covid-19 vaccine antigen. The platform uses plants as mini-factories to create proteins that self-assemble into the virus-like particles used in the CoVLP vaccine candidate.
With Medicago’s technology in combination with Dynavax’s adjuvant, the companies estimate to produce up to 100 million doses by the end of next year.
Medicago expects to complete the construction of a large-scale manufacturing facility in Quebec City, Canada by the end of 2023, increasing its potential production capacity to up to one billion vaccine doses per year.