Medigen Vaccine Biologics Corp. (MVC) (TPEx 6547.TWO) today published preclinical results of their COVID-19 vaccine candidate in BioRxiv, a non-peer reviewed, open access preprint repository for the biological sciences:
Pre-print paper can be found here: bioRxiv
In the studies conducted, the S-2P antigen was combined with various adjuvants to determine best immune response, administered to mice to test its ability in eliciting SARS-CoV-2 neutralizing antibodies, and administered to rats to investigate safety.
Key findings:
- S-2P combined with adjuvants elicit effective neutralizing antibody in preclinical studies.
- S-2P in combination with CpG 1018 and alum was found to be the most potent immunogen and induced a high titer of spike-specific antibodies in sera of immunized mice.
- CpG 1018 is dominant over alum in directing the cell-mediated response towards a Th1 response, while retaining high antibody levels. A potential important finding for the possible preventions of vaccine-associated enhanced respiratory disease (VAERD) in humans.
- S-2P with CpG 1018 and alum was effective in inducing potent neutralization activity against both pseudovirus of Wuhan and European variants, as well as wild-type SARS-CoV-2, indicating the potential for broad spectrum protection.
- No vaccine-related serious adverse effects were found in the dose-ranging study in rats administered in single- and two-dose regimens with up to 50 μg of S-2P combined with CpG 1018 alone or CpG 1018 with alum.
- The two-dose regimen of S-2P formulated with CpG 1018 and alum induced potent neutralizing activity, and data justifies the evaluation of single-dose regimen in future studies.
- There were high degrees of correlation between neutralization titers of pseudovirus, wild-type virus, and anti-S IgG titers.
The data has been submitted to the Taiwan regulatory authorities (TFDA) and MVC expects to move forward with first-in-human clinical trials in the very near future.
Forward-Looking Statements
By their very nature, forward-looking statements for a development process involve inherent risks and uncertainties, both general and specific. Thus there is no assurance or guarantee that any predictions, forecasts, projections and other forward-looking statements will be achieved. Given the unprecedented circumstances of the COVID-19 pandemic, regulatory uncertainty, funding and rapid production development schedule, all numbers presented as well as schedule must be subject to adaptations and change.
Medigen Contact:
Paul Torkehagen,
Director, Overseas Business Development
paul@medigenvac.com