Intravacc, a world leader in
translational research and development of preventive and therapeutic vaccines,
today announced additional favorable preclinical and toxicology data for Avacc 10®, the company’s
SARS-CoV-2 intranasal candidate vaccine. These results demonstrate a reduction
in upper respiratory tract viral load, broad cross protection against
circulating variants of concern. and a good safety profile, allowing
progression towards a phase I clinical study.
Dr. Jan
Groen, Intravacc’s Chairman & CEO, comments:
“Based on our
additional pre-clinical data, Avacc 10® has the potential to reduce the spreading of the virus as well as
providing broad protection against circulation variants. Combined with the
favorable toxicological safety data, this puts us a good position for our Phase
I clinical trial, which will commence in Q4 2022."
The first set of
pre-clinical studies of Avacc 10®, published in Frontiers of Immunology in December 2021, demonstrated high levels of spike-binding immunoglobulin G (IgG) and A
(IgA) antibodies in serum, and the nose and lungs after two intranasal
vaccinations 3 weeks apart. Avacc
10® vaccinated hamsters
challenged with SARS-CoV-2 were protected from weight loss and viral
replication in the lungs and histopathology showed no lesions in lungs 7 days
after challenge.
The objectives of the additional pre-clinical and
toxicology study of Avacc 10® were to study the
dosing, cross neutralization and safety of the intranasal vaccine. For the
dosing study, mice were vaccinated intranasally with two doses of various
concentrations of OMV and Spike protein. Three weeks after the last vaccination
neutralizing antibodies against the SARS-CoV-2 Wuhan strain and variants of
concern Delta, Gamma and Omicron were determined in the sera. High virus
neutralizing antibody titers were detected against all the variant viruses.
Syrian hamsters were used to study viral replication after challenge with
SARS-CoV-2. A reduced viral load in throat and lungs and highly reduced lung
lesions were observed in Avacc 10® vaccinated animals
exposed to placebo vaccinated, challenged animals. Furthermore, delayed
transmission of Avacc 10® vaccinated, challenged animals to placebo
vaccinated animals was observed.
The purpose of the
repeated dose toxicity study was to assess the safety and tolerability of Avacc 10® when administered through the intranasal route
in New Zealand White Rabbits. Animals were vaccinated 3 times with Avacc 10® , and control animals with OMV only, or saline
buffer. Toxicity was monitored until 2 weeks after the final vaccination. No
clinical signs of toxicity nor morbidity/mortality were found in any of the
groups, and no gross pathological changes were observed, demonstrating the
safety of OMV based vaccine. All Avacc 10® vaccinated animals showed high IgG
antibodies levels against Spike as well as virus neutralizing antibodies.
Based
on the outcome of the Phase I trial, Intravacc will seek manufacturing and
commercialization license partners.
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