BiondVax announces results of preclinical study of inhaled COVID-19 therapy

BiondVax announced additional results in a preclinical in vivo proof-of-concept study of its innovative inhaled nanosized antibody COVID-19 therapy, namely that the presence of the SARS-COV-2 virus in the lungs of hamsters treated with BiondVax’s NanoAb was below detectable levels and significantly less than the amount of virus detected in the placebo group. The first group was treated with BiondVax’s anti-COVID-19 NanoAb, administered via inhalation, starting 24 hours after being infected, while the second group was treated in the same manner but with a placebo. The study’s design is intended to mimic a real-world situation in which treatment is provided well after, and not simultaneously, to the moment of infections. Six days after infection, compared to the placebo group, hamsters treated with BiondVax’s inhaled NanoAb not only had over 30 times lower SARS-COV-2 viral titers in their lungs as measured by median tissue culture infectious dose but also those levels were at the border of detection, suggesting potential virtual elimination of the virus from their lungs. These results were corroborated also by PCR. As reported on Nov. 29, 2022, the efficacy of BiondVax’s inhaled COVID-19 NanoAb is also supported by additional data from the same study showing that compared to their weight immediately prior to infection, the control group’s weight declined on average 12.01%, while the weight of the experimental group, which was administered BiondVax’s NanoAb through inhalation, declined on average only 3.80%, a highly statistically significant result. These successful results were further supported by eight other tracked parameters, including heart rate and social behaviors, that indicated the group treated with inhaled NanoAbs experienced a milder and shorter illness. This preclinical trial continues in Jan. 2023 with additional arms testing lower therapeutic doses and a prophylactic dose of the inhaled COVID-19 NanoAb. The study will also evaluate safety parameters. Results of the dosing study will inform the design of future studies of BiondVax’s anti-COVID-19 inhaled NanoAb. Specifically, in 2023, BiondVax is expected to conduct a pre-clinical toxicity study to assess safety as required by regulatory authorities for approval of human clinical trials. The Company is also expected to scale up its manufacturing processes to produce, at its GMP manufacturing site in Jerusalem, the NanoAbs for the first-in-human Phase 1/2a clinical trial, which is planned for Q4 2023.