BiondVax Pharmaceuticals Ltd. announced additional results in a preclinical in vivo proof-of-concept study of its innovative inhaled nanosized antibody (NanoAb) 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 (p<0.0005) less than the amount of virus detected in the placebo group. The first (experimental) group was treated with BiondVax's anti-COVID-19 NanoAb, administered via inhalation, starting 24 hours after being infected, while the second (control) 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 (TCID50) 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 (p<0.001). 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. The study is using an industry-standard animal model for COVID-19 therapeutics and vaccines.

Weight loss is the key parameter for assessing disease severity in hamsters used as experimental animals in development of therapeutics and vaccines for COVID-19 disease. As noted in the paper titled Hamsters as a Model of Severe Acute Respiratory Syndrome Coronavirus-2, hamsters are “an ideal animal model of SARS-CoV-2 infections because they recapitulate many aspects of human infections.” The paper noted that weight loss in hamsters was reduced when treated with REGN-COV-2, a human mAb combination therapy that ultimately received FDA approval for SARS-CoV-2 treatment. A similar model was also used by Pfizer when developing Paxlovid, as noted in the paper titled the oral protease inhibitor (PF-07321332) protects Syrian hamsters against infection with SARS-CoV-2 variants of concern.

The study is being conducted by two world-renowned institutions: The Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM) and The University of Veterinary Medicine Hannover (TiHo), Germany. 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 fourth quarter of 2023. As part of a strategic research collaboration with the Max Planck Institute for Multidisciplinary Sciences and the University Medical Center Göttingen, BiondVax is developing a pipeline of innovative alpaca-derived nanosized antibody (NanoAb) therapies addressing diseases with large underserved medical needs and attractive commercial opportunities, such as COVID-19, asthma, psoriasis, psoriatic arthritis, and macular degeneration. While these diseases are currently treated with conventional monoclonal antibodies (mAbs), NanoAbs exhibit the potential to capture significant market share as biobetters.

In particular, as reported by Pfizer, Paxlovid has shown the demand for COVID-19 therapeutic treatments with approximately $22 billion in sales projected for the year ended Dec. 31, 2022, even with significant limitations of use due to adverse cross-reactions with other drugs and several other comorbidity contraindications that limit its use. In contrast, NanoAbs exhibit strong potential for superior patient convenience, safety, and clinical outcomes, at lower costs.

For example, as demonstrated by this preclinical study, BiondVax's NanoAb is efficacious when administered through inhalation rather than by injection as with currently available COVID-19 mAb therapies. In addition, most of the currently approved mAbs for the treatment of COVID-19 are not sufficiently efficacious against the Omicron variants of concern (VoCs) while BiondVax's lead drug candidate demonstrated strong neutralization of all SARS-COV-2 VoCs from Wuhan through Omicron, including the recent BA4/5 and BQ1 sub-variants.