BiondVax Pharmaceuticals Ltd. announced additional results in a preclinical proof-of-concept study of its innovative inhaled NanoAb COVID-19 drug. Using an industry-standard animal model, the study compared weight loss in two groups of hamsters. Hamsters administered a mid-sized 0.66mg dose of the NanoAb three hours prior to infection experienced no significant weight loss over the six-day trial, whereas the untreated control group's weight declined 12% on average, a highly statistically significant difference (p<0.0005).

The study's design is intended to mimic a real-world situation in which at-risk groups, such as the elderly, people with comorbidities, the immunocompromised, travelers, those attending densely packed social situations such as weddings, sporting events and flights, and front-line health care professionals, may proactively protect themselves ahead of potential exposure to SARS-CoV-2 using BiondVax's self--administered inhaled NanoAb therapy. These promising prophylactic results follow previously reported data from the same study indicating that compared to the control (placebo) group, hamsters treated with a 2mg dose of BiondVax's inhaled NanoAb one day after infection had negligible (below detection level) SARS-CoV-2 viral titers in their lungs, and experienced a milder and shorter illness in comparison to the placebo group that had at least 30-times higher viral titers in their lungs at the end of the trial. Furthermore, and being reported here for the first time, lung histopathology revealed that therapeutic inhalation of NanoAbs reduced damage to alveoli, pulmonary vessels, and the conductive system.

The study is using an industry-standard animal model for COVID-19 prophylactics, 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-COV2, 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. Next steps: This preclinical trial is continuing with additional arms testing lower therapeutic doses (0.66mg and 0.22mg).

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 preclinical 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 2023. NanoAb as mAb biobetter: 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 VHH-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 $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.