BiondVax Pharmaceuticals Ltd. announced statistically significant (p<0.001) efficacy results in a preclinical in vivo proof-of-concept study of its innovative inhaled nanosized antibody (NanoAb) COVID-19 therapy. Study design: Using an industry-standard animal model for COVID-19 therapeutics and vaccines, the study compared weight loss in two groups of hamsters after infection with SARS-COV-2. The first (experimental) group was treated with BiondVax's anti-COVID-19 NanoAb, administered via inhalation, starting one day after being infected, while the second (control) group was treated in the same manner but with saline serving as a placebo. The study was conducted by two world renowned institutions: The Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM) and The University of Veterinary Medicine Hannover (TiHo), Germany.

Results: 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). The successful result was 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. NanoAb as mAb biobetter: As part of a strategic research collaboration with the Max Planck Institute for Multidisciplinary Sciences (MPG) and the University Medical Center Göttingen (UMG), 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) which generate billions of dollars in annual commercial sales, NanoAbs exhibit the potential to capture significant market share as biobetters. In particular, 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 monoclonal antibody therapies.

Next steps: This preclinical trial will continue in January 2023 with additional arms testing lower therapeutic doses and a prophylactic dose of the inhaled COVID-19 NanoAb. As well, the amount of live SARS-COV-2 virus in the lungs following treatment will be assessed in each of the study groups. The study will also evaluate safety parameters.

Results of the dosing study will inform design of future clinical studies of BiondVax's anti-COVID-19 inhaled NanoAb. In 2023, BiondVax will conduct a pre-clinical toxicity study as required by regulatory authorities for approval of human clinical trials. The Company will also 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 in patients which is planned for fourth quarter 2023.