- BiondVax’s preclinical proof-of-concept study was designed to mimic a real-world situation regarding at-risk groups, including the elderly, people with comorbidities, the immunocompromised, travelers, those attending densely packed social events, and front-line healthcare workers
- The study shows promising prophylactic results with hamsters receiving BiondVax’s inhaled NanoAb three hours before infection experiencing no significant weight loss over the six-day trial; follows previously reported data showing successful use of NanoAb as COVID-19 therapeutic
- First-in-human Phase 1/2a clinical trial is planned for later this year
Focused on the development, manufacture, and commercialization of innovative NanoAb immunotherapeutic products, BiondVax Pharmaceuticals (NASDAQ: BVXV) recently announced additional results in the company’s preclinical proof-of-concept study of its inhaled nanosized VHH-antibody (NanoAb) COVID-19 drug (https://ibn.fm/Kz8W4). BiondVax is developing a pipeline of innovative alpaca-derived NanoAb drugs addressing diseases with large underserved medical needs and attractive commercial opportunities, such as COVID-19, asthma, psoriasis, psoriatic arthritis, and macular degeneration. The research is being done as part of a collaboration with the Max Planck Institute for Multidisciplinary Sciences and the University Medical Center Göttingen.
The study was designed to mimic a real-world situation in which at-risk groups, including the elderly, people with comorbidities, the immunocompromised, travelers, those attending densely packed social events, and front-line healthcare professionals may proactively protect themselves prior to potential SARS-CoV-2 exposure using BiondVax’s self-administered inhaled NanoAb therapy.
Using an industry-standard animal model, the study compared weight loss in two groups of hamsters. The hamsters administered a mid-sized 0.66mg dose of the NanoAb three hours before infection experienced no significant weight loss over the six-day trial. In contrast, the hamsters in the untreated control group experienced a 12% decline in weight, a highly statistically significant difference (p<0.0005).
The 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 compared to the placebo group that had at least 30-times higher viral titers in their lungs at the end of the trial. Additionally, lung histopathology revealed that therapeutic inhalation of NanoAbs reduced damage to alveoli, pulmonary vessels, and the conductive system.
“We continue to be thrilled with the results of this ongoing trial. There is strong market demand for COVID prophylactics as evidenced by AstraZeneca’s reported Q1 through Q3 2022 EVUSHELD revenues of $1.5 billion. EVUSHELD is currently the only prophylactic COVID medication with FDA approval under emergency use authorization,” BiondVax CEO Amir Reichman said. “Our inhaled NanoAb is designed to be self-administered at the time of choosing to generate rapid protection from COVID illness. In contrast, EVUSHELD must be administered via two separate consecutive intramuscular (‘IM’) injections in a health care setting… we believe the additional ‘biobetter’ value provided by our NanoAb potentially positions it to capture significant market share both for treatment and prevention of COVID illness.”
The preclinical trial’s next step is to continue with additional arms testing lower therapeutic doses. It will also evaluate safety parameters. The results of the dosing study will inform the design of future studies of BiondVax’s inhaled NanoAb expected in 2023, including a preclinical toxicity study to assess safety as required by regulatory authorities for approval of human clinical trials. BiondVax is also expected to scale up its manufacturing processes to produce, at its Jerusalem GMP manufacturing facility, the NanoAbs for the first-in-human Phase 1/2a clinical trial planned for Q4 2023.
For more information, visit the company’s website at www.BiondVax.com.
NOTE TO INVESTORS: The latest news and updates relating to BVXV are available in the company’s newsroom at https://ibn.fm/BVXV
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