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BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV) Developing Innovative Inhaled NanoAb Therapeutics for Multiple Indications, Including COVID-19

  • Current monoclonal antibody therapies less effective against emerging COVID-19 variants
  • BiondVax is developing an inhaled nanosized antibody (NanoAb) therapy for COVID-19 with human clinical Phase 1/2a results anticipated in 2023
  • The global monoclonal antibodies market was valued at $185.5 billion in 2021 and is projected to grow at a CAGR of 11.3% due to the rising prevalence of chronic diseases and demand for biologics
  • The biologics market size was valued at $366.5 billion in 2021 and is expected to reach $719.94 billion by 2030
According to a new study, new COVID-19 subvariants have become dominant in recent months, rendering some current vaccines and treatments less effective, which could results in a surge of breakthrough infections. To date, the BQ.1, BQ.1.1, XBB, and XBB.1 omicron subvariants are the most immune evasive variants of COVID-19 – causing 72% of new infections in the United States, according to data from the Centers for Disease Control and Prevention (https://ibn.fm/0n3vY). With scientists finding that these subvariants are “barely susceptible to neutralization” by vaccines, including the new omicron boosters, the immune response of people vaccinated and who had breakthrough infections with prior omicron variants are also weaker against subvariants (https://ibn.fm/fpdPg). The intended inhaled mechanism of delivery of BiondVax Pharmaceuticals’ (NASDAQ: BVXV) COVID-19 nanosized antibody (NanoAb) formulation may serve as a significant differentiator when compared to approved monoclonal antibodies, which are injected. Inhaled delivery has shown to be cheaper, more convenient, and likely safer for patients and providers. BiondVax recently reported data from a preclinical in vivo study indicating that compared to the control (placebo) group, hamsters treated with 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 average 30 times higher viral titers in their lungs at the end of the trial. BiondVax’s human clinical Phase 1/2a for the inhaled COVID-19 NanoAb therapy is anticipated in 2023. NanoAbs, also known as VHH-antibodies or Nanobodies, are alpaca-derived nanosized antibodies that exhibit multiple significant competitive advantages over existing antibody therapies, including stability at high temperatures, superior binding affinity, more effective and convenient routes of administration, and efficient production. BiondVax is uniquely positioned to advance nanosized antibody innovation from R&D through commercialization. The biologics market size was valued at $366.5 billion in 2021, and is expected to grow at a CAGR of 7.15%, reaching $719.94 billion by 2030. The approval of new biologic drugs is expected to further drive market growth during the forecast period and account for a significant share in 2021 (https://ibn.fm/90rgZ). BiondVax is focused on developing, manufacturing, and commercializing innovative immunotherapeutic products, primarily for the treatment of infectious diseases and autoimmune diseases. The company has an exclusive strategic collaboration with the Max Planck Society – the parent organization of the Max Planck Institute for Multidisciplinary Sciences – and the University Medical Center Göttingen (“UMG”) for the development and commercialization of innovative NanoAb therapies starting with COVID-19. With highly experienced pharmaceutical industry leadership, BiondVax is aiming to develop a pipeline of diversified and commercially viable products and platforms, beginning with an innovative NanoAb pipeline. Since its inception, BiondVax has executed eight clinical trials, including a seven-country, 12,400-participant Phase 3 trial of its prior influenza vaccine candidate. It has built a state-of-the-art manufacturing facility for biopharmaceutical products and is pursuing NanoAb therapies for additional disease indications with large market medical needs, such as asthma, psoriasis, macular degeneration, and psoriatic arthritis. 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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