• BiondVax Pharmaceuticals is a biotechnology company focused on developing, manufacturing, and commercializing innovative immunotherapeutic products
• The company’s alpaca-derived nanosized antibodies (“NanoAbs”) exhibit superior valuable competitive advantages over commercially available monoclonal antibodies (“mAbs”), including better specificity and affinity to the target, hyper-thermostability, and potential for more effective and convenient routes of administration
• Preclinical in vivo data have shown its lead drug candidate, the inhaled anti-SARS-CoV-2 NanoAb, led to a significantly shorter and milder illness, virtually eliminated the virus from the lungs, and effectively prevented illness when administered prophylactically
• BiondVax aims to fill the void in COVID-19 therapeutics and is forging ahead with clinical efforts needed to support this goal

With the COVID-19 disease now in its fourth year, questions abound about how the pandemic will be felt in 2023. The complex interaction of the vaccinations, available therapeutic drugs, newly emerging COVID-19 drugs, and natural immunity complicates the process of determining crucial parameters that can be used to make projections surrounding disease severity and extent of the spread of the SARS-CoV-2 virus (https://ibn.fm/6f3Ng). To further compound the issue, newly emerging Omicron subvariants have rendered previously effective and approved monoclonal antibody drugs virtually ineffective, leading to the Food and Drug Administration (“FDA”)’s withdrawal of their authorization. Plus, most observers agree that the progression and evolution of the variants remain largely unpredictable three years on.

If the unpredictability and daily developments have taught us anything, it is the need for improved therapeutics. Such a therapeutic should be able to deal with both the existing and new subvariants and variants of the virus. Jerusalem-based biotechnology company, BiondVax Pharmaceuticals (NASDAQ: BVXV), and its strategic collaborators, the Max Planck Institute for Multidisciplinary Science (“MPI”) and the University Medical Center Göttingen (“UMG”), may have cracked the code, with their VHH antibodies or nanosized antibodies (“NanoAbs”) as the cryptographic key.

In addition to COVID-19, BiondVax and its collaborators aim to target indications with large unmet medical needs and growing market sizes like psoriasis, asthma, macular degeneration, and psoriatic arthritis, all diseases with known and validated antibody drug targets. According to the company, this will help shorten development timelines and lower risk. Initially, BiondVax is concentrating on COVID-19, having developed an inhaled anti-SARS-CoV-2 NanoAb candidate with potentially superior therapeutic capabilities against COVID-19.

In particular, BiondVax’s NanoAb candidate has exhibited superior affinity to its SARS-CoV-2 target, neutralizing the virus, in vitro, at drug concentrations about 100x lower than those required by previously commercially available monoclonal antibodies (“mAbs”) (https://ibn.fm/7YmGD). In a subsequent ongoing preclinical in vivo study in a standard animal model,  data has shown that the anti-COVID-19 therapy virtually eliminated the virus from the lungs (https://ibn.fm/rRM6H) and prevented illness when administered prophylactically (https://ibn.fm/jQ4Vg). It also showed that the anti-SARS-CoV-2 NanoAb led to a significantly shorter and milder illness (https://ibn.fm/k2Kqy).

Generally, NanoAbs exhibit a number of competitive advantages over mAbs. Firstly, they demonstrate superior specificity and binding affinity to the target, which can increase safety and efficacy at lower doses, allowing production at a lower cost. Secondly, they exhibit hyper-thermostability at high temperatures, potentially enabling longer shelf life and voiding the need for enhanced cold chain storage and transport.

Furthermore, their small size also enables more effective and convenient routes of administration, including inhalation. (For perspective, current mAb therapies are generally administered intravenously in a hospital setting,) And while inhaled therapeutics can be difficult to develop, BiondVax is working with industry-leading companies and organizations to develop a cost-effective, convenient, and reliable drug-device product.

According to the company, NanoAbs exhibit the potential to capture significant market share as biobetters; biobetters target the same epitope as commercially available antibodies but have improved properties. BiondVax is particularly encouraged by the high demand for COVID-19 therapeutics, demonstrated partly by the ~$18.9 billion in sales reported by Pfizer Inc. (NYSE: PFE) in 2022 for its Paxlovid drug (https://ibn.fm/iEWKn), even with the drug’s limitations of use because of serious cross-reactions with other medications and multiple other comorbidity contraindications.

Another source of encouragement is that the COVID-19 NanoAb candidate has demonstrated strong neutralization of all Omicron variants of concern (“VoC”), showing superiority over the now-deauthorized COVID-19 mAbs, which are insufficiently efficacious against Omicron and its subvariants. With the preclinical in vivo data proving highly encouraging, BiondVax plans to undertake its first-in-human clinical trial in 2023.

BiondVax Pharmaceuticals is out to prove that great things come in Nano-sized molecules and is laser focused on developing, manufacturing, and commercializing NanoAb immunotherapeutic products for the treatment of infectious diseases and large market disorders.

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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