BiondVax reports successful results in preclinical in vivo

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  • Hamsters infected with SARS-COV-2 and subsequently treated with inhaled anti-COVID-19 NanoAbs showed significantly less severe disease and faster recovery compared to infected hamsters treated with inhaled placebo
  • BiondVax’s nanoantibodies (NanoAbs) are formulated as a convenient, self-administered, home inhaled COVID-19 therapy
  • First clinical phase 1/2a human trial planned for 2023
  • The COVID-19 therapy is BiondVax’s first in a new pipeline of innovative alpaca-derived NanoAb therapies that address diseases with high under-medical needs and attractive commercial opportunities such as psoriasis and asthma

Jerusalem, Nov. 29, 2022 (GLOBE NEWSWIRE) — via InvestorWire – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) (“BiondVax”), a biotechnology company focused on developing, manufacturing and commercializing innovative immunotherapeutic products primarily for the treatment of infectious and autoimmune diseases, announced today statistically significant (p<0.001) efficacy results in a preclinical in vivo proof-of-concept study of its innovative COVID-19 therapy with inhaled nanoantibodies (NanoAb).

Study design: Using an industry-standard animal model for COVID-19 therapies 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 infection, while the second (control) group was treated similarly, but with saline that served as 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 Hanover (TiHo), Germany.

Results: Compared to their weight immediately prior to infection, the weight of the control group decreased by an average of 12.01%, while the weight of the experimental group, which received BiondVax’s NanoAb via inhalation, only decreased by an average of 3.80%, a highly statistical significant result (p< 0.001).

The successful outcome was further supported by eight other parameters monitored, including heart rate and social behavior, which indicated that 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 Göttingen University Medical Center (UMG), BiondVax is developing a pipeline of innovative alpaca-derived nanoantibody (NanoAb) therapies to address 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 have the potential to capture significant market share as biobetters. In particular, NanoAbs show strong potential for superior patient convenience, safety and clinical outcomes, at a lower cost. For example, as demonstrated by this preclinical study, BiondVax’s NanoAb is efficacious when administered via inhalation rather than injection, as with currently available COVID-19 monoclonal antibody therapies.

WWe are pleased that the study results confirm the inhalation concept of our exclusively licensed NanoAb as a therapy for COVID-19 disease.” said BiondVax’s Chief Science Officer (CSO), dr. Tamar Ben-Yedididia PhD. “Following these promising results, we plan to continue the study early next year by testing additional dose levels of the inhaled NanoAb therapy and as a prophylactic (preventive) treatment. The results of the trial will inform the design of the first human clinical trial of the inhaled NanoAb COVID-19 therapy, which is scheduled to open in late 2023.

Ben-Yedidia concluded: “On behalf of the BiondVax team, I would like to thank the Fraunhofer ITEM and TiHo teams for their professionalism in conducting this ongoing study, as well as our research partners Professor Dr. Dirk Görlich from the Max Planck Institute for Multidisciplinary Sciences (MPG) and Professor Dr. Matthias Dobbelstein from Göttingen University Medical Center and their teams for the continued collaboration.

Mr Amir ReichmanCEO of BiondVax, added: “Recent articles have highlighted the limitations of existing therapies, especially Paxlovid (Pfizer) in high-risk populations, the absence of monoclonal antibodies highly effective against Omicron, and the need for new improved treatments to prevent serious disease. In addition, the use of COVID-19 vaccinations and boosters is declining. We believe that our NanoAb inhaled medicinal product can address this unmet need with a patient-friendly route of administration directly to the original source of infection.”

Next steps: This preclinical study will continue in January 2023 with additional arms testing lower therapeutic doses and a prophylactic dose of the inhaled COVID-19 NanoAb. The amount of live SARS-COV-2 virus in the lungs after treatment will also be assessed in each of the study groups. The study will also evaluate safety parameters. The results of the dosing study will guide the design of future clinical trials of BiondVax’s anti-COVID-19 inhaled NanoAb. In 2023, BiondVax will conduct a preclinical toxicity study as required by regulatory authorities for human clinical trial approval. The company will also scale up its manufacturing processes to produce the NanoAbs at its GMP manufacturing site in Jerusalem for the first-in-human Phase 1/2a clinical trial in patients, scheduled for Q4 2023.

About BiondVax
BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) is a biotechnology company focused on developing, manufacturing and commercializing innovative immunotherapeutic products primarily for the treatment of infectious and autoimmune diseases. Since inception, BiondVax has conducted eight clinical trials, including a Phase 3 trial in seven countries with 12,400 participants of its previous vaccine candidate, and built a state-of-the-art biopharmaceutical manufacturing facility. With highly experienced leadership in the pharmaceutical industry, BiondVax is committed to developing a pipeline of diversified and commercially viable products and platforms, starting with an innovative nano-antibody (NanoAb) pipeline. www.biondvax.com.

Contact details
Investor Relations | +972 8 930 2529 | ir@biondvax.com

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Litigation Reform Act of 1995. Words such as “expect,” “believe,” “intend,” “plan,” “continue,” “may,” “will,”” anticipate” and similar expressions are intended to identify forward-looking statements. All statements, other than statements of historical fact, contained in this announcement regarding strategy, future operations, future financing, future financial position, future revenues, expected expenses, prospects, plans and objectives of management are forward-looking statements. . Examples of such statements include, but are not limited to, the therapeutic and commercial potential of nanosized antibodies (NanoAbs); and the timing of NanoAb proof-of-concept studies and clinical trials. These forward-looking statements reflect management’s current views regarding certain current and future events and are subject to various risks, uncertainties and assumptions that could cause results to differ materially from those anticipated by management of BiondVax Pharmaceuticals Ltd . Risks and uncertainties include, but are not limited to, the risk of delay in proof-of-concept studies and initiation of clinical trials for NanoAbs, if any; the risk that the Company will raise no or no capital on acceptable terms, the risk that the Company will not file a compliance plan acceptable to Nasdaq, the risk that the therapeutic and commercial potential of NanoAbs will not be achieved; the risk of partial or total failure of clinical trials involving NanoAbs; the risk that BiondVax may not or be unable to secure additional capital on attractive terms; risks related to the COVID-19 (coronavirus) pandemic; BiondVax’s ability to acquire rights to additional product capabilities; BiondVax’s ability to enter into partnerships on terms acceptable to BiondVax or not at all; timing of receipt of regulatory approval of BiondVax’s manufacturing facility in Jerusalem, if or when required; the risk that the production facility cannot be used for a wide variety of applications and other vaccine and treatment technologies; and the risk that drug development involves a lengthy and expensive process with uncertain outcomes. More detailed information about the risks and uncertainties affecting the Company is included under the heading “Risk Factors” in the Company’s Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 28, 2022. BiondVax is not obliged to update any forward-looking statement for any reason.

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