BiondVax’s Innovative Inhaled COVID-19 Therapy Virtually Eliminated SARS-COV-2 Virus in Preclinical In Vivo Study

• Hamsters contaminated with SARS-COV-2 after which handled with BiondVax’s inhaled anti-COVID-19 nanosized antibodies (NanoAbs) had over 30-times decrease lung viral titer on common in comparison with these handled with inhaled placebo
• Result builds on lately introduced knowledge indicating NanoAb remedy led to considerably milder sickness and quicker restoration in comparability to the placebo group
• BiondVax’s NanoAbs are being formulated as a handy self‑administered inhaled drug for remedy and potential prophylactic prevention of COVID-19  
• First-in-human Phase 1/2a medical trial deliberate for 2023
• The COVID-19 remedy is BiondVax’s first in a brand new pipeline of revolutionary alpaca-derived NanoAb therapies addressing ailments with giant underserved medical wants and enticing business alternatives comparable to psoriasis and bronchial asthma

JERUSALEM, Jan. 06, 2023 (GLOBE NEWSWIRE) — through InvestorWire – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biotechnology firm targeted on growing, manufacturing and commercializing revolutionary immunotherapeutic merchandise primarily for the remedy of infectious and autoimmune ailments, lately introduced further outcomes in a preclinical in vivo proof-of-concept research of its revolutionary inhaled nanosized antibody (NanoAb) COVID-19 remedy, specifically that the presence of the SARS-COV-2 virus in the lungs of hamsters handled with BiondVax’s NanoAb was beneath detectable ranges and considerably (p<0.0005) lower than the quantity of virus detected in the placebo group.

The first (experimental) group was handled with BiondVax’s anti-COVID-19 NanoAb, administered through inhalation, beginning 24 hours after being contaminated, whereas the second (management) group was handled in the identical method however with a placebo. The research’s design is meant to imitate a real-world state of affairs in which remedy is supplied nicely after, and never concurrently, to the second of infections.

Six days after an infection, in comparison with the placebo group, hamsters handled with BiondVax’s inhaled NanoAb not solely had over 30 occasions decrease SARS-COV-2 viral titers in their lungs as measured by median tissue tradition infectious dose (TCID50) but in addition these ranges have been on the border of detection, suggesting potential digital elimination of the virus from their lungs. These outcomes have been corroborated additionally by PCR.

As reported on Nov. 29, 2022, the efficacy of BiondVax’s inhaled COVID-19 NanoAb can also be supported by further knowledge from the identical research exhibiting that in comparison with their weight instantly previous to an infection, the management group’s weight declined on common 12.01%, whereas the burden of the experimental group, which was administered BiondVax’s NanoAb by means of inhalation, declined on common solely 3.80%, a extremely statistically vital consequence (p<0.001). These profitable outcomes have been additional supported by eight different tracked parameters, together with coronary heart fee and social behaviors, that indicated the group handled with inhaled NanoAbs skilled a milder and shorter sickness.

Dr. Tamar Ben-Yedidia, BiondVax’s Chief Science Officer (CSO), defined, “These lung viral titer results indicate that our inhaled NanoAbs essentially eliminated viral presence in the lungs, and led to a shorter and milder illness. This data is unequivocal and exciting. We’re looking forward to continuing this study this month by testing additional dose levels of the inhaled NanoAb therapy and as a prophylactic (preventive) treatment. Results of the trial will inform design of the first-in-human clinical trial of the inhaled NanoAb COVID-19 therapy, which is planned for late 2023.”

Amir Reichman, BiondVax’s CEO, acknowledged, “We are thrilled with the results of this ongoing trial. This study is not only a proof-of-concept for the inhaled COVID-19 NanoAb, but also lights the way to development of a larger NanoAb pipeline. The current Omicron outbreak in China has demonstrated that continuous development of innovative and safe therapeutics for COVID-19 is the more effective and economical way to contain this disease. Having a self-administered inhaled therapeutic for those already infected that may also be used as prophylactic prevention for those at risk will address current unmet needs, potentially bring massive relief to global public health, and save millions of lives going forward. I’m proud of the BiondVax team who are scaling-up in-house manufacturing of the NanoAbs and are already beginning to prepare for the next NanoAbs as therapies for other underserved medical conditions such as psoriasis and asthma.”

The research is utilizing an industry-standard animal mannequin for COVID-19 therapeutics and vaccines. Weight loss is the important thing parameter for assessing illness severity in hamsters used as experimental animals in growth of therapeutics and vaccines for COVID-19 illness. As famous in the paper titled Hamsters as a Model of Severe Acute Respiratory Syndrome Coronavirus-2, hamsters are “an ideal animal model of SARS-CoV-2 infections because they recapitulate many aspects of human infections.” The paper famous that weight reduction in hamsters was lowered when handled with REGN-COV-2, a human mAb mixture remedy that in the end acquired FDA approval for SARS-CoV-2 remedy. The same mannequin was additionally utilized by Pfizer when growing Paxlovid, as famous in the paper titled The oral protease inhibitor (PF-07321332) protects Syrian hamsters in opposition to an infection with SARS-CoV-2 variants of concern.

The research is being performed by two world-renowned establishments: The Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM) and The University of Veterinary Medicine Hannover (TiHo), Germany.

Next steps: This preclinical trial continues in Jan. 2023 with further arms testing decrease therapeutic doses and a prophylactic dose of the inhaled COVID-19 NanoAb. The research may even consider security parameters. Results of the dosing research will inform the design of future research of BiondVax’s anti‑COVID‑19 inhaled NanoAb. Specifically, in 2023, BiondVax is anticipated to conduct a pre‑medical toxicity research to evaluate security as required by regulatory authorities for approval of human medical trials. The Company can also be anticipated to scale up its manufacturing processes to supply, at its GMP manufacturing website in Jerusalem, the NanoAbs for the first-in-human Phase 1/2a medical trial, which is deliberate for This autumn 2023.

NanoAb as mAb biobetter: As a part of a strategic analysis collaboration with the Max Planck Institute for Multidisciplinary Sciences and the University Medical Center Göttingen, BiondVax is growing a pipeline of revolutionary alpaca‑derived nanosized antibody (NanoAb) therapies addressing ailments with giant underserved medical wants and enticing business alternatives, comparable to COVID-19, bronchial asthma, psoriasis, psoriatic arthritis, and macular degeneration. While these ailments are presently handled with standard monoclonal antibodies (mAbs), NanoAbs exhibit the potential to seize vital market share as biobetters. In explicit, as reported by Pfizer, Paxlovid has proven the demand for COVID-19 therapeutic remedies with ~$22 billion in gross sales projected for the 12 months ended Dec. 31, 2022, even with vital limitations of use attributable to adversarial cross-reactions with different medicine and several other different comorbidity contraindications that restrict its use. In distinction, NanoAbs exhibit sturdy potential for superior affected person comfort, security, and medical outcomes, at decrease prices. For instance, as demonstrated by this preclinical research, BiondVax’s NanoAb is efficacious when administered by means of inhalation relatively than by injection as with presently obtainable COVID-19 mAb therapies. In addition, many of the presently authorised mAbs for the remedy of COVID-19 usually are not sufficiently efficacious in opposition to the Omicron variants of concern (VoCs) whereas BiondVax’s lead drug candidate demonstrated sturdy neutralization of all SARS-COV-2 VoCs from Wuhan by means of Omicron, together with the current BA4/5 and BQ1 sub-variants.

About BiondVax
BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) is a biotechnology firm targeted on growing, manufacturing, and commercializing revolutionary immunotherapeutic merchandise primarily for the remedy of infectious and autoimmune ailments. Since its inception, BiondVax has executed eight medical trials together with a seven-country, 12,400-participant Phase 3 trial of its prior vaccine candidate and has constructed a state-of-the-art manufacturing facility for biopharmaceutical merchandise. With extremely skilled pharmaceutical {industry} management, BiondVax is aiming to develop a pipeline of diversified and commercially viable merchandise and platforms starting with an revolutionary nanosized antibody (NanoAb) pipeline. www.biondvax.com.

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

Forward-Looking Statements

This press launch accommodates forward-looking statements inside the which means of the Private Litigation Reform Act of 1995. Words comparable to “expect,” “believe,” “intend,” “plan,” “continue,” “may,” “will,” “anticipate,” and related expressions are supposed to establish forward-looking statements. All statements, apart from statements of historic information, included in this communication concerning technique, future operations, future financings, future monetary place, future income, projected bills, prospects, plans and aims of administration are forward-looking statements. Examples of such statements embody, however usually are not restricted to, the therapeutic and business potential of nanosized antibodies (NanoAbs); and the timing of NanoAb proof-of-concept research and medical trials. These forward-looking statements mirror administration’s present views with respect to sure present and future occasions and are topic to numerous dangers, uncertainties and assumptions that might trigger the outcomes to vary materially from these anticipated by the administration of BiondVax Pharmaceuticals Ltd. Risks and uncertainties embody, however usually are not restricted to, the danger of a delay in proof-of-concept research and the graduation of medical trials for NanoAbs, if any; the danger that the therapeutic and business potential of NanoAbs won’t be met; the danger that medical trials regarding NanoAbs will fail in complete or in half; the danger that BiondVax could not be capable to safe further capital on enticing phrases, if in any respect; dangers regarding the COVID-19 (coronavirus) pandemic; BiondVax’s capability to accumulate rights to further product alternatives; BiondVax’s capability to enter into collaborations on phrases acceptable to BiondVax or in any respect; timing of receipt of regulatory approval of BiondVax’s manufacturing facility in Jerusalem, if in any respect or when required; the danger that the manufacturing facility will be unable for use for all kinds of purposes and different vaccine and remedy applied sciences, and the danger that drug growth entails a prolonged and costly course of with unsure outcomes. More detailed details about the dangers and uncertainties affecting the Company is contained beneath 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 undertakes no obligation to revise or replace any forward-looking assertion for any motive.

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