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BiondVax’s Revolutionary Inhaled Anti-SARS-CoV-2 NanoAb Nearly Prevented Sickness When Administered Prophylactically in Preclinical In Vivo Examine

  • COVID-19 sickness was just about prevented in hamsters administered BiondVax’s inhaled NanoAb and contaminated three hours later with SARS-CoV-2
  • Knowledge additional strengthens worth proposition of BiondVax’s COVID-19 NanoAb as prophylactic and therapeutic drug; Beforehand introduced knowledge indicated NanoAb therapy in the future put up an infection led to considerably milder sickness, sooner restoration, and decrease viral lung titer compared to the placebo group
  • First-in-human Part 1/2a medical trial is deliberate for 2023
  • The COVID-19 NanoAb is BiondVax’s first in a brand new pipeline of revolutionary NanoAb medication addressing ailments with massive underserved medical wants and engaging business alternatives comparable to psoriasis, bronchial asthma, psoriatic arthritis and moist AMD

JERUSALEM, Jan. 23, 2023 (GLOBE NEWSWIRE) — by way of InvestorWire –BiondVax Prescription drugs Ltd. (Nasdaq: BVXV), a biotechnology firm targeted on creating, manufacturing and commercializing revolutionary immunotherapeutic merchandise primarily for the therapy of infectious and autoimmune ailments, as we speak introduced extra ends in a preclinical proof-of-concept research of its revolutionary inhaled NanoAb COVID-19 drug. Utilizing an industry-standard animal mannequin, the research in contrast weight reduction in two teams of hamsters. Hamsters administered a mid-sized 0.66mg dose of the NanoAb three hours prior to an infection skilled no important weight reduction over the six-day trial, whereas the untreated management group’s weight declined 12% on common, a extremely statistically important distinction (p<0.0005).

The research’s design is meant to imitate a real-world scenario during which at-risk teams, such because the aged, folks with comorbidities, the immunocompromised, vacationers, these attending densely packed social conditions comparable to weddings, sporting occasions and flights, and entrance -line well being care professionals, might proactively shield themselves forward of potential publicity to SARS-CoV-2 utilizing BiondVax’s self-administered inhaled NanoAb remedy.

These promising prophylactic outcomes observe beforehand reported knowledge from the identical research indicating that in comparison with the management (placebo) group, hamsters handled with a 2mg dose of BiondVax’s inhaled NanoAb in the future after an infection had negligible (under detection stage) SARS-CoV-2 viral titers of their lungs, and skilled a milder and shorter sickness compared to the placebo group that had not less than 30-times increased viral titers of their lungs on the finish of the trial. Moreover, and being reported right here for the primary time, lung histopathology revealed that therapeutic inhalation of NanoAbs diminished harm to alveoli, pulmonary vessels, and the conductive system.

We proceed to be thrilled with the outcomes of this ongoing trial,” said amir reichmannBiondVax’s CEO. “There may be sturdy market demand for COVID prophylactics as evidenced by AstraZeneca’s reported Q1 by way of Q3 2022 EVUSHELD revenues of $1.5 billionone. EVUSHELD is at the moment the one prophylactic COVID remedy with FDA approval, underneath emergency use authorization. Our inhaled NanoAb is designed to be self-administered on the time of selecting to generate fast safety from COVID sickness. In distinction, EVUSHELD should beadministeredby way oftwo separate consecutive intramuscular (IM) injections in a well being care setting, and the FDA has confirmed it doesn’t successfully neutralize current Omicron variants of concern.2

“Knowledge from our trial point out that our NanoAb might successfully function each a therapeutic and protecting prophylactic drug, which additional enhances its worth proposition. COVID vaccine uptake is declining, effectiveness wanes over a brief time period, and vaccination campaigns demand huge well being care system assets. The way in which ahead should embrace efficient prophylactic and therapeutic medication. We imagine the extra ‘biobetter’ worth supplied by our NanoAb doubtlessly positions it to seize important market share each for therapy and prevention of COVID sickness,” mr reichman concluded.

BiondVax’s Chief Science Officer (CSO) Dr Tamar Ben-Yedidia defined, “We anticipate that our handy self-administered inhaled NanoAbs will probably be extremely engaging to at-risk folks wishing to proactively, successfully, conveniently, and safely shield themselves. This builds on the trial’s thrilling knowledge indicating that our NanoAbs may deal with COVID sickness after an infection. We stay up for finishing this preclinical trial and shifting in direction of a first-in-human Part 1/2a medical trial later this 12 months.”

The research is utilizing an industry-standard animal mannequin for COVID-19 prophylactics, therapeutics, and vaccines. Weight reduction 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 within the paper titled Hamsters as a Mannequin of Extreme Acute Respiratory Syndrome Coronavirus-2hamsters are “a perfect animal mannequin of SARS-CoV-2 infections as a result of they recapitulate many facets of human infections.” The paper famous that weight reduction in hamsters was diminished when handled with REGN-COV2, a human mAb mixture remedy that in the end acquired FDA approval for SARS-CoV-2 therapy. The same mannequin was additionally utilized by Pfizer when creating Paxlovid, as famous within the paper titled The oral protease inhibitor (PF-07321332) protects Syrian hamsters towards 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 Drugs (ITEM) and The College of Veterinary Drugs Hannover (TiHo), Germany.

Subsequent steps: This preclinical trial is continuous with extra arms testing decrease therapeutic doses (0.66mg and 0.22mg). The research may also consider security parameters. Outcomes of the dosing research will inform the design of future research of BiondVax’s anti‑COVID‑19 inhaled NanoAb. Particularly, in 2023, BiondVax is predicted to conduct a preclinical toxicity research to evaluate security as required by regulatory authorities for approval of human medical trials. The Firm can be anticipated to scale up its manufacturing processes to provide, at its GMP manufacturing web site in Jerusalem, the NanoAbs for the first-in-human Part 1/2a medical trial, which is deliberate for This fall 2023.

NanoAb as mAb biobetter: As a part of a strategic analysis collaboration with the Max Planck Institute for Multidisciplinary Sciences and the College Medical Heart Göttingen, BiondVax is creating a pipeline of revolutionary alpaca-derived nanosized VHH-antibody (NanoAb) therapies addressing ailments with massive underserved medical wants and engaging business alternatives, comparable to COVID-19, bronchial asthma, psoriasis, psoriatic arthritis, and macular degeneration. Whereas these ailments are at the moment handled with standard monoclonal antibodies (mAbs), NanoAbs exhibit the potential to seize important market share as biobetters. Particularly, 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 important limitations of use as a result of antagonistic cross-reactions with different medication 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 way of inhalation fairly than by injection as with at the moment accessible COVID-19 mAb therapies. As well as, a lot of the at the moment accepted mAbs for the therapy of COVID-19 will not be sufficiently efficacious towards the Omicron variants of concern (VoCs) whereas BiondVax’s lead drug candidate demonstrated sturdy neutralization of all SARS-CoV-2 VoCs from Wuhan by way of Omicron, together with the current BA4/5 and BQ1 sub-variants.

About BiondVax
BiondVax Prescription drugs Ltd. (Nasdaq: BVXV) is a biotechnology firm targeted on creating, manufacturing, and commercializing revolutionary immunotherapeutic merchandise primarily for the therapy of infectious and autoimmune ailments. Since its inception, BiondVax has executed eight medical trials together with a seven-country, 12,400-participant Part 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.

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Ahead-Trying Statements

This press launch comprises forward-looking statements throughout the which means of the Non-public Litigation Reform Act of 1995. Phrases comparable to “count on,” “imagine,” “intend,” “plan,” “proceed,” “might,” “will, ” “anticipate,” and related expressions are supposed to establish forward-looking statements. All statements, aside from statements of historic information, included on this communication concerning technique, future operations, future financings, future monetary place, future income, projected bills, prospects, plans and targets of administration are forward-looking statements. Examples of such statements embrace, however will not be 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 replicate administration’s present views with respect to sure present and future occasions and are topic to varied dangers, uncertainties and assumptions that would trigger the outcomes to vary materially from these anticipated by the administration of BiondVax Prescription drugs Ltd. Dangers and uncertainties embrace , however will not be restricted to, the chance of a delay in preclinical trials and the initiation of medical trials for NanoAbs, if any; the chance that the therapeutic and business potential of NanoAbs is not going to be met; the chance that preclinical or medical trials regarding NanoAbs will fail in complete or partly; the chance that the Firm will be unable to scale up its manufacturing processes;the chance that BiondVax might not have the ability to safe extra capital on engaging phrases, if in any respect; dangers regarding the COVID-19 (coronavirus) pandemic; BiondVax’s means to accumulate rights to extra product alternatives; BiondVax’s means 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 chance that the manufacturing facility will be unable for use for all kinds of functions and different vaccine and therapy applied sciences, and the chance that drug growth entails a prolonged and costly course of with unsure outcomes. Extra detailed details about the dangers and uncertainties affecting the Firm is contained underneath the heading “Threat Components” within the Firm’s Annual Report on Type 20-F filed with the Securities and Change Fee on March 28, 2022. BiondVax undertakes no obligation to revise or replace any forward-looking assertion for any purpose.




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