via InvestorWire –
BiondVax Pharmaceuticals Ltd.
(Nasdaq: BVXV), a biotechnology company focused on
developing, manufacturing and commercializing innovative
immunotherapeutic products primarily for the treatment of
infectious and autoimmune diseases, today announced additional
results in a preclinical proof-of-concept study of its innovative
inhaled NanoAb COVID-19 drug. Using an industry-standard animal
model, the study compared weight loss in two groups of hamsters.
Hamsters administered a mid-sized 0.66mg dose of the NanoAb
three hours prior to infection experienced no
significant weight loss over the six-day trial, whereas the
untreated control group’s weight declined 12% on average, a highly
statistically significant difference (p<0.0005).
The study’s design is intended to mimic a
real-world situation in which at-risk groups, such as the elderly,
people with comorbidities, the immunocompromised, travelers, those
attending densely packed social situations such as weddings,
sporting events and flights, and front-line health care
professionals, may proactively protect themselves ahead of
potential exposure to SARS-CoV-2 using BiondVax’s self‑administered
inhaled NanoAb therapy.
These promising prophylactic results follow
previously reported data from the same study indicating that
compared to the control (placebo) group, hamsters treated with a
2mg dose of 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 at
least 30-times higher viral titers in their lungs at the end of the
trial. Furthermore, and being reported here for the first time,
lung histopathology revealed that therapeutic inhalation of NanoAbs
reduced damage to alveoli, pulmonary vessels, and the conductive
system.
“We continue to be thrilled with the results of
this ongoing trial,” stated Amir Reichman,
BiondVax’s CEO. “There is strong market demand for COVID
prophylactics as evidenced by AstraZeneca’s reported Q1 through Q3
2022 EVUSHELD revenues of $1.5 billion1. EVUSHELD is currently the
only prophylactic COVID medication with FDA approval, under
emergency use authorization. Our inhaled NanoAb is designed to be
self-administered at the time of choosing to generate rapid
protection from COVID illness. In contrast, EVUSHELD must be
administered via two separate consecutive intramuscular (IM)
injections in a health care setting, and the FDA has confirmed it
does not effectively neutralize recent Omicron variants of
concern.2”
“Data from our trial indicate that our NanoAb
may effectively serve as both a therapeutic and protective
prophylactic drug, which further enhances its value proposition.
COVID vaccine uptake is declining, effectiveness wanes over a short
period of time, and vaccination campaigns demand vast health care
system resources. The way forward must include effective
prophylactic and therapeutic drugs. We believe the additional
‘biobetter’ value provided by our NanoAb potentially positions it
to capture significant market share both for treatment and
prevention of COVID illness,” Mr. Reichman
concluded.
BiondVax’s Chief Science Officer (CSO)
Dr. Tamar Ben-Yedidia explained, “We anticipate
that our convenient self-administered inhaled NanoAbs will be
highly attractive to at-risk people wishing to proactively,
effectively, conveniently, and safely protect themselves. This
builds on the trial’s exciting data indicating that our NanoAbs can
also treat COVID illness after infection. We look forward to
completing this preclinical trial and moving towards a
first-in-human Phase 1/2a clinical trial later this year.”
The study is using an industry-standard animal
model for COVID-19 prophylactics, therapeutics, and vaccines.
Weight loss is the key parameter for assessing disease severity in
hamsters used as experimental animals in development of
therapeutics and vaccines for COVID-19 disease. As noted 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 noted that weight loss in hamsters was
reduced when treated with REGN-COV2, a human mAb combination
therapy that ultimately received FDA approval for SARS-CoV-2
treatment. A similar model was also used by Pfizer when developing
Paxlovid, as noted in the paper titled The oral protease inhibitor
(PF-07321332) protects Syrian hamsters against infection with
SARS-CoV-2 variants of concern.
The study is being conducted by two
world-renowned institutions: The Fraunhofer Institute for
Toxicology and Experimental Medicine (ITEM) and The University of
Veterinary Medicine Hannover (TiHo), Germany.
Next steps: This preclinical
trial is continuing with additional arms testing lower therapeutic
doses (0.66mg and 0.22mg). The study will also evaluate safety
parameters. Results of the dosing study will inform the design of
future studies of BiondVax’s anti‑COVID‑19 inhaled NanoAb.
Specifically, in 2023, BiondVax is expected to conduct a
preclinical toxicity study to assess safety as required by
regulatory authorities for approval of human clinical trials. The
Company is also expected to scale up its manufacturing processes to
produce, at its GMP manufacturing site in Jerusalem, the NanoAbs
for the first-in-human Phase 1/2a clinical trial, which is planned
for Q4 2023.
NanoAb as mAb biobetter: As
part of a strategic research collaboration with the Max Planck
Institute for Multidisciplinary Sciences and the University Medical
Center Göttingen, BiondVax is developing a pipeline of innovative
alpaca‑derived nanosized VHH-antibody (NanoAb) therapies addressing
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), NanoAbs exhibit the potential to capture significant market
share as biobetters. In particular, as reported by Pfizer, Paxlovid
has shown the demand for COVID-19 therapeutic treatments with ~$22
billion in sales projected for the year ended Dec. 31, 2022, even
with significant limitations of use due to adverse cross-reactions
with other drugs and several other comorbidity contraindications
that limit its use. In contrast, NanoAbs exhibit strong potential
for superior patient convenience, safety, and clinical outcomes, at
lower costs. For example, as demonstrated by this preclinical
study, BiondVax’s NanoAb is efficacious when administered through
inhalation rather than by injection as with currently available
COVID-19 mAb therapies. In addition, most of the currently approved
mAbs for the treatment of COVID-19 are not sufficiently efficacious
against the Omicron variants of concern (VoCs) while BiondVax’s
lead drug candidate demonstrated strong neutralization of all
SARS-CoV-2 VoCs from Wuhan through Omicron, including the recent
BA4/5 and BQ1 sub-variants.
About BiondVaxBiondVax
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 its inception,
BiondVax has executed eight clinical trials including a
seven-country, 12,400-participant Phase 3 trial of its prior
vaccine candidate and has built a state-of-the-art manufacturing
facility for biopharmaceutical products. 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 nanosized antibody (NanoAb)
pipeline. www.biondvax.com.
Contact DetailsInvestor 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 facts, included in
this communication regarding strategy, future operations, future
financings, future financial position, future revenue, projected
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 with respect to
certain current and future events and are subject to various risks,
uncertainties and assumptions that could cause the results to
differ materially from those expected by the management of BiondVax
Pharmaceuticals Ltd. Risks and uncertainties include, but are not
limited to, the risk of a delay in preclinical trials and the
commencement of clinical trials for NanoAbs, if any; the risk that
the therapeutic and commercial potential of NanoAbs will not be
met; the risk that preclinical or clinical trials relating to
NanoAbs will fail in whole or in part; the risk that the Company
will not be able to scale up its manufacturing processes; the risk
that BiondVax may not be able to secure additional capital on
attractive terms, if at all; risks relating to the COVID-19
(coronavirus) pandemic; BiondVax’s ability to acquire rights to
additional product opportunities; BiondVax’s ability to enter into
collaborations on terms acceptable to BiondVax or at all; timing of
receipt of regulatory approval of BiondVax’s manufacturing facility
in Jerusalem, if at all or when required; the risk that the
manufacturing facility will not be able to 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 contained 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 undertakes no obligation to
revise or update any forward-looking statement for any reason.
###
1
https://www.astrazeneca.com/media-centre/press-releases/2022/year-to-date-and-q3-2022-results.html
2
https://www.fda.gov/drugs/drug-safety-and-availability/fda-releases-important-information-about-risk-covid-19-due-certain-variants-not-neutralized-evusheld
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