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, recently
announced additional results in a preclinical in vivo
proof-of-concept study of its innovative inhaled nanosized antibody
(NanoAb) COVID-19 therapy, namely that the presence of the
SARS-COV-2 virus in the lungs of hamsters treated with BiondVax’s
NanoAb was below detectable levels and significantly (p<0.0005)
less than the amount of virus detected in the placebo group.
The first (experimental) group was treated with
BiondVax’s anti-COVID-19 NanoAb, administered via inhalation,
starting 24 hours after being infected, while the
second (control) group was treated in the same manner but with a
placebo. The study’s design is intended to mimic a real-world
situation in which treatment is provided well after, and not
simultaneously, to the moment of infections.
Six days after infection, compared to the
placebo group, hamsters treated with BiondVax’s inhaled NanoAb not
only had over 30 times lower SARS-COV-2 viral titers in their lungs
as measured by median tissue culture infectious dose (TCID50) but
also those levels were at the border of detection, suggesting
potential virtual elimination of the virus from their lungs. These
results were corroborated also by PCR.
As reported on Nov. 29, 2022, the efficacy of
BiondVax’s inhaled COVID-19 NanoAb is also supported by additional
data from the same study showing that compared to their weight
immediately prior to infection, the control group’s weight declined
on average 12.01%, while the weight of the experimental group,
which was administered BiondVax’s NanoAb through inhalation,
declined on average only 3.80%, a highly statistically significant
result (p<0.001). These successful results were further
supported by eight other tracked parameters, including heart rate
and social behaviors, that indicated the group treated with inhaled
NanoAbs experienced a milder and shorter illness.
Dr. Tamar Ben-Yedidia,
BiondVax’s Chief Science Officer (CSO), explained, “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,
stated, “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 study is using an industry-standard animal
model for COVID-19 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-COV-2, 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 continues in Jan. 2023 with additional arms testing lower
therapeutic doses and a prophylactic dose of the inhaled COVID-19
NanoAb. 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 pre‑clinical 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 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 proof-of-concept studies 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 clinical trials relating to NanoAbs will fail in
whole or in part; 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.
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