Data backs use of Scinai's aerosolized NanoAbs as a platform for
the treatment of hyperinflammatory viral diseases, addressing
significant medical needs
JERUSALEM, Dec. 11,
2023 /PRNewswire/ -- Scinai
Immunotherapeutics Ltd. (Nasdaq: SCNI), a biopharmaceutical
company focused on development of inflammation and immunology
(I&I) biological products, is pleased to announce the
publication following peer-review of an article titled
"Nanobodies to multiple spike variants and inhalation of
nanobody-containing aerosols neutralize SARS-CoV-2 in cell culture
and hamsters" in the prestigious scientific journal
Antiviral Research.
The article discusses a new generation of anti-SARS-CoV-2
NanoAbs, also known as nanobodies or VHH antibodies, developed in a
research collaboration between the Max Planck Institute for
Multidisciplinary Sciences (MPI-NAT), the University Medical Center
Göttingen (UMG), and Scinai Immunotherapeutics, and exclusively
licensed to Scinai. These NanoAbs are alpaca–derived recombinant
variable domain of heavy-chain-only antibodies.
The Antiviral Research paper covers several aspects of
the NanoAbs, including their structure, mechanism of action,
neutralization of a wide range of SARS-CoV-2 variants including
Omicron, production in yeast, and formulation into aerosols.
Moreover, the paper describes in vivo studies indicating that
"exposing hamsters to these aerosols, before or even 24 h
after infection with SARS-CoV-2, significantly reduced virus load,
weight loss and pathogenicity," concluding that these results show
the great potential of aerosolized NanoAbs for the prevention and
treatment of coronavirus infections.
Dr. Tamar
Ben-Yedidia, Scinai's Chief Scientist, is a
co-author of the paper together with Professor Dirk Görlich, Director at the MPI-NAT, Professor
Matthias Dobbelstein at UMG, and
others. Ben-Yedidia commented, "These results are a
striking proof-of-concept for the use of inhaled NanoAbs for the
treatment of hyperinflammatory respiratory viral diseases. We are
proud that our first NanoAb development project has been published
in the prestigious peer-reviewed scientific journal Antiviral
Research, as it validates our R&D strategy by clearly
demonstrating our NanoAbs' potential superiority to existing
therapies in several ways, including innate stability leading to
more convenient routes of administration such as inhalation. While
COVID-19 has dropped from the headlines, it continues to circulate
and cause illness. We strongly believe that convenient
self-administered treatments and prophylactics form the future of
respiratory viral disease pharmaceuticals, and the data in
this paper demonstrates the exciting potential of our NanoAbs to
fill this vital role. Indeed, we are currently actively marketing
this COVID-19 project for partnering with either pharma companies
or governmental health agencies."
"Our next pipeline project is an anti-IL-17 NanoAb for the
treatment of autoimmune diseases such as plaque psoriasis and
psoriasis arthritis. Recent preclinical results have been
promising, and I look forward to sharing more results soon,"
Ben-Yedidia concluded.
Amir Reichman, CEO of
Scinai, added "The publication of this prestigious journal article
comes at an auspicious time for our company. Scinai continues to
make great strides forward, consistent with our previously
announced plans. The publication validates the high level of
innovative science being conducted both by our partners and
in-house, as well as our decision to work with Max Planck and UMG to generate a pipeline of
these versatile relatively small molecule biologics. In addition,
Scinai Bioservices, our boutique CDMO business unit, now has
several customers, strong interest from other potential clients,
and financial support of the Israeli Innovation Authority via a
competitive grant as we announced last month."
The Antiviral Research paper is available online
at https://www.sciencedirect.com/science/article/pii/S0166354223002565.
It is currently undergoing copyediting and typesetting and will
soon be updated with the final version at this same link.
About Scinai's NanoAbs:
Scinai's NanoAbs are alpaca–derived recombinant variable domain
of heavy-chain-only antibodies and are also known as nanobodies or
VHH antibodies. The Company's pipeline of NanoAbs is being
discovered by and licensed out of the prestigious Max Planck
Society and the University Medical Center Göttingen (UMG), both in
Germany. By leveraging their
unique attributes, Scinai's NanoAbs are designed to overcome
limitations of existing antibody therapies to create therapeutics
that address large and underserved patient populations. Scinai
believes that its NanoAbs exhibit potential for several distinct
advantages over current leading monoclonal antibody treatments,
such as broader safety, effectiveness at very low doses, more
convenient routes of administration such as inhalation and
intra-dermal injection, and efficient manufacturing and supply
chain.
Scinai's development pipeline includes two fully licensed
NanoAbs, an anti-SARS-COV-2 NanoAb and an anti-IL-17 NanoAb for the
treatment of autoimmune diseases such as psoriasis, psoriatic
arthritis and Hidradenitis Suppurativa (HS). In addition, Scinai
holds a five-year research collaboration agreement with
Max Planck and UMG to discover and
characterize additional NanoAbs aimed at molecular targets such as
IL-13, IL-4, IL-4Ra and TSLP for the treatment of asthma and atopic
dermatitis and Ang-2 and VEGF for the treatment of age-related wet
macular degeneration. Scinai holds an exclusive option for an
exclusive license for each of the NanoAbs discovered through this
research collaboration. The pipeline approach affords Scinai
considerable flexibility with respect to partnering and spinning
out assets, opening enhanced potential to generate income through
license fees, milestone payments and royalties, in return for
participation in associated R&D costs.
About Scinai Immunotherapeutics:
Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI) is a
biopharmaceutical company with two complementary business units,
one focused on in-house development of inflammation and immunology
(I&I) biological products beginning with an innovative,
de-risked, pipeline of nanosized VHH antibodies (NanoAbs) targeting
diseases with large unmet medical needs, and the other a boutique
CDMO providing services to help biotech companies efficiently bring
their products to market by leveraging Scinai's drug development
and GMP and non-GMP manufacturing capabilities for pre-clinical and
clinical studies. Company website: www.scinai.com.
Company Contact
Joshua Phillipson | +972 8 930
2529 | joshua.phillipson@scinai.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 press release
regarding strategy, future operations, 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
effect of the article
titled "Nanobodies to multiple spike variants
and inhalation of nanobody-containing aerosols neutralize
SARS-CoV-2 in cell culture and hamsters" in the
scientific journal Antiviral Research. 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
Scinai Immunotherapeutics Ltd. Risks and
uncertainties include, but are not limited to, the risk that the
Company's financial health will not be positively impacted by the
amendment of the finance contract; the risk that the Company will
not remain listed on Nasdaq; the risk that the Company will not be
successful in becoming an end-to-end provider of CDMO
services at high international standards; the risk that
Scinai may not be able to secure additional capital on attractive
terms, if at all; the risk that the therapeutic and commercial
potential of NanoAbs will not be met; the risk of a delay in the
preclinical and clinical trials data for NanoAbs, if any; the risk
that our business strategy may not be successful; the risk that the
European Investment Bank (EIB) may accelerate the financial
facility under its finance contract with Scinai; Scinai's ability
to acquire rights to additional product opportunities; Scinai's
ability to enter into collaborations on terms acceptable to Scinai
or at all; timing of receipt of regulatory approval of Scinai'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 10-K filed with the Securities and Exchange
Commission ("SEC") on April 17, 2023,
and the Company's subsequent filings with the SEC. Scinai
undertakes no obligation to revise or update any forward-looking
statement for any reason.
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SOURCE Scinai Immunotherapeutics Ltd.