JERUSALEM, July 15,
2024 /PRNewswire/ -- Scinai Immunotherapeutics
Ltd. (Nasdaq: SCNI) (the "Company"), a biotechnology
company focused on developing inflammation and immunology (I&I)
biological products and on providing CDMO services through its
Scinai Bioservices business unit, today announced successful
in-vivo preclinical study results of its innovative anti IL-17A/F
VHH antibody fragment ('NanoAb') as a local, first of its kind,
intralesional biological treatment for the large and underserved
population of patients suffering from mild to moderate plaque
psoriasis.
The Market Need
Today, there are about 13 million patients
diagnosed with plaque psoriasis in the 7 major markets (US, EU5 and
Japan). 50% of all psoriasis
patients suffer from mild disease and about 28% suffer from
moderate psoriasis1. Patients diagnosed with mild to
moderate plaque psoriasis often suffer from considerable and
visible lesions which may be uncomfortable, painful, and have a
negative impact on their social and mental well-being, especially
when the lesions are located on the face, genitals, scalp, palms of
hands, and bottom of feet. The therapeutics for mild to moderate
plaque psoriasis include mostly corticosteroids, applied topically,
and phototherapy. These treatments require very frequent use, have
risks for local adverse effects such as skin atrophy and
development of tolerance, and suffer from low patient adherence to
treatment schedule. The current therapeutics for moderate to severe
disease include mostly biologics and JAK inhibitors. While highly
efficacious, these treatments are administered systemically, are
highly expensive and require chronic use, which carries long term
health risks and considerable economic burden to the patients and
the health care system. Therefore, treatment of mild to moderate
plaque psoriasis is suboptimal and can be improved.
Scinai's product candidate is designed to address
the major shortcomings of currently available treatments. It is a
biologic, intended to be delivered locally, intradermally,
into the psoriatic lesions using a very short and almost painless
needle. Scinai's product is designed to allow patients with mild to
moderate psoriasis to benefit from a low frequency treatment that
comes with the high specificity and potency saved for biologics but
with significantly reduced risk of local side effects associated
with corticosteroids or systemic side effects associated with
systemic administration of biologics.
The Study
The study was conducted by the team of Prof. Amos Gilhar, a
leading researcher and dermatologist who heads the internationally
renowned Skin Research Laboratory at the Technion, Israel Institute
of Technology, Haifa. The study
aimed to demonstrate that local, intralesional treatment with
Scinai's NanoAb, which targets the two isoforms of the cytokine
IL-17 (A and F) implicated in plaque psoriasis, has at least a
non-inferior anti-inflammatory effect on the psoriatic lesions
compared to corticosteroids and systemic biologics.
For this purpose, human skin was transplanted onto the back of
SCID-Beige mice and psoriasis was induced by injection of activated
human peripheral blood mononuclear cells (PBMCs) from patients
diagnosed with psoriasis. This disease-induced skin model
reproduces key features of plaque psoriasis tissue morphology as
well as the cytokine profile associated with the inflammatory state
of plaque psoriasis lesions. The mice were divided into study
groups with each group treated for two weeks. The therapeutic
effect was then evaluated for three additional weeks, post the last
treatment.
The trial's study groups included Scinai's anti-IL-17
NanoAbs, two comparator approved drugs (Betamethasone, a topically
applied corticosteroid used for the treatment of patients with mild
to moderate psoriasis and Secukinumab, a leading monoclonal
anti-IL-17A antibody approved for systemic administration for the
treatment of patients with moderate to severe psoriasis), and an
unrelated VHH NanoAb used as negative control. The
anti-inflammatory effect of Scinai's NanoAbs was evaluated by
measuring cytokine levels secreted by the skin tissues, including
their direct target IL-17 A/F cytokines together with other
inflammatory markers such as TNFa, Psoriasin, HBD-2, IL-22, CD31,
HLA-DR and lymphocytes markers CD4 and CD8. Additionally, the
skin's structure, integrity, and viability were assessed by a
histopathological analysis.
The unique ability of Scinai's NanoAb to neutralize both IL-17A
and IL-17F isoforms was confirmed, this time in-vivo, by the
histopathology analysis, which demonstrated that Scinai's NanoAb
led to reduced levels of both IL-17 isoforms in the psoriatic skin
tissue.
In addition, the statistical analysis of these markers confirmed
that the effect of Scinai's NanoAb on the tested inflammatory
markers was similar to that of the two comparator drugs, supporting
the hypothesis that intralesional injection of a nanoAb blocking
the IL-17 cytokine can impact the inflammatory cytokine cascade,
and lead to reduction in psoriatic lesion severity and improvement
of the skin's integrity.
The results confirm and build upon previous reported results
from ex-vivo studies done with human skin specimens (conducted by
Genoskin) and in a plaque psoriasis in vitro model with human skin
tissue grown in a dish.
Dr. Tamar Ben-Yedidia, Scinai's
Chief Scientist, noted, "These positive results are very
encouraging and mark a significant step forward in the development
of a novel treatment for the underserved needs of the mild to
moderate plaque psoriatic patients. To date, most of the innovation
related to treatment of autoimmune diseases has focused on drugs
aimed at the more severe cases of these diseases, leaving milder
cases mostly with generic topical drugs and phototherapy
treatments. The mild psoriatic patients account for more than 50%
of the plaque psoriatic patients and while undertreated they are
prone to painful skin lesions sometimes in locations that generate
a considerable disease burden for them. Scinai's vision is to
provide a highly efficacious, specific, convenient and safe local
biologic treatment of plaque psoriasis lesions."
"I'd like to thank Prof. Amos Gilhar and his team for their
collaboration and excellence," continued Ben-Yedidia.
Scinai next intends to further fine tune dosing and drug
half-life and conduct a longer duration follow on in-vivo animal
study in late 2024, again, in collaboration with Prof. Gilhar of
the Technion Israel Institute of Technology, complemented by a
pre-clinical toxicology study before commencing a first-in-human
clinical trial in late 2025.
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 therapeutic 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 biological drug development,
analytical methods development, clinical cGMP manufacturing, and
pre-clinical and clinical trial design and execution services to
early stage biotech drug development programs.
Company Contacts
Investor Relations | +972 8 930 2529 | ir@scinai.com
Business Development | +972 8 930 2529 | bd@scinai.com
Website: www.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, are forward-looking statements.
Examples of such statements include, but are not limited to, the
timing of pre-clinical 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 Scinai
Immunotherapeutics Ltd. Risks and uncertainties include, but are
not limited to, the risk that Scinai will not conduct a follow on
in-vivo animal study in late 2024, complemented by a pre-clinical
toxicology study, will not conduct an in-human clinical trial, or
that such studies and trial will be delayed; that; the risk of
delay in, Scinai's inability to conduct, or the unsuccessful
results of, its research and development activities, including the
contemplated in-vivo studies and a clinical trial; the risk that
Scinai will not be successful in expanding its CDMO business or
in-license other NanoAbs; 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 or that Scinai will not be successful in bringing the
NanoAbs towards commercialization; 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; the risk that the
Company will not execute a definitive agreement with the EIB
providing for revised terms of the Finance Contract with EIB; the
risk that execution of such a definitive agreement will not resolve
the deficiency notice of Nasdaq with respect to the Company's
shareholders' equity; the risk that the Company will otherwise be
unable to regain compliance and remain compliant with the continued
listing requirements of Nasdaq; 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 20-F filed with the Securities and
Exchange Commission ("SEC") on May 15,
2024, 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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