JERUSALEM, Dec. 12,
2023 /PRNewswire/ -- Scinai Immunotherapeutics
Ltd. (Nasdaq: SCNI), a biopharmaceutical company focused on
development of inflammation and immunology biological products, is
pleased to announce today successful preclinical trial results of
its innovative anti–IL–17 VHH antibody ('NanoAb') as a local
treatment for the large and underserved population of mild to
moderate plaque psoriasis.
The study, conducted by Genoskin, a pioneering French
biotechnology company, aimed to evaluate the anti-inflammatory
effects of Scinai's NanoAbs. Genoskin's proprietary human skin
models were induced for expression of plaque psoriasis symptoms to
enable ex–vivo examination of the therapeutic effects of drugs
targeting underlying mechanisms in the pathogenesis of plaque
psoriasis, particularly the IL-17 family of pro-inflammatory
cytokines. 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. Genoskin's model has been successfully
validated[1] as a reliable ex-vivo system for
testing drugs aimed at plaque psoriasis.
The trial's study groups included intradermal injections in two
dosage schedules of Scinai's anti-IL-17 NanoAbs, which were
compared to Cosentyx® (a leading monoclonal anti-IL-17A antibody
treatment for severe psoriasis), Betamethasone (a topically applied
corticosteroid used a treatment for mild to moderate psoriasis), an
unrelated VHH NanoAb, and an untreated control. The
anti-inflammatory effect of Scinai's NanoAbs were evaluated by
measuring cytokine levels secreted by the skin tissues, including
IL-17 family cytokines. Additionally, the skin's structure,
integrity, and viability were assessed by a histological
analysis.
The statistically significant results demonstrated the potential
for Scinai's anti-IL-17 NanoAbs to noticeably improve psoriatic
skin lesions as indicated by skin viability and structural
integrity. This finding was corroborated by cytokine release
analysis, which showed significantly reduced IL-17 release
(p<0.001) as compared to the untreated control, similar to the
effects of Betamethasone and Cosentyx. These results were further
supported by histopathology results demonstrating improved skin
structure following a single dose, which appeared more efficient than
Betamethasone in reducing inflammation-induced skin and at least as
efficient as Cosentyx.
The results confirm and build upon previously reported
results indicating that Scinai's anti–IL–17 NanoAbs
downregulated key molecular markers overexpressed in plaque
psoriasis in a 3D scaffold of skin cells, a model mimicking a skin
tissue.
Dr. Tamar Ben-Yedidia,
Scinai's Chief Scientist, noted, "These positive results mark a
significant step forward in the development of a novel treatment
for the undertreated segment of mild and moderate plaque psoriatic
patients. To date, most of the innovation related to treatment of
autoimmune diseases focused on drugs aimed at the more severe cases
of these diseases, leaving milder cases 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 disease deterioration and worsening
of symptoms, mainly painful skin lesions. Scinai's vision is to
become the 'Botox-like solution', providing a highly efficacious,
specific, and safe biologic for local treatment of plaque psoriasis
lesions."
"I'd like to thank the Genoskin team for their professional
collaboration," continued Ben-Yedidia.
Scinai next intends to conduct an in-vivo proof of concept
animal study in early 2024 in collaboration with the prestigious
Technion Israel Institute of Technology complemented by a
pre-clinical toxicology study before commencing a first-in-human
clinical trial in late 2024. Scinai is excited about the
potential of its compounds and looks forward to further
advancements in this field.
About IL-17's role in Psoriasis:
IL-17 plays a major
role in the development of plaque psoriasis and is the molecular
target of several biological treatments, mainly monoclonal
antibodies (mAbs), which mostly target pro-inflammatory cytokines
or their receptors in the skin tissue. Cosentyx (Novartis) and
Taltz (Lilly), are examples of mAbs that target the cytokine IL-17
in its IL-17A isoform and are provided to patients with moderate to
severe psoriasis. Research shows that targeting the IL-17F isoform
in addition to IL-17A provides higher efficacy in treating plaque
psoriasis. The recently launched Bimzelx (UCB) was the first mAb
targeting both IL-17A and F to be approved by the European
Medicines Agency (EMA). MoonLake Immunotherapeutics is also
developing a VHH antibody (nanobody) targeting both IL-17A and F.
Last year, MoonLake reported superior results vs. Cosentyx in a
phase 2 plaque psoriasis clinical trial. All the above-mentioned
antibodies, indicated only for moderate to severe plaque psoriasis
patients, are administered by subcutaneous injection for systemic
drug distribution and carry the risk of considerable side effects.
These drugs are also expensive and require chronic, injections,
each at a cost of several thousand dollars. Mild psoriasis, which
accounts for more than 50% of plaque psoriatic patients,
unfortunately has no safe and affordable biological drug available.
Experience shows that even the 28% of patients with moderate plaque
psoriasis[2] tend to avoid or delay onset of these
biological treatments due to the associated risks and costs.
Conversely, Scinai's NanoAbs are designed to be administered
locally to the dermis and are engineered to degrade in a way that
should prevent systemic side effects. Results of this recent study
suggest the potential for a highly efficacious, specific, yet safer
and more convenient treatment for the large and underserved
population of mild to moderate plaque psoriasis patients.
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. These attributes sit at
the foundation of Scinai's strategy aimed at the milder yet
undertreated and underserved cases of autoimmune
diseases.
Scinai's NanoAb development pipeline includes anti-IL-17 NanoAbs
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 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.
Scinai has previously demonstrated the potential of its NanoAbs
as therapeutically viable molecules in COVID-19 animal studies.
These studies showed that the Company's inhaled COVID–19 NanoAb
therapy resulted in significantly milder and shorter illness,
virtually eliminated the virus from the lungs, and even protected
against illness when administered prophylactically. The studies
also demonstrated Scinai's ability to manufacture NanoAbs in-house
and to successfully deliver NanoAbs via inhalation, a difficult yet
desirable route-of-administration for antibody drugs.
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 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 Scinai Immunotherapeutics Ltd.
Risks and uncertainties include, but are not limited to, the
risk of delay in the NanoAb proof-of-concept studies and
clinical trial, 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, 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.
[1] Jardet et al. Development and characterization of a human
Th17-driven ex vivo skin inflammation model. Experimental
Dermatology. https://doi.org/10.1111/exd.14160
[2] Papp et al.
https://doi.org/10.1007/s13555-021-00518-8. Dermatology and
Therapy. https://doi.org/10.1007/s13555-021-00518-8
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SOURCE Scinai Immunotherapeutics Ltd.