Scinai’s NanoAbs downregulated key molecular markers overexpressed in plaque psoriasis

Stratum corneum regained normal appearance in laboratory 3D skin model

Results from ex-vivo study in human psoriatic skin anticipated in Q4 2023; In-vivo animal study results anticipated in early 2024

JERUSALEM, Sept. 13, 2023 (GLOBE NEWSWIRE) -- via IBN – Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI) a biopharmaceutical company focused on developing, manufacturing, and commercializing innovative inflammation and immunology (I&I) biological products primarily for the treatment of autoimmune and infectious diseases, today announces encouraging results in a preclinical study of Scinai’s anti‑interleukin 17 (IL‑17) NanoAbs as a treatment for plaque psoriasis.

Scinai’s NanoAbs are alpaca‑derived recombinant variable domain of heavy-chain-only antibodies and are also known as nanobodies or VHH antibodies. The NanoAbs were tested in a 3D biologic skin model constructed out of a scaffold mounted with various skin cells to generate layers that mimic the structure of human skin and induced to express plaque psoriasis. Upon introduction of NanoAbs into the model (either topically or subcutaneously), standard molecular markers for psoriasis that are overexpressed in the disease (S100A7, CXCL1, and CCL20) were downregulated and outer skin layers (stratum corneum) regained normal appearance. These results suggest NanoAbs’ therapeutic potential to relieve symptoms of plaque psoriasis. In earlier laboratory tests the NanoAbs showed not only high affinity to all three IL-17 isoforms relevant for psoriasis (A, F and AF complex), but also significant neutralization of these isoforms in tissue cultures.

IL-17 plays a major role in the development of plaque psoriasis and is the molecular target of several recently launched biological treatments, mainly monoclonal antibodies (mAbs), such as Cosentyx (Novartis, NYSE: NVS) and Taltz (Lilly, NYSE: LLY), both of which target IL-17A. Research shows that targeting IL-17F isoform in addition to IL-17A provides higher efficacy in treating plaque psoriasis. The recently launched Bimzelx (UCB, Euronext Brussels: UCB) was the first mAb targeting both IL-17A and F to be approved by the by the European Medicines Agency (EMA). MoonLake Immunotherapeutics (Nasdaq: MLTX, Market Cap $3.1B) is also developing a 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 psoriasis patients, are administered by subcutaneous injection for systemic drug distribution and carry risk of considerable side effects. These drugs are also expensive as they require chronic, life long, bi-weekly injections, each at a cost of several thousand dollars. Mild psoriasis, which accounts for 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 tend to avoid or delay onset of these biological treatments due to the associated risks.

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.

The NanoAb, exclusively licensed to Scinai, was discovered by Professor Dirk Görlich, Director at the Max Planck Institute for Multidisciplinary Sciences and was tested for neutralization at the laboratory of Professor Matthias Dobbelstein at University Medical Center Göttingen (UMG). Görlich and Dobbelstein are Scinai’s lead collaborators for development of a pipeline of NanoAb-based inflammation and immunology (I&I) biological therapeutics for the treatment of autoimmune and infectious diseases such as psoriasis, psoriatic arthritis, asthma, wet AMD and COVID-19.

Scinai recently started to evaluate the anti-IL-17 NanoAbs in a full human skin model induced for plaque psoriasis to evaluate the effective dose and schedule of treatment, with in-vivo animal studies anticipated in early 2024.

About Scinai Immunotherapeutics Ltd.
Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI) is a biopharmaceutical company focused on developing, manufacturing and commercializing innovative inflammation and immunology (I&I) biological products primarily for the treatment of autoimmune and infectious diseases. With a state-of-the-art facility for biopharmaceutical product development and manufacturing and highly experienced pharmaceutical industry leadership, Scinai offers end-to-end boutique CDMO services in parallel to developing its own pipeline of diversified and commercially viable products and platforms beginning with an innovative nanosized VHH antibody (NanoAb) pipeline targeting diseases with large unmet medical needs. Company website: www.scinai.com.

Contact Details
Scinai: Joshua E. 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, statements regarding the timing of future preclinical studies and the therapeutic and commercial potential of NanoAbs. 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 a delay in results from ex-vivo study in human psoriatic skin and In-vivo animal study results; 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 that our business strategy may not be successful; the risk that the European Investment Bank (EIB) may accelerate the loans under its finance contract with Scinai; risks relating to the SARS-CoV-2 (COVID-19) virus; 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 on April 17, 2023. Scinai undertakes no obligation to revise or update any forward-looking statement for any reason.

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