You are currently viewing Scinai Innovative Plaque Psoriasis Treatment Shows Encouraging Preclinical Results

Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI), a biopharmaceutical company (formerly Biondvax Pharmaceuticals Ltd) focused on developing, manufacturing, and commercializing innovative inflammation and immunology (I&I) biological products primarily for the treatment of autoimmune and infectious diseases, achieved encouraging results in a preclinical study of Scinai’s anti interleukin 17 (IL 17) NanoAbs as a treatment for plaque psoriasis. Plaque psoriasis is the most common type of psoriasis. It affects about 6.7 million adults. About 80% to 90% of people with psoriasis have plaque psoriasis. In addition to Plaque Psoriasis, Scinai is developing other VHH antibody (NanoAb) based drugs targeting autoimmune and infectious diseases, such as Asthma, COVID-19, Psoriatic Arthritis, and Wet AMD.

What are 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 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 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 the risk of considerable side effects. These drugs are also expensive as they require chronic, lifelong, 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 28% of patients with moderate plaque psoriasis tend to avoid or delay the 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.

Bio-better NanoAbs

Since recruiting Amir Reichman as the new CEO in March 2021, Scinai has established a robust collaboration with the prestigious Max Planck Society and the University Medical Center Göttingen (UMG), both in Germany, to develop a pipeline of novel NanoAbs. NanoAbs are alpaca (a small animal species similar to the Llamas) -derived recombinant variable domains of heavy-chain-only antibodies and are also known as nanobodies or VHH antibodies. By utilizing their unique attributes, Scinai’s NanoAbs are designed to overcome the limitations of existing antibody therapies to create “bio better” therapeutics that address large and underserved patient populations.

Scinai’s de-risked drug development approach significantly reduces the upfront time, cost, and risk of traditional new drug development, which generally involves the identification and validation of a novel molecular target, then screening for new drug candidates that will safely interact with the target to provide the desired therapeutic effect. This process can often take many years and cost hundreds of millions of dollars, yet nevertheless incurs a high rate of failure.

In contrast, Scinai’s bio-better drug development approach leverages well-understood molecular targets and mechanisms of action of commercially approved drugs (e.g., antibody neutralization), with NanoAbs designed to overcome current limitations of or risks associated with, the use of those commercially approved drugs. This bio-better strategy has been recognized as a valuable approach for smaller biotech companies, as recently demonstrated by the highly successful IPO of Apogee Therapeutics Inc. (NASDAQ: APGE, market cap ~$1.1 billion). Apogee’s monoclonal antibody programs, which are at a similar stage of development as Scinai’s NanoAbs, also target well-established molecular targets, incorporating advanced monoclonal antibody engineering to optimize properties such as their half-life.

While certain improvements in monoclonal antibodies can be helpful, Scinai believes that its NanoAbs, as designed by Prof. Dirk Görlich and his associates, 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. Görlich serves as Director of the Max Planck Institute for Multidisciplinary Sciences and was the 2022 recipient of the prestigious World Laureates Association (WLA) Prize in Life Science or Medicine.

Changing the Name – From BiondVax to Scinai Immunotherapeutics

BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biopharmaceutical company, changed its corporate name in September 2023 to Scinai Immunotherapeutics Ltd.. (“Scinai”). In the past two years, the Company has substantially revamped its senior management team and pharmaceuticals development programs and recently announced its expansion into the CDMO business under the banner Scinai Bioservices.

The new corporate name, which was approved by the Israeli authorities on August 31, is the Company’s latest step to better reflect its fresh start and new direction. Scinai and its new symbol, “SCNI”, debuted on Nasdaq on September 1st.

Scinai Immunotherapeutics Ltd. Closes $ 1.33 Million Registered Direct Offering

Scinai Immunotherapeutics Ltd. closed a registered direct offering of 1,146,552 of the Company’s American Depositary Shares (“ADSs”) (or ADS equivalents), each ADS representing four hundred (400) ordinary shares, at a purchase price of $1.16 per ADS (or ADS equivalent). In addition, in a concurrent private placement, Scinai has issued unregistered warrants to purchase up to 1,146,552 ADSs representing ordinary shares. The warrants have an exercise price of $1.16 per ADS and are immediately exercisable upon issuance for a period of five and one-half years.
H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

The gross proceeds to the Company from the offering are approximately $1.33 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. Scinai intends to use the net proceeds from the offering for general working capital, research and development, and general corporate purposes.

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:   Scinai Immunotherapeutics Ltd  www.scinai.com.

Contact Details: Joshua E. Phillipson | +972 8 930 2529 | joshua.phillipson AT scinai.com

 

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