Scinai Immunotherapeutics announces results from preclinical NanoAbs study

Scinai Immunotherapeutics (SCNI) announced results in a preclinical study of Scinai’s anti-interleukin 17, or 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, standard molecular markers for psoriasis that are overexpressed in the disease were downregulated and outer skin layers 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, 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, or mAbs, such as Cosentyx (NVS) and Taltz (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 was the first mAb targeting both IL-17A and F to be approved by the by the European Medicines Agency, or EMA. MoonLake Immunotherapeutics (MLTX) 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 Gorlich, 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 Gottingen (UMG). Gorlich and Dobbelstein are Scinai’s lead collaborators for development of a pipeline of NanoAb-based inflammation and immunology 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.