Scinai’s IN-VIVO STUDY RESULTS
Scinai Immunotherapeutics Announced promising results in an in-vivo proof-of-concept psoriatic human skin model
Scinai BioServices business unit 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.
Scinai's novel anti IL-17A/F VHH antibody fragment shows potential as a local treatment for patients with mild to moderate plaque psoriasis, who often lack effective options.
“These results mark a significant step forward in addressing the needs of over 50% of psoriasis patients suffering unnecessarily”.
explains dr. Tamar Ben Yedidia, scinai’s csO .
Current treatments can be burdensome and have side effects, leading to low adherence rates. The study results revealed that Scinai’s NanoAb had a similar therapeutic effect to the two leading comparator drugs. This is an important achievement SINCE Scinai's product is not only intended to provide patients with a highly specific and convenient alternative with reduced risks for side effects but also comes with a low-frequency treatment schedule in comparison to the comparator drugs.
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.
“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.” noted Dr. Tamar Ben Yedidia, Scinai’s CSO
Scinai next intends to conduct a longer duration follow-up in-vivo animal study in late 2024, complemented by a pre-clinical toxicology study before commencing a first-in-human clinical trial in late 2025.
Please note that this information is based on preclinical results, and further studies are needed to confirm its effectiveness in humans.
[NanoAbs: Scinai’s NanoAbs are alpaca-derived recombinant variable domain of heavy-chain-only antibodies, also known as nanobodies or VHH antibodies.]
Expression of markers in skin xenografts:
IL-17 isoforms
IL-17A expression (red frame) Observed in the negative control Blocked by NanoAb and the other therapies
IL-17F expression (red frame) Observed in the negative control and in Secukinumab Blocked by NanoAb and the steroid treatment
