Scientist testing

Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI), a biopharmaceutical company specializing in inflammation and immunology (I&I) biological products and in providing CDMO services through its Scinai Bioservices unit, proudly announces that Dr. Roberta Lotti, one of the lead scientists at Pincell Srl, has received the prestigious “Oscar of Italian Dermatology” from SIDeMaST, the Italian Society of Dermatology and Venereology. Dr. Lotti was recognized in the Immunopathology and Cutaneous Allergies category for her groundbreaking paper, “Blocking soluble Fas Ligand ameliorates pemphigus: PC111 efficacy in ex-vivo human pemphigus models.” The award-winning research centers on PC111, a first-in-class anti -Fas Ligand monoclonal antibody licensed by Scinai through its strategic option agreement to acquire the Italian biotech company Pincell srl.

PC111 is targeting the soluble form of Fas Ligand (sFasL) that has been shown to play a critical role in Pemphigus Vulgaris (PV), a rare and severe autoimmune blistering skin disease and Stevens-Johnson/Toxic Epidermal Necrolysis (SJS/TEN), a spectrum of severe drug reactions, generating an acute and rapidly progressing disease with cutaneous and mucosal manifestations associated with a high mortality rate.

Previous in vitro and in vivo studies conducted by Pincell demonstrated that soluble FasL induces keratinocyte apoptosis followed by acantholysis. The award-winning paper confirms the mechanism of action and the efficacy of PC111 in a human pemphigus context and demonstrated that PC111 blocks blister formation in an ex-vivo pemphigus model by inhibiting keratinocyte apoptosis, a central driver of disease pathology. By targeting the local effector mechanism downstream of the immune system, PC111 represents a novel, non-immunosuppressive approach that is both differentiated and disease-modifying — a significant advancement over current immunosuppressive treatments, which are associated with serious side effects due to their chronic systemic use.

This award not only recognizes the scientific excellence of Dr. Lotti’s publication, but also its clinical relevance and therapeutic innovation, highlighting PC111’s potential to shift the treatment paradigm from symptomatic relief to targeting the underlying immunopathogenic mechanism of pemphigus.

Dr. Antonino Amato, Chairman and CEO of Pincell, commented:

“This prestigious recognition from SIDeMaST is a proud moment for Pincell and a strong validation of our scientific approach. Dr. Lotti’s work, performed with the support of an international academic team, captures the essence of PC111’s differentiated mechanism and therapeutic promise. We are thrilled to partner with Scinai in carrying this program forward, with the vision and capabilities to bring it to patients in need.”

Amir Reichman, CEO of Scinai Immunotherapeutics, stated:

“We extend heartfelt congratulations to Dr. Lotti. Her award-winning research is a testament to the scientific rigor and innovative potential that underpins the PC111 program. This recognition reinforces the strategic merit of Scinai’s securing an option to acquire Pincell’s autoimmune dermatology pipeline and validates our conviction that PC111 has the potential to become a transformative, disease-modifying therapy. We are confident this program will deliver significant clinical value to patients and strategic value to our shareholders”.

The award was presented on June 18, 2025, during the XIV International Congress of Dermatology in Rome. SIDeMaST’s “Oscar of Italian Dermatology” is considered one of Italy’s most respected accolades in medical science, recognizing leading contributions across dermatology’s major therapeutic domains.

Scinai is advancing PC111 as one of its lead immunology assets, subject to Scinai’s exercise of its option, with development plans benefitting from orphan drug designation opportunities, the potential for accelerated approval, strong scientific rationale, and compelling preclinical efficacy/safety data. PC111’s non-immunosuppressive, local mechanism of action offers a highly attractive profile for a disease with limited safe and effective long-term therapies.

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