Scinai Highlights Award-Winning Science Behind PC111 as Key Pincell Researcher Receives "Oscar of Italian Dermatology"
Rhea-AI Summary
Scinai Immunotherapeutics (NASDAQ:SCNI) announces that Dr. Roberta Lotti from Pincell Srl has received the prestigious "Oscar of Italian Dermatology" for her groundbreaking research on PC111, a first-in-class anti-Fas Ligand monoclonal antibody. The award recognizes Dr. Lotti's paper demonstrating PC111's efficacy in treating pemphigus through a novel, non-immunosuppressive approach.
PC111, which Scinai has rights to through a strategic option agreement to acquire Pincell srl, targets soluble Fas Ligand (sFasL) in Pemphigus Vulgaris (PV) and Stevens-Johnson/Toxic Epidermal Necrolysis (SJS/TEN). The research confirms that PC111 blocks blister formation by inhibiting keratinocyte apoptosis, representing a potential paradigm shift from current immunosuppressive treatments.
Positive
- PC111 demonstrates efficacy in treating pemphigus through a novel, non-immunosuppressive approach
- The drug has potential for orphan drug designation and accelerated approval pathway
- Strong scientific validation through prestigious award recognition
- Strategic option agreement provides Scinai rights to acquire Pincell's autoimmune dermatology pipeline
Negative
- None.
Insights
Award validates PC111's novel mechanism of action in autoimmune skin diseases, potentially supporting Scinai's acquisition strategy for Pincell.
Dr. Roberta Lotti's recognition with the "Oscar of Italian Dermatology" provides significant scientific validation for PC111, a first-in-class anti-Fas Ligand monoclonal antibody that Scinai has optioned through its agreement with Pincell. The award specifically acknowledges research demonstrating PC111's ability to block blister formation in pemphigus models by inhibiting keratinocyte apoptosis – the cellular death mechanism driving disease progression.
What makes PC111 particularly noteworthy is its novel, non-immunosuppressive approach to treating severe autoimmune skin conditions. Current treatments for Pemphigus Vulgaris (PV) and Stevens-Johnson/Toxic Epidermal Necrolysis (SJS/TEN) rely heavily on broad immunosuppression, which carries significant side effect burdens. PC111 instead targets the soluble form of Fas Ligand (sFasL), addressing the local effector mechanism without systemic immunosuppression.
This scientific recognition strengthens Scinai's strategic positioning in two important ways. First, it provides external validation of the mechanism behind their optioned asset. Second, it enhances the rationale for potentially exercising their option to acquire Pincell. The orphan disease focus suggests a streamlined regulatory pathway with opportunities for orphan drug designation and potentially accelerated approval processes.
From a clinical development perspective, PC111's differentiated mechanism targeting the underlying pathology rather than just symptoms positions it as potentially disease-modifying rather than merely palliative – a critical distinction in rare disease therapeutics where transformative treatments can command premium pricing and rapid market adoption despite small patient populations.
Dr. Roberta Lotti honoured for a pioneering work on PC111, reinforcing Scinai's 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
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.
About Scinai Immunotherapeutics
Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) is a biopharmaceutical company with two complementary business units, one focused on in-house development of inflammation and immunology (I&I) biological therapeutic products, starting with an innovative, de-risked pipeline of nanosized VHH antibodies (nanoAbs) targeting diseases with large unmet medical needs, and the other, a boutique CDMO providing biological drug development, analytical methods development, clinical cGMP manufacturing, and pre-clinical and clinical trial design and execution services for early-stage biotech drug development projects.
Company website: www.scinai.com
Company Contacts
Investor Relations - Allele Capital Partners | +1 978 857 5075 | aeriksen@allelecapital.com
Business Development | +972 8 930 2529 | bd@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, are forward-looking statements. 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 that Scinai will be unable to exercise its option to acquire Pincell, that Scinai may be required to resell its shares in Pincell to the previous shareholders under certain conditions, the risk that Scinai may be unable to remain compliant with the continued listing requirements of Nasdaq; lower than anticipated revenues of Scinai's CDMO business in 2025 and thereafter; failure to sign agreements with other potential clients of the CDMO business; a delay in the commencement and results of pre-clinical and clinical studies, including the Phase 1/2a study for psoriasis, the risk of delay in, Scinai's inability to conduct, or the unsuccessful results of, its research and development activities, including for PC111 or the contemplated in-vivo studies and a clinical trial; the risk that Scinai will not be successful in-licensing other nanoAbs; 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 or PC111 will not be met or that Scinai will not be successful in bringing the nanoAbs or PC111 towards commercialization; the risk of a delay in the preclinical and clinical trials data for nanoAbs or PC111, if any; the risk that our business strategy may not be successful; 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
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FAQ
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