Scinai Announces New Peer-Reviewed Publication Supporting PC111 as a Disease-Modifying Therapy for Pemphigus and SJS/TEN
Scinai Immunotherapeutics (NASDAQ:SCNI) announced a new peer-reviewed publication validating PC111, their first-in-class human anti-Fas Ligand monoclonal antibody, as a potential disease-modifying therapy for pemphigus and SJS/TEN. The research, published in the Journal of Dermatological Treatment, demonstrates PC111's ability to prevent blister formation across multiple study models.
The study confirms PC111's unique non-immunosuppressive mechanism, acting locally at the keratinocyte level. The treatment represents a market opportunity exceeding $1 billion annually. Scinai and Pincell plan to advance PC111 through IND-enabling studies, with potential market entry in 3-4 years. The program may receive up to 80% cost coverage through a €15 million FENG grant, pending Q3 2025 decision.
Scinai Immunotherapeutics (NASDAQ:SCNI) ha annunciato una nuova pubblicazione peer-reviewed che convalida PC111, il loro anticorpo monoclonale umano anti-Fas Ligand di prima classe, come potenziale terapia modificante la malattia per pemfigo e SJS/TEN. La ricerca, pubblicata sul Journal of Dermatological Treatment, dimostra la capacità di PC111 di prevenire la formazione di vesciche in diversi modelli di studio.
Lo studio conferma il meccanismo unico di PC111, non immunosoppressivo, che agisce localmente a livello dei cheratinociti. Il trattamento rappresenta una opportunità di mercato superiore a 1 miliardo di dollari all'anno. Scinai e Pincell prevedono di far progredire PC111 attraverso studi abilitanti IND, con un potenziale ingresso nel mercato entro 3-4 anni. Il programma potrebbe beneficiare di una copertura dei costi fino all'80% grazie a una sovvenzione FENG da 15 milioni di euro, in attesa della decisione nel terzo trimestre 2025.
Scinai Immunotherapeutics (NASDAQ:SCNI) anunció una nueva publicación revisada por pares que valida PC111, su anticuerpo monoclonal humano anti-Fas Ligand de primera clase, como una posible terapia modificadora de la enfermedad para el pénfigo y SJS/TEN. La investigación, publicada en el Journal of Dermatological Treatment, demuestra la capacidad de PC111 para prevenir la formación de ampollas en varios modelos de estudio.
El estudio confirma el mecanismo único no inmunosupresor de PC111, que actúa localmente a nivel de queratinocitos. El tratamiento representa una oportunidad de mercado superior a 1.000 millones de dólares anuales. Scinai y Pincell planean avanzar con PC111 mediante estudios habilitantes IND, con posible entrada al mercado en 3-4 años. El programa podría recibir hasta un 80% de cobertura de costos a través de una subvención FENG de 15 millones de euros, pendiente de decisión en el tercer trimestre de 2025.
Scinai Immunotherapeutics (NASDAQ:SCNI)는 그들의 최초의 인간 항-Fas 리간드 단클론 항체인 PC111을 천포창과 SJS/TEN에 대한 잠재적 질병 변형 치료제로 검증한 새로운 동료 검토 논문을 발표했습니다. 이 연구는 Journal of Dermatological Treatment에 게재되었으며, 여러 연구 모델에서 수포 형성을 예방하는 PC111의 능력을 입증합니다.
연구는 PC111의 독특한 비면역억제 메커니즘이 케라티노사이트 수준에서 국소적으로 작용함을 확인했습니다. 이 치료제는 연간 10억 달러 이상의 시장 기회를 나타냅니다. Scinai와 Pincell은 IND 승인 연구를 통해 PC111을 발전시킬 계획이며, 3-4년 내 시장 진입이 예상됩니다. 이 프로그램은 2025년 3분기 결정에 따라 1,500만 유로 FENG 보조금으로 최대 80% 비용 지원을 받을 수 있습니다.
Scinai Immunotherapeutics (NASDAQ:SCNI) a annoncé une nouvelle publication évaluée par des pairs validant PC111, leur premier anticorps monoclonal humain anti-Fas Ligand de sa catégorie, comme une thérapie potentielle modifiant la maladie pour le pemphigus et le SJS/TEN. La recherche, publiée dans le Journal of Dermatological Treatment, démontre la capacité de PC111 à prévenir la formation de cloques dans plusieurs modèles d'étude.
L'étude confirme le mécanisme unique non immunosuppresseur de PC111, agissant localement au niveau des kératinocytes. Ce traitement représente une opportunité de marché dépassant 1 milliard de dollars par an. Scinai et Pincell prévoient d'avancer PC111 à travers des études préparatoires IND, avec une entrée potentielle sur le marché dans 3 à 4 ans. Le programme pourrait bénéficier d'une prise en charge des coûts jusqu'à 80% grâce à une subvention FENG de 15 millions d'euros, décision attendue au troisième trimestre 2025.
Scinai Immunotherapeutics (NASDAQ:SCNI) gab eine neue peer-reviewed Veröffentlichung bekannt, die PC111, ihren erstklassigen humanen Anti-Fas-Ligand-Monoklonalantikörper, als potenzielle krankheitsmodifizierende Therapie für Pemphigus und SJS/TEN validiert. Die Forschung, veröffentlicht im Journal of Dermatological Treatment, zeigt die Fähigkeit von PC111, die Blasenbildung in mehreren Studienmodellen zu verhindern.
Die Studie bestätigt den einzigartigen nicht immunsuppressiven Wirkmechanismus von PC111, der lokal auf Keratinozyten-Ebene wirkt. Die Behandlung stellt eine Marktchance von über 1 Milliarde US-Dollar jährlich dar. Scinai und Pincell planen, PC111 durch IND-fähige Studien voranzutreiben, mit einem möglichen Markteintritt in 3-4 Jahren. Das Programm könnte bis zu 80% Kostenübernahme durch einen 15-Millionen-Euro-FENG-Zuschuss erhalten, vorbehaltlich einer Entscheidung im dritten Quartal 2025.
- PC111 demonstrated efficacy in preventing blister formation across in-vitro, ex-vivo, and in-vivo models
- Treatment offers unique non-immunosuppressive mode of action with potentially faster action and better safety profile
- Market opportunity exceeds $1 billion annually across both indications
- Potential 80% cost coverage through €15 million FENG grant
- Already received EU orphan drug designation
- Accelerated approval pathway could enable market entry within 3-4 years
- Final decision on €15 million FENG grant still pending
- Acquisition of Pincell by Scinai not yet finalized
- Program still in pre-clinical stage requiring significant development work
Insights
Scinai's PC111 shows promising disease-modifying potential for pemphigus and SJS/TEN through novel mechanism targeting Fas ligand.
The new peer-reviewed publication on PC111 represents a significant scientific validation for Scinai's lead candidate. What makes this data particularly compelling is the multi-model validation approach - demonstrating efficacy across in vitro, ex vivo, and now a proprietary humanized FasL mouse model, creating a comprehensive preclinical package.
The mechanism of action is notably differentiated from current standards of care. While existing treatments like steroids and Rituximab broadly suppress the immune system, PC111 targets soluble Fas Ligand (sFasL) specifically at the keratinocyte level. This downstream approach could potentially avoid systemic immunosuppression while addressing the actual cellular damage process in these conditions.
From a development perspective, PC111 has several favorable characteristics. The orphan drug designation in the EU (with US designation pending) provides regulatory advantages. Additionally, the data supporting both pemphigus and SJS/TEN indications expands the potential application to include a life-threatening condition, possibly enabling accelerated development pathways.
The existing competitive landscape further strengthens PC111's position, as the press release notes BTK and FcRn inhibitors have failed in late-stage development. With limited innovation in this space, a novel approach addressing the fundamental disease mechanism rather than just symptoms could significantly change treatment paradigms.
The potential
From a clinical perspective, what stands out most about PC111 is its potential to address a fundamental limitation in current pemphigus and SJS/TEN management. The non-immunosuppressive mechanism targeting Fas Ligand addresses the immediate tissue damage process rather than broadly dampening immune function. This distinction is crucial because current therapies create significant vulnerability to infections and other complications, limiting their long-term utility.
For pemphigus patients, treatment typically involves high-dose corticosteroids and rituximab, which can take months to achieve remission. During this period, patients experience continued blistering, pain, and risk of secondary infections. A therapy that could more rapidly control disease activity by directly preventing keratinocyte apoptosis would represent a paradigm shift.
The inclusion of SJS/TEN is particularly significant. This condition has a mortality rate of 25-30% even with optimal supportive care. Current management is limited to withdrawing the triggering agent (typically a medication) and providing intensive supportive care. No targeted therapies are approved. A treatment that could intervene in the massive keratinocyte death process could potentially save lives and reduce long-term complications like ocular damage.
The fact that PC111 demonstrates efficacy in preventing both skin and ocular damage in preclinical models is especially relevant for SJS/TEN, where ocular involvement occurs in 50-88% of patients and can lead to permanent blindness. This dual benefit could address a major unmet clinical need.
While promising, translation from preclinical models to human efficacy remains to be established. However, the comprehensive validation across multiple models and the clearly defined mechanism targeting a known pathological process provides a strong scientific rationale for clinical development.
New data builds on award-winning research and confirms efficacy and safety of PC111 across in-vitro, ex-vivo, and in-vivo humanized models
Authored by Dr. Roberta Lotti and colleagues from the University of Modena and Pincell Srl, the paper expands on Dr. Lotti's prior award-winning research that earned the "Oscar of Italian Dermatology" and was highlighted in Scinai's June 26 press release. The new publication "Treatment of pemphigus and other neglected skin conditions with PC111 a human anti-Fas Ligand monoclonal antibody: a potential disease modifier" confirms PC111's ability to prevent blister formation in in vitro, ex vivo, and in vivo humanized models of pemphigus by targeting soluble Fas Ligand (sFasL), a key effector of keratinocyte apoptosis and acantholysis.
Scientific and Translational Advancement
Building upon prior ex vivo studies, the research introduces new data from a proprietary humanized FasL mouse model, in which PC111 significantly reduced disease activity. Collectively, the data confirms PC111's unique, non-immunosuppressive mode of action: acting locally at the keratinocyte level and downstream of the immune system.
In addition to pemphigus, the authors highlight PC111's promise in SJS/TEN, a life-threatening dermatological emergency. Preclinical models show PC111 prevents FasL-mediated keratinocyte apoptosis and ocular damage, indicating potential for early intervention in this high-mortality condition.
Unmet Need and Market Potential
Current treatments for pemphigus and SJS/TEN rely on chronic, systemic immunosuppression. In pemphigus, this typically includes steroids and Rituximab, which are slow-acting and associated with serious side effects. Other approaches—including BTK and FcRn inhibitors—have failed in late-stage development.
By targeting the final step in disease pathology rather than suppressing the immune system, PC111 offers a differentiated, fast-acting, and safer therapeutic profile. Combined, the two indications represent an annual market opportunity exceeding
Development Path and Strategic Outlook
Subject to Scinai's exercise of its option to acquire Pincell, the two companies plan to advance PC111 through IND-enabling studies and into clinical development. PC111 has already been granted orphan drug designation in the EU, and a similar status will be pursued also in the
Risk-Mitigating Program Structure
Scinai and Pincell have embedded several strategic advantages into the PC111 program:
- Expert Leadership: The PC111 program is led by its inventor, Prof. Carlo Pincelli (CMO, Pincell), together with Dr. Antonino Amato (CEO, Pincell), Dr. Roberta Lotti (Senior Researcher and Project Manager), and Dr. Brydon Bennett (CSO, Pincell). They are supported by Scinai's Scientific Advisory Board, which includes Prof. Michael Schön and Dr. Jonathan Sadeh, both recognized leaders in dermatology and immunotherapy.
- Robust Evidence: PC111's efficacy is supported by multiple peer-reviewed publications, most notably the award-winning 2023 Frontiers in Immunology article and a new 2025 publication in the Journal of Dermatological Treatment.
- Non-Dilutive Funding: Pending a final decision expected in the third quarter of 2025, Scinai may receive up to
80% cost coverage through a€15 million FENG grant to support development through IND readiness. - Regulatory Strategy: The combination of orphan designation, high unmet medical need, and a well-defined mechanism of action supports a realistic path toward Breakthrough Therapy designation and/or Accelerated Approval.
CEO Statement
"This new publication further validates our conviction that PC111 has the potential to transform the treatment landscape for pemphigus and SJS/TEN," said Amir Reichman, CEO of Scinai. "The scientific leadership and development expertise of the Pincell's team have been instrumental, and with their expected integration into Scinai upon exercise of the option, we are well positioned to advance PC111. With strong science, regulatory clarity, and substantial market potential, we believe PC111 can deliver life-changing benefits to patients, and meaningful value to shareholders."
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; a delay in the market entry of Pincell; the risk that the annual addressable market of PC111 will be lower than anticipated; the risk that Scinai may be unable to remain compliant with the continued listing requirements of Nasdaq; 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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