The webinar will explore PC111, a novel monoclonal antibody drug candidate with the potential to transform the treatment landscape for Pemphigus Vulgaris and Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN).
JERUSALEM, Israel, May 1, 2025 /PRNewswire/ -- Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI), a biopharmaceutical company specializing in inflammation and immunology (I&I) biological products and which provides CDMO services through its Scinai Bioservices unit, today announced that it will be hosting a webinar on Wednesday May 7th at, at 11:30 AM EST / 18:30 Israel time. The webinar will address the unmet needs in treating Pemphigus Vulgaris and Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN) and explore Pincell's PC111, a novel monoclonal antibody targeting soluble Fas ligand (sFasL) as a promising solution.
Join Scinai's Webinar: Exploring a Novel Antibody for Treating Rare Dermatological Diseases
The webinar will be broadcast via LinkedIn and YouTube. Interested participants can register using the following LINK.
On March 27 , 2025, Scinai announced that it had entered into a binding option agreement for the acquisition of the Italian biotech company Pincell srl. The parties have prepared a grant application, submitted on March 28th by the wholly owned Polish subsidiary of Scinai, seeking Euro 12 million of non-dilutive capital to fund the next stage of development of PC111. To facilitate the submission of the application, Pincell exclusively licensed PC111 to the subsidiary. The grant application is under the European Funds for a Modern Economy (FENG) program in Poland. An award decision is expected in Q3, 2025. Additional topics will include an introduction to Pemphigus Vulgaris and Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN) diseases, the current standard of care, and a review of the drug development plan for PC111 towards marketing authorization. The virtual panel discussion will feature:
Mr. Amir Reichman – CEO, Scinai Immunotherapeutics
Prof. Carlo Pincelli, MD – Co-founder & CMO, Pincell
Dr. Antonino Amato, MD – Chairman & CEO, Pincell
Dr. Jonathan Sadeh, MD – Scinai Advisory Board; CMO, Bausch Health R&D
Prof. Michael Schön, MD – Scinai Advisory Board; Dept. Head, Dermatology UMG
Participants will also have the opportunity to submit questions and receive answers during a Q&A session at the end of the webinar.
About PC111
PC111, a fully human, monoclonal antibody that binds to the human soluble Fas ligand (FasL) and thus blocks its activation of apoptosis of skin cells (keratinocytes). This pathway has a major role in several skin blistering disorders, characterized by a very high unmet medical need with significant market sizes. Importantly, PC111 does not suppress the immune system, at variance with many other biologicals treating inflammatory conditions that can lead to significant, at times fatal side effects.
Pincell has successfully developed a proprietary FasL humanized mouse model, with which it studied the involvement of the Fas/FasL pathway in these diseases, and that can be successfully used in other dermatological and non-dermatological diseases, where this pathway may play a key role in disease development and progression.
Pincell has carried out a large number of in-vitro, ex-vivo and in-vivo experiments using PC111 without steroids in validated models of pemphigus, to prove that soluble FasL is a critical target in this disease. Most importantly, Pincell has demonstrated that PC111 can block blister formation without steroids in a transgenic humanized FasL mouse model of pemphigus, indicating that the antibody can work also in a humanized setting and thus suggesting that it may be a novel targeted therapy for this disease at the clinical level. As there is abundant and convincing data supporting the critical role of soluble FasL also in the pathogenesis of SJS/TEN, PC111 could inhibit the mechanisms underlying the progression of this disease, as shown by the in vivo model where it ameliorates ocular conjunctivitis and edema, two main early features of this disease in humans, as well as its progression towards more severe forms.
About Pemphigus, Stevens-Johnson Syndrome, and Toxic Epidermal Necrolysis
Pemphigus, Stevens-Johnson Syndrome (SJS), and Toxic Epidermal Necrolysis (TEN) are severe dermatological conditions that significantly impact the skin and mucous membranes. Pemphigus is an autoimmune disorder characterized by painful blisters and sores, often requiring long-term immunosuppressive medications for disease management, which are associated with a 5-10% mortality. Stevens-Johnson Syndrome is a rare but serious reaction to medications or infections, with a mortality rate of around 5-10%. Toxic Epidermal Necrolysis, the most severe form of SJS, involves extensive skin peeling and blistering over more than 30% of the body surface, with mortality rates ranging from 30-40%. These conditions highlight a significant unmet medical need for more effective treatments and better management strategies to improve patient outcomes and reduce mortality rates.
About Pincell srl
PinCell is a biotechnology company targeting a novel pathological pathway to develop first-in-class anti-inflammatory therapies for the treatment of rare, severe and highly undertreated skin diseases. Based in Milan, Italy, PinCell was founded in October 2008 as an academic spin-off of the University of Modena and Reggio Emilia by the world class dermatology experts Prof. Carlo Pincelli and Prof. Alessandra Marconi. It has previously received seed funding from Sofinnova Partners to develop proof-of-concept data for its lead candidate PC111.
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 beginning with an innovative, de-risked pipeline of nanosized VHH antibodies (NanoAbs) targeting diseases with large unmet medical needs, and the other a boutique Biologics CDMO providing biological drug development, analytical methods development, clinical GMP manufacturing, and pre-clinical and clinical trial design and execution services to early stage biotech companies. Company website: www.scinai.com.
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, including statements relating to the exercise of the Binding Option Agreement and the grant application under the FENG program in Poland, 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 not exercise the Binding Option Agreement; that the sale and transfer of Pincell's shares will be delayed or not occur; that ownership of Pincell will not benefit Scinai as currently contemplated; that development of Pincell's antibody, PC111 will be delayed or not be successful; that the award decision for the grant application under the FENG program in Poland will be delayed or will not be approved; raise any capital under SEPA or that we will not otherwise benefit from the SEPA as currently anticipated; lower than anticipated revenues of Scinai's CDMO business; the risk that Scinai's expanded presence in the U.S. will not significantly enhance the prospects of its CDMO unit; the risk that the Company will otherwise 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 the contemplated in-vivo studies and a clinical trial; the risk that Scinai will not be successful in expanding its CDMO business or in-license 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 will not be met or that Scinai will not be successful in bringing the NanoAbs towards commercialization; the risk of a delay in the preclinical and clinical trials data for NanoAbs, 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 Jerusalem, if at all or when required; the risk that the manufacturing facility will not be able to be used for a wide variety of applications and other vaccine and treatment technologies; and the risk that drug development involves a lengthy and expensive process with uncertain outcomes. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission ("SEC") on May 15, 2024, and the Company's subsequent filings with the SEC. Scinai undertakes no obligation to revise or update any forward-looking statement for any reason.
