Scinai Immunotherapeutics’ PC111 featured in peer-reviewed publication

Scinai Immunotherapeutics (SCNI) announced the publication of a new peer-reviewed article in the Journal of Dermatological Treatment validating the disease-modifying potential of PC111, a first-in-class human anti-Fas Ligand monoclonal antibody. The new publication 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, a key effector of keratinocyte apoptosis and acantholysis. Collectively, the data confirms PC111’s 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. 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 $1B. 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 U.S. The two companies are exploring accelerated approval pathways that could allow market entry within approximately three to four years.Pending a final decision expected in Q3, Scinai may receive up to 80% cost coverage through a EUR15M FENG grant to support development through IND readiness.