Scinai Immunotherapeutics Ltd., a biopharmaceutical company specializing in inflammation and immunology (I&I) biological products and in providing CDMO services through its Scinai Bioservices unit, announced that it has entered into a binding option agreement for the acquisition of the Italian biotech company Pincell srl.
In anticipation of the signing of the option agreement, the parties have prepared together a grant application, submitted today 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. Subject to prior clearance of certain Italian regulatory formalities, an award decision is expected by mid-July/beginning of August.
About PC111
PC111, a fully human, monoclonal antibody that binds to the human soluble Fas ligand 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.