Two pre-clinical studies carried out by leading dermatologist Dr. Riichiro Abe, Professor and Chair of Dermatology at Niigata University, indicate that PC111 monoclonal antibody can ease Stevens-Johnson Syndrome by eliminating excess of circulating Fas ligand.
Severe form of SJS, called Toxic Epidermal Necrolysis, is often fatal and requires treatment in ICUs or burn units
MILAN, May 11, 2023 – PinCell, a biotechnology company developing a first-in-class therapy for rare and debilitating autoimmune skin diseases, announced today that two pre-clinical studies carried out in Japan by a specialized team indicate that its lead candidate, PC111, can be effective in treating Stevens-Johnson Syndrome (SJS), an acute skin disease with no approved therapy.
PC111 is a monoclonal antibody that can sharply reduce the over-expression of Fas ligand (FasL), implicated in pemphigus and other skin-blistering diseases.
Stevens-Johnson Syndrome is a rare and potentially life-threatening skin disease usually caused by a severe allergic reaction to medication or exposure to chemicals. Its most severe form (TEN, Toxic Epidermal Necrolysis), is an acute disease that is fatal in up to 30 percent of cases and requires that patients be placed in an intensive care or a burn unit. There currently is no approved drug for SJS/TEN; the current treatment focuses on
removing the cause, caring for wounds, controlling pain, and minimizing complications as skin regrows.
The latest studies were carried out by a team headed by Riichiro Abe, Professor and Chair of Dermatology at Niigata University, a reference center for SJS/TEN. The Japanese studies were carried out using human SJS patients’ blood samples, which were injected into immunocompromised mice, then exposed to the causative drug.
Two experiments were carried out, one in-vitro and one in-vivo. They showed that PC111 markedly reduced apoptosis of target cells and conjunctivitis (an early sign of SJS/TEN), thanks to its mode of action involving binding to the excess of Fas ligand, implicated in the origination and development of the disease. The conclusion reached was that PC111 prevents skin death and detachment associated with the elevated levels
of FasL, allowing for a potentially effective early therapeutic intervention.
“We are very thrilled about this additional evidence and ready to enter into IND enabling studies, with a view to starting studies with PC111 in SJS/TEN and pemphigus patients in about 18 months” said Dr. Tony Amato, CEO of PinCell. “We are confident that PC111 has the potential to be on an accelerated approval path, so that patients suffering from these rare and underserved diseases can benefit from it in the shortest possible
“We have high hopes that this antibody will keep future SJS/TEN patients out of intensive care and help them heal quickly,” said Prof. Carlo Pincelli, CMO of the company, adding that “high FasL levels are associated with a number of other dermatological and non-dermatological diseases where PC111 can be very useful.”
PinCell is a biotechnology company targeting a novel pathological pathway to develop first-inclass 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 spinoff of the University of Modena and Reggio Emilia by the world-class dermatology experts Prof. Carlo Pincelli and Prof. Alessandra Marconi. PinCell received seed funding from Sofinnova Partners.
For more information, please visit: www.pincell.it
About Sofinnova Partners
Sofinnova Partners is a leading European venture capital firm in life sciences, specializing in healthcare and sustainability. Based in Paris, London and Milan, the firm brings together a team of professionals from all over the world with strong scientific, medical and business expertise. Sofinnova Partners is a hands-on company builder across the entire value chain of life sciences investments, from seed to later-stage. The firm actively partners with ambitious entrepreneurs as a lead or cornerstone investor to develop transformative innovations that have the potential to positively impact our collective future.
Founded in 1972, Sofinnova Partners is a deeply established venture capital firm in Europe, with 50 years of experience backing over 500 companies and creating market leaders around the globe. Today, Sofinnova Partners has over €2.5 billion under management.
For more information, please visit: sofinnovapartners.com
Tony Amato, MD