Sernova Corp. provided a development update on its exclusively licensed, proprietary conformal coating immune protection technology, being advanced in combination with the Cell Pouch? through a collaboration with Dr. Alice Tomei at the University of Miami, Miller School of Medicine.

The goal of the technology is to eliminate the need for long-term use of conventional immunosuppressive medications currently required to prevent graft rejection with Sernova's cell therapy program for treatment of type 1 diabetes (T1D). The conformal coating technology has been developed in partnership with Dr. Alice Tomei, Miami Engineering Career Development Associate Professor of Biomedical Engineering at the University of Miami and director of the Islet Immunoengineering Lab at the Miller School of Medicine Diabetes Research Institute. Dr. Tomei will provide a detailed update of the technology in a podium presentation at the 2023 IPITA-IXA-CTRMS Joint Congress being held in San Diego from October 26-29.

Presentation details will be shared in October 2023. These findings support approach and the potential to eliminate the need for the immunosuppressive cocktails that are typically used for islet transplant patients and are frequently associated with toxic side effects. As prerequisites for clinical testing in humans, characterization assays have been identified to develop and validate product release criteria for conformal coating.

Long-term in vitro stability and durability studies have been successfully completed and release testing is routinely conducted for the finished coated islet product to ensure quality, safety, and efficacy potential, prior to the transplantation of conformally coated islets into Cell Pouch. Sernova is also undertaking a standard array of biocompatibility studies and is completing an allogeneic optimization study using conformally coated islets in the Cell Pouch with the addition of a selective immune response agent which has proven effective in the ongoing Phase 1/2 clinical trial of the Cell Pouch System?? in T1D at the University of Chicago.

A single agent provided intermittently with the conformal coating technology would be a significant advancement in the field of cellular immune protection. Additionally, through a design and manufacturing partner, Sernova is developing a bench-top, scalable, fully automated, and GMP-compatible cell coating system. The clinical-scaled system is designed for installation in GMP cell manufacturing facilities that produce coated islets for clinical trials.

The conformal coating technology offers selective permeability, with immuno-protective capability, while not interfering with the kinetics of insulin and glucose release. Sernova is a clinical-stage biotechnology company that is developing therapeutic cell technologies for chronic diseases, including insulin-dependent diabetes, thyroid disease, and blood disorders that include hemophilia A. Sernova is currently focused on developing a 'functional cure' for insulin-dependent diabetes with its lead asset, the Cell Pouch System, a novel implantable and scalable medical device with immune protected therapeutic cells. On implantation, The Cell Pouch forms a natural vascularized tissue environment in the body for long-term survival and function of therapeutic cells that release essential factors.