LONDON, Ontario and WINDHAM COUNTY, Conn., Sept. 07, 2023 (GLOBE NEWSWIRE) — Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage company and leader in cell therapeutics, today 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 flagship cell therapy program for treatment of type 1 diabetes (T1D).
“One of the biggest challenges in bringing a ‘functional cure’ to people living with T1D is preventing therapeutic cell transplantation from eliciting an immune response without the need for conventional life-long immunosuppressive agents,” said Dr. Philip Toleikis, Chief Technology Officer of Sernova Corp. “Our conformal coating technology closely surrounds insulin-producing islets without altering the genetic makeup or function, offering potential protection from the human immune system while maintaining normal cell function. We are encouraged by both our ongoing preclinical results, and our continued progress with manufacturing scale-up of conformally coated islets, which is a key hurdle prior to initiation of clinical studies.”
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.
Dr. Tomei added, “I am pleased with the technical advancements we have made in collaboration with the Sernova scientific team. We have achieved success in pre-clinical safety and efficacy studies demonstrating the optimal conditions for conformally coated islets within the Cell Pouch. We have also made significant progress in developing release criteria which are essential for the clinical manufacturing process. Furthermore, along with Sernova, we have optimized the manufacturing process and are currently scaling up the GMP production of the conformally coated islets. These elements are critical to advancing the conformal coating technology into the clinic for the potential treatment of all patients with T1D. I look forward to sharing more on our progress at the 2023 IPITA-IXA-CTRMS Joint Congress in San Diego.”
Pre-clinical studies conducted at the University of Miami in collaboration with Sernova demonstrated that conformally coated islets transplanted into the pre-vascularized Cell Pouch achieved normal blood glucose control and reversed the effects of T1D in a syngeneic rat model of T1D. Conformally coated islets show normal responsiveness to glucose and fully regulated insulin production when transplanted in the Cell Pouch. Treated animals ultimately achieved full insulin independence (return to normal glucose levels).
In optimization studies in T1D animal models transplanted with conformally coated allogeneic islets in an implanted Cell Pouch, subjects treated with a single selective immune response agent achieved sustained, normalized blood glucose levels during the study period. These findings support our 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.
ABOUT THE CONFORMAL COATING TECHNOLOGY
The conformal coating technology is a proprietary, mechanically stable, thin, biocompatible, and cross-linked polymer hydrogel that coats the outside of each individual islet housed within the Cell Pouch. The conformal coating technology offers selective permeability, with immuno-protective capability, while not interfering with the kinetics of insulin and glucose release. Importantly, the conformal coating configuration also allows for the physiological transfer of oxygen and nutrients needed for islet survival and long-term function within the pre-vascularized Cell Pouch.
ABOUT SERNOVA CORP. AND THE CELL POUCH SYSTEM PLATFORM FOR CELL THERAPY
Sernova Corp. 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 that are absent or deficient in the bodies of patients with certain chronic diseases. Sernova’s Cell Pouch System has demonstrated its potential to be a ‘functional cure’ for people with T1D in an ongoing Phase 1/2 clinical study at the University of Chicago. Sernova is also advancing a proprietary technology in collaboration with the University of Miami to shield therapeutic cells from immune system attack with the goal to eliminate the need for chronic, systemic immunosuppression. In May 2022, Sernova and Evotec entered into a global strategic partnership to develop an implantable off-the-shelf iPSC (induced pluripotent stem cells) based islet replacement therapy. This partnership provides Sernova a potentially unlimited supply of insulin-producing cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova continues to progress two additional development programs that utilize its Cell Pouch System: a cell therapy for hypothyroid disease resulting from thyroid gland removal and an ex vivo lentiviral Factor VIII gene therapy for hemophilia A.
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