SEOVF - Sernova Announces New Advancements of Conformal Coating Technology in Combination with the Cell Pouch System™ at the 2023 IPITA-IXA-CTRMS Joint Congress | Benzinga
LONDON, Ontario and WINDHAM COUNTY, Conn., Oct. 30, 2023 (GLOBE NEWSWIRE) -- Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage company and leader in cell therapeutics, today announced an update on its conformal coating immune protection technology program, that is used in combination with the Cell Pouch™. The goal of the program is to eliminate the need for chronic immunosuppression medications, currently used in islet cell transplantation for type 1 diabetes (T1D) treatment.
The update was presented by Dr. Alice Tomei, of the University of Miami, at the International Pancreas and Islet Transplant Association (IPITA)-International Xenotransplantation Association (IXA)-Cell Transplant and Regenerative Medicine Society (CTRMS) Joint Congress, taking place from October 26-29 in San Diego, California.
The presentation showcased positive advancement in the refinement of the coating composition and process, outcomes of preclinical studies with the Cell Pouch as well as rationale and historical development of the technology.
The following summarizes key advancements presented:
- The final conformal coating composition exhibits significantly improved cell compatibility and overall biocompatibility, representing evolution across years of process development work and preclinical testing.
- Coating process enhancements resulted in a 500% increase in conformal coating production capacity (number of starting islets to be coated) and an 89% overall islet encapsulation yield (ratio of conformal coated islets to initial islets). These enhancements have a direct positive impact on the in vitro and in vivo efficacy of the coated islets.
- The final conformal coated product was purified using a process to contain 98% conformal coated islets and only 2% empty capsules. This enables an increase in the number of functional coated islets that are transplanted within the Cell Pouch chambers and minimization of graft volume.
- Using these composition and process development improvements, the coated islets were tested, in combination with the Cell Pouch, in a syngeneic gold standard animal model of T1D to assess the safety and efficacy of the combined product.
- Biocompatibility of the coated islets within the Cell Pouch was confirmed histologically demonstrating healthy islets within the vascularized tissue matrix;
- Importantly, normal physiological transfer of glucose-stimulated insulin from the conformal coated islets within the Cell Pouch was confirmed;
- Diabetic animals that received conformal coated islets within the Cell Pouch exhibited controlled blood glucose to non-diabetic levels - which reversed upon removal of the Cell Pouch - proving function of the conformal coated islets.
- A series of pilot studies using conformal coated islets, in combination with the Cell Pouch, in an allogeneic rat model of T1D established the optimal conditions to achieve diabetes reversal. These conditions, which are being used in confirmatory allogeneic studies in additional upcoming preclinical work, included:
- Drug kinetic studies which identified the optimal dose and frequency of a single selective immune response agent to be used in combination with conformal coated islets;
- Islet dose-dependent glucose control was demonstrated using conformal coated islets in the Cell Pouch with the selective immune response agent.
- The release ...