Sernova Announces New Advancements of Conformal Coating Technology in Combination with the Cell Pouch System™ at the 2023 IPITA-IXA-CTRMS Joint Congress

Rhea-AI Summary

Sernova Corp. announced an update on its conformal coating immune protection technology program, aiming to eliminate the need for chronic immunosuppression medications in islet cell transplantation for type 1 diabetes treatment. The update presented positive advancements in coating composition and process, including a 500% increase in production capacity and an 89% encapsulation yield. The final product contained 98% coated islets and demonstrated biocompatibility and glucose-stimulated insulin transfer. Pilot studies established optimal conditions for diabetes reversal, and release criteria for clinical manufacturing have been developed. Manufacturing of coating scale-up equipment is in progress.

Positive

• The final conformal coating composition exhibits significantly improved cell compatibility and overall biocompatibility.
• Coating process enhancements resulted in a 500% increase in conformal coating production capacity and an 89% overall islet encapsulation yield.
• The final conformal coated product was purified to contain 98% conformal coated islets and only 2% empty capsules.
• The coated islets, in combination with the Cell Pouch, demonstrated controlled blood glucose to non-diabetic levels in a syngeneic animal model of T1D.
• Optimal conditions for diabetes reversal were established in pilot studies using conformal coated islets in an allogeneic rat model of T1D.
• Release criteria essential for clinical manufacturing have been developed, ensuring long-term function of the conformal coating technology in vivo.
• Significant progress was achieved in manufacturing the coating scale-up equipment.

Negative

• None.

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 criteria essential for clinical manufacturing have been developed, including coating conformality, completeness, stiffness, thickness, and selective permeability. Using these criteria, the conformal coating material showed long term mechanical stability, durability and selective permeability to insulin and glucose molecules but not to antibodies or inflammatory cells. These are key requirements for long-term function of the conformal coating technology in vivo.
  
• Significant progress was achieved in manufacturing of the coating scale up equipment. Prototype devices are manufactured, and testing is in progress. Final system design will provide fully automated, GMP-compliant coating applied to transplantable coated islets. The system function will involve conformal coating, washing, counting and production monitoring.
  

“We have made significant advancements in the evolution of the conformal coating technology in our collaboration with Sernova and are confident we have the final formulation. I look forward to our continuing studies and presenting more results,” said 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.

“We understand that eliminating the standard immune suppression regimen is key to Sernova delivering a ‘functional cure’ for all T1D patients,” said Cynthia Pussinen, Chief Executive Officer at Sernova. “Our goal is to continue to drive this technology ahead and ultimately bring a local immune-protected cell product into the clinic combined with the Sernova Cell Pouch and iPSC islet-like clusters.”

RELEVANT PRESENTATION DETAILS

Title: Transplantation of Conformal Coated Islets in a Pre-Vascularized Cell Pouch™ Device for Beta Cell Replacement in Diabetic Rats

Session: Islet Transplantation: Engineering the Islet Site Session

Date: Friday, October 27, 2023

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.

FOR FURTHER INFORMATION, PLEASE CONTACT:

Corporate:	Investors:	Media:
Christopher Barnes VP, Investor Relations Sernova Corp. christopher.barnes@sernova.com Tel: 519-902-7923 www.sernova.com	Corey Davis, Ph.D. LifeSci Advisors, LLC cdavis@lifesciadvisors.com Tel: 212-915-2577	Hannah Holmquist LifeSci Communications hholmquist@lifescicomms.com Tel: 619-723-4326

FORWARD-LOOKING INFORMATION

This release contains statements that, to the extent they are not recitations of historical facts, may constitute “forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but not always, words such as “expects”, “plans”, “anticipates”, “believes”, “intends”, “estimates”, “projects”, “potential for” and similar expressions, or that events or conditions “will”, “would”, “may”, “could” or “should” occur are used to identify forward-looking statements. These statements reflect management’s beliefs with respect to future events and are based on information currently available to management on the date such statements were made. Many factors could cause Sernova’s actual results, performances or achievements to not be as anticipated, estimated or intended or to differ materially from those expressed or implied by the forward-looking statements contained in this news release. Such factors could include, but are not limited to, the company’s ability to secure additional financing and licensing arrangements on reasonable terms, or at all; ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch System and or related technologies, including the timing and results of those trials; ability to obtain all necessary regulatory approvals, or on a timely basis; ability to in-license additional complementary technologies; ability to execute its business strategy and successfully compete in the market; and the inherent risks associated with the development of biotechnology combination products generally. Many of the factors are beyond our control, including those caused by, related to, or impacted by the novel coronavirus pandemic. Investors should consult the company’s quarterly and annual filings available on www.sedarplus.ca for additional information on risks and uncertainties relating to the forward-looking statements. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

FAQ

What is the goal of Sernova Corp.'s conformal coating immune protection technology program?

The goal is to eliminate the need for chronic immunosuppression medications in islet cell transplantation for type 1 diabetes treatment.

What were the key advancements presented in the update?

The advancements include improved cell compatibility and overall biocompatibility of the conformal coating composition, a 500% increase in production capacity, and an 89% encapsulation yield.

What are the benefits of the final conformal coated product?

The final product contains 98% conformal coated islets, demonstrating biocompatibility and glucose-stimulated insulin transfer.

What were the results of the pilot studies using conformal coated islets?

The studies established optimal conditions for diabetes reversal in an allogeneic rat model of T1D.

What progress was made in manufacturing the coating scale-up equipment?

Significant progress was achieved, with prototype devices manufactured and testing in progress.