Press release Communiqué de presse
Press release Communiqué de presse
October 30, 2023 30 October, 2023
Sernova Announces New Advancements of Conformal Coating Technology in Combination with the Cell Pouch System™ at the 2023 IPITA-IXA-CTRMS Joint Congress
LONDON, Ontario; WINDHAM COUNTY, Connecticut – October 30, 2023 – 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.
o Biocompatibility of the coated islets within the Cell Pouch was confirmed histologically demonstrating
healthy islets within the vascularized tissue matrix;
o Importantly, normal physiological transfer of glucose-stimulated insulin from the conformal coated islets
within the Cell Pouch was confirmed;
o 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:
o 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;
o 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:
Christopher Barnes
VP, Investor Relations
Sernova Corp.
christopher.barnes@sernova.com
Tel: 519-902-7923
www.sernova.com
Investors:
Corey Davis, Ph.D.
LifeSci Advisors, LLC
cdavis@lifesciadvisors.com
Tel: 212-915-2577
Media:
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.