Ms. Cynthia Pussinen reports

SERNOVA ANNOUNCES POSITIVE ONGOING INTERIM PHASE 1/2 CLINICAL DATA FOR THE CELL POUCH SYSTEM FOR TYPE 1 DIABETES TRIAL AT THE 2023 IPITA, IXA, AND CTRMS JOINT CONGRESS

Sernova Corp. released positive interim results from the continuing phase 1/2 clinical trial investigating islet allotransplantation into its prevascularized Cell Pouch during an oral presentation at the 2023 IPITA, IXA and CTRMS Joint Congress in San Diego, Calif. Enrolment in cohort A, which utilizes the eight-channel Cell Pouch, is complete, with posttransplant data available for periods of follow-up ranging from six months to 3.5 years. Enrolment in cohort B, which utilizes the higher-capacity Cell Pouch and a revised and better-tolerated immunosuppressive regimen, began in November, 2022, and six of the seven planned patients have now been successfully implanted.

The primary objective of the study is to investigate the safety and tolerability of islet transplantation into the Cell Pouch in patients with Type 1 diabetes, impaired hypoglycemia awareness and a history of severe hypoglycemic episodes. Secondary study objectives include establishment of islet release criteria predictive of outcomes from islet transplant into the Cell Pouch and optimal dose and concentration ranges for purified islets transplanted into the Cell Pouch.

Interim results from cohort A demonstrated successful implantations of the eight-channel Cell Pouch in the six treated patients that were well tolerated with no seromas and no unexpected AEs (adverse events), chronic pain or discomfort. Data showed histological evidence of surviving and functional islets and positive fasting and stimulated serum C-peptide (a measure of islet insulin secretion) in patients who maintained optimal immunosuppression. All six patients eventually received supplemental, marginal-dose islet infusions via the portal vein, with the first five having achieved sustained insulin independence. All six cohort A patients achieved HbA1c values in the non-diabetic range (less than 6.5 per cent) with persistent serum fasting and stimulated C-peptide levels for current durations out to 3.5 years.

In cohort B, six of the planned seven patients have been implanted with the higher-capacity 10-channel Cell Pouch, without complications. Among the six patients that have been implanted, five have completed at least one of the two protocol-defined islet transplants to the Cell Pouch.

The first assessable patient in cohort B following the first Cell Pouch islet transplant showed persistent fasting and stimulated serum C-peptide, with stable BETA-2 scores (a measure of islet graft function) that continued at day 180 following the patient's first islet transplant to the Cell Pouch. The same patient showed modest but favourable improvements in HbA1c from 7.5 per cent at baseline to 6.9 per cent also at day 180.

The day following the second islet transplant to the Cell Pouch, results from a sample of the islets taken from the donor pancreas on the day of transplant came back positive for the yeast, Candida albicans. Out of an abundance of caution, Cell Pouches containing the contaminated islets were immediately removed. The Cell Pouches that were previously transplanted with the first dose of uncontaminated, healthy islets were not removed and remained in place, continuing to function. Explantation of the Cell Pouches containing contaminated islets was completed without complications and the patient fully recovered without any wound or systemic blood infection, demonstrating the designed retrievability of the transplanted Cell Pouch. Following recovery, this patient received a modest intraportal islet transplant and remains insulin independent.

The revised immunosuppression protocol, used in cohort B, continues to demonstrate favourable protection for the islet grafts, with no donor islet rejection or donor-specific antibodies observed under the new regimen.

"I am pleased with the overall patient outcomes and learnings from the first trial cohort. We have applied those learnings to the second patient cohort along with the introduction of the higher-capacity 10-channel Cell Pouch," commented Dr. Piotr Witkowski, director of the pancreatic and islet transplant program at the University of Chicago, principal investigator for the Sernova trial. "I am encouraged by the positive safety profile observed with Cell Pouch implants longer than four years, and early patient outcomes with the enhanced 10-channel device that we are using in the second cohort. Enrolment of the second cohort is nearly complete, and I look forward to reporting further results."

"We are very encouraged by the results and our learnings from our trial to date," said Cynthia Pussinen, chief executive officer of Sernova. "Having recently advanced the trial into cohort B, using our higher-capacity 10-channel Cell Pouch, we are already seeing positive signals for both safety and efficacy. We look forward to sharing the next trial update, in the coming months."

About Sernova Corp.

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, 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 Type 1 diabetes in a continuing 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 attacks, 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-based (induced pluripotent stem cells) 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: (i) a cell therapy for hypothyroid disease resulting from thyroid gland removal; and (ii) an ex vivo lentiviral Factor VIII gene therapy for hemophilia A.

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