Sernova Announces Positive Updated Interim Phase 1/2 Clinical Data for the Cell Pouch System™ at American Diabetes Association 83rd Scientific Sessions

• In the first cohort of the ongoing Phase 1/2 clinical trial, the first 5 patients to complete protocol-defined islet transplants achieved insulin-independence for ongoing periods of 6 to 38 months.
• Following islet transplants to the 8-channel Cell Pouches, patients in the first cohort required only modest islet top-up via portal vein to achieve insulin independence, supporting the contribution to blood glucose control from islet grafts in the Cell Pouch™.
• Five of the 7 planned patients have been enrolled in the second cohort and implanted with higher capacity 10-channel Cell Pouches. Three patients in the second cohort have received their first pancreatic islet transplant to Cell Pouch.
• Persistent fasting and stimulated serum C-peptide confirms stable islet graft function in the first evaluable patient to receive islet transplants to the higher capacity Cell Pouch.

LONDON, Ontario, June 26, 2023 (GLOBE NEWSWIRE) -- Sernova Corp. (TSX: SVA) (OTCQB: SEOVF) (FSE/XETRA: PSH), a clinical-stage company and leader in cell therapeutics, today announced updated positive interim data from its ongoing Phase 1/2 clinical trial of the Cell Pouch System in patients with type 1 diabetes (T1D) and severe hypoglycemia unawareness. The new data from the study, which is being conducted by Piotr Witkowski, M.D., Ph.D., at The University of Chicago, were presented during an oral podium presentation at the American Diabetes Association (ADA) 83rd Scientific Sessions, on June 24th, 2023 in San Diego, California.

The presentation discussed the first eleven patients enrolled across two cohorts in the clinical trial evaluating Cell Pouch in combination with pancreatic islets and reconfirmed the safety of Cell Pouch up to more than 4 years following implant. During the trial, the function of the transplanted islets are measured by blood glucose levels, patient insulin usage, and serum C-peptide - a measure of islet insulin secretion.

To date, 5 patients in the first cohort of 6 subjects who have completed Cell Pouch implantation, islet transplant to Cell Pouch, and supplemental portal vein islet infusion, continue to experience insulin independence for periods ranging from 6 months to greater than 3 years. The sixth patient in the first cohort has only recently completed the protocol-defined islet transplants and awaits assessment of their islet graft function.

In addition, updates were provided for the second cohort with the recently implemented 10-channel Cell Pouch with more than 50% greater transplant capacity than the previous 8-channel system. Five of 7 patients meeting the trial eligibility criteria have been enrolled in the second cohort and implanted with the higher capacity Cell Pouch. Three of the 5 patients enrolled in the second cohort have each received a first islet transplant to their implanted Cell Pouches. The first evaluable patient in the second cohort has demonstrated persistent fasting and stimulated serum C-peptide levels following a single islet transplant into the pre-vascularized 10-channel Cell Pouch.

KEY POINTS FROM THE INTERIM CLINICAL UPDATE

• Long-term surgical implantation of the Cell Pouch continues to be well tolerated with a favorable safety profile in patients receiving either 8 or 10-channel Cell Pouches.
• Five of 6 patients in the first cohort achieved insulin independence following supplemental islet transplants via the portal vein that were below the typical intraportal islet dose, indicating that islet graft function in the 8-channel Cell Pouch is supporting ongoing glucose control.
• Histological assessment of sentinel Cell Pouches excised at ≥90 days post-transplant revealed surviving functional islets in 5 of 6 patients in the first cohort.
• The 5 patients in the first cohort that have achieved insulin independence have each remained free of endogenous insulin therapy ranging from 6 months to greater than 3 years. The sixth patient in the first cohort has recently completed the protocol-defined islet transplants and is awaiting their next islet graft assessment.
• In the second cohort, 5 of 7 planned patients are now enrolled and implanted with the higher capacity Cell Pouches. Three of the 5 patients have received their first dose of pancreatic islets transplanted to Cell Pouch.
• One patient in the second cohort has demonstrated persistent serum C-peptide levels after only a single islet transplant into 10-channel Cell Pouch. The first patient in the second cohort developed persistent neutropenia requiring cessation of immunotherapy. The third patient awaits their first islet graft assessment.

Further data from the second cohort of the clinical trial is expected in the second half of 2023.

“We are very pleased to see these positive data for our T1D trial with Cell Pouch, and especially our 10-channel Cell Pouch configuration, as we pursue a ‘functional cure’ for patients with T1D,” said Dr. Philip Toleikis, President and Chief Executive Officer of Sernova. “These additional data continue to confirm our understanding and provide verification of our estimates of islet dose thresholds and density required for optimal efficacy in this patient population. We continue to follow through on our commitment to rapidly enroll the study’s second cohort, while setting the stage for Cell Pouch in combination with Evotec’s iPSC derived islet-like clusters in our upcoming clinical trial.”

Dr. Piotr Witkowski, Director of the Pancreatic and Islet Transplant Program at The University of Chicago, and principal investigator of the clinical trial, added, “I continue to be encouraged by the results achieved in this trial, and especially by the ease of use and favorable response from a single islet transplant to the larger Cell Pouch. I look forward to reporting further data later this year.”

For more information on the ongoing clinical study, go to clinicaltrials.gov (NCT03513939).

To add to the ongoing Phase 1/2 clinical trial of the Cell Pouch System in T1D, Sernova also continues to advance its global strategic partnership with Evotec SE (Evotec). Together the companies remain on track to advance Sernova’s Cell Pouch in combination with Evotec’s induced pluripotent stem cell (iPSC) derived islet-like clusters into the clinic. Furthermore, Sernova is advancing its conformal coating cellular immune protection technologies in collaboration with the University of Miami with the goal to reduce or eliminate the need for immunosuppression agents.

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 novel 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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