Sernova Announces Initial Islet Transplantation in First Two Patients Enrolled in Second Cohort of its U.S. Phase 1/2 Clinical Trial for Treatment of Type 1 Diabetes

Issuer: Sernova Corp. / Key word(s): Study/Study results
08.03.2023 / 13:05 CET/CEST
The issuer is solely responsible for the content of this announcement.

• Third patient now implanted with higher capacity, 10-chamber Cell Pouch
• Company anticipates first interim data from second cohort in Q4, 2023 

LONDON, Ontario – March 8, 2023 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage company and leader in cell therapeutics, announced today that the first two patients in the second cohort of its active U.S. Phase 1/2 clinical trial for the treatment of type 1 diabetes (“T1D”) and hypoglycemia unawareness (the “T1D Study”) received their first islet transplant into the higher capacity 10-channel Cell Pouch™.  These patients will be monitored for safety and efficacy for three months after which a second dose of islets is anticipated to be transplanted in accordance with the protocol. Additionally, a third enrolled patient has now been implanted with the higher capacity Cell Pouch and awaits islet transplant in the coming weeks. 

In November 2022, we announced the addition of a second cohort and protocol amendment for our T1D Study. The amended protocol includes a second cohort of up to seven patients for the transplant of islets into Sernova’s higher-capacity Cell Pouch. Enrollment for the new second cohort has occurred rapidly with approximately half of the patients already completed. 

The amended protocol to use the 10-channel Cell Pouch enables optimized dosing and shorter efficacy evaluation periods to ultimately decrease time to key efficacy endpoints. These endpoints include survival of transplanted islet cells, reduction of severe hypoglycemic episodes, and changes in HbA1c, serum C-peptide production, and insulin requirements. The higher capacity 10-channel Cell Pouch provides greater than 50% more capacity relative to the Cell Pouches used for the T1D Study’s first cohort.

“I am excited to apply the learnings from the first patient cohort, including implementation of the higher capacity Cell Pouch, which enables us to optimize the dose and concentration of islets to achieve our clinical objectives with these patients,” said Dr. Piotr Witkowski, Clinical Trial Principal Investigator and Director of the Pancreatic Islet Transplant Program at the University of Chicago.  “I look forward to reporting first interim results of the second patient cohort.”

Dr. Philip Toleikis, President and Chief Executive Officer of Sernova, added, “With the first two patients transplanted and a third patient now implanted with the higher capacity Cell Pouch, we are pleased to see the successful results of our patient enrollment acceleration strategy and are driving to complete full enrollment as expeditiously as possible. We look forward to presenting our next readout of interim results.”

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 SE 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.

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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.sedar.com 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.

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