Sernova Announces First Two Patients Implanted with Cell Pouch™ in the Second Cohort of its US Phase 1/2 Clinical Trial for Type 1 Diabetes

• Company’s recent recruitment strategy change has resulted in an unprecedented level of inquiries regarding potential study participation
  
  
• Transplantation of islets into the enhanced 10-channel Cell Pouch is anticipated in early 2023
• Company continues to anticipate first interim safety/efficacy data from second cohort in 2023
  
  

LONDON, Ontario, Nov. 17, 2022 (GLOBE NEWSWIRE) -- 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 type 1 diabetes (T1D) clinical trial have been implanted with its 10-channel Cell Pouch, which provides >50% more capacity relative to the Cell Pouches used for the first cohort. The transition to this new 10-channel Cell Pouch under the revised protocol 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, changes in HbA1c, increased C-peptide production, and reduction in insulin requirements.

Sernova has engaged a clinical trial recruitment partner with extensive experience and success in accelerating T1D clinical trial patient enrollment. The second cohort of the study is intended to enroll up to seven patients with insulin dependent T1D who also suffer from severe hypoglycemic episodes and hypoglycemia unawareness. The Company anticipates reporting interim data in 2023. Results from the combined cohorts will inform the design of Sernova’s anticipated Phase 3 T1D pivotal study.

“Our drive to liberate individuals suffering with type 1 diabetes from the burden of daily insulin injections has been strengthened by the safety and efficacy observations in the first cohort of patients in our Phase 1/2 study, and we are pleased to have commenced the treatment phase for the second cohort,” said Dr. Philip Toleikis, President and Chief Executive Officer of Sernova. “We believe the new 10-channel Cell Pouch configuration provides for optimal dosing of islets towards achievement of a potential ‘functional cure’. We look forward to reporting interim data from the second cohort in 2023. Planning and preparations are underway for the pivotal trial program, while we advance our iPSC-derived islet program into the clinic in collaboration with Evotec.”   

ABOUT THE US PHASE 1/2 SECOND STUDY COHORT

The US Phase 1/2 study (NCT03513939) is an open-label single-arm trial to assess the safety, tolerability, and efficacy of Sernova’s Cell Pouch System™ for clinical transplantation of human donor islets in patients with T1D. Six patients were transplanted in the first cohort utilizing the 8-channel Cell Pouch System and interim data have been previously reported by Dr. Piotr Witkowski and his colleagues. With the expansion into the second cohort utilizing the 10-channel Cell Pouch System, patient eligibility criteria remain unchanged and includes those aged 18-65 with T1D who suffer from both hypoglycemic unawareness and severe hypoglycemic episodes, and who are eligible for donor islet transplantation. Eligible trial patients have had at least one episode of severe hypoglycemia in the previous 12 months and an absence of stimulated C-peptide (a marker of insulin production by the body) in response to a mixed meal tolerance test.

Islets are transplanted into the Cell Pouch approximately six weeks after Cell Pouch implantation to allow development of fully vascularized native tissue chambers and achieve a stable immunosuppressant regimen. At 90 days post-islet transplant, safety and efficacy are assessed prior to initiating a second transplant of islets. At 90 days following each patient’s second islet transplant to Cell Pouch, safety and efficacy endpoints are evaluated again. Trial patients who remain dependent on insulin for at least 6 months following the second islet transplant to Cell Pouch may be eligible for a third supplemental islet transplant via the portal vein.

Patients who elect to retain their implants will be followed for up to 3 years after the final islet transplant into the Cell Pouch. Multiple transplanted patients from the first cohort have implant durations of more than 3 years and none have elected to have their Cell Pouch implants removed.

The primary objective of the Phase 1/2 study is safety and tolerability. Secondary objectives include the following efficacy endpoints: production of C-peptide, insulin use, HbA1c and frequency of hypoglycemic events.

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.

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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 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.