• To date Sernova reports 7 patients in its Phase I/II type 1 diabetes clinical trial achieved freedom from insulin injections and demonstrate blood sugar control in the non-diabetic range (HbA1c 6.5%); 

• 6 patients have reached between 5.5 and 50 months of sustained insulin independence and freedom from severe hypoglycemic episodes; 

• Completion of enrollment in Cohort 2 

LONDON, Ontario; BOSTON, Massachusetts – June 25, 2024 – TheNewswire – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage biotechnology company, today announces developments in its Phase I/II clinical trial investigating a novel treatment for Type 1 Diabetes (T1D). To date a total of 7 patients across Cohorts 1 and 2 have achieved insulin independence following transplants of human donor islets via Sernova’s proprietary Cell Pouch System™ and a marginal portal vein top up.  Additionally, the study, which is being conducted at the University of Chicago, completed full enrollment of the second cohort of patients with the last patient being enrolled June 24, 2024.  

At baseline, all patients in the study were dependent on multiple daily insulin injections with average HbA1c levels (a measure of glucose control over the prior 2 to 3 months) greater than 6.5% across the study population.  In addition, prior to enrollment in the study, patients had a history of severe hypoglycemic events (a potentially life-threatening drop in blood sugar leading to impaired cognition and consciousness) and undetectable plasma levels of C-peptide (a marker of natural insulin production).  Insulin independence in these first 7 patients has been accompanied by freedom from severe hypoglycemic events, sustained HbA1c levels in the non-diabetic range (HbA1c <6.5%), and persistent transplant-mediated insulin production measured by plasma C-peptide.  

 

The trial, which focuses on Sernova’s Cell Pouch technology, demonstrates that insulin independence and additional clinically meaningful patient outcomes were achieved with lower than traditional islet masses infused intra-portally, indicating an important contribution of the islet grafts in Cell Pouch to the observed favorable blood glucose control.  Sernova continues to be the first and only company to announce positive patient outcomes in a clinical trial for T1D that combines donor islets transplanted via an implantable delivery vehicle that also has full payload containment and retrievability capabilities should it be required, as evidenced by the first patient in Cohort 2. Interim data from this study indicates that Cell Pouch is generally safe and well tolerated and, when transplanted with donor islets, contributes to the reversal of T1D, potentially minimizing the long-term comorbidities that include heart and kidney disease, blindness and amputation. The Company anticipates announcing additional trial results for the remaining 5 patients

in Cohort 2, later in the year.

Cynthia Pussinen, CEO of Sernova, expressed "we are excited with and encouraged by the impressive progress of our ongoing Phase I/II clinical trial with donor islets and Cell Pouch. The ability to achieve sustained insulin independence, HbA1c levels in the non-diabetic range and reductions in severe hypoglycemic events in patients, using a retrievable payload device, signifies a transformative step forward in the treatment – and essentially functional cure - of Type 1 Diabetes. Sernova remains committed to advancing the potential of our Cell Pouch technology to significantly improve the lives of patients and their families worldwide.”  

Sernova Corp continues to collaborate closely with leading academic, pharmaceutical and clinical institutions to expand the scope and impact of its technology. The company anticipates further advancements as it progresses through additional cohorts and trials, with the goal of offering a scalable solution for insulin-dependent diabetes plus other chronic diseases.

About Sernova

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 technology, the Cell Pouch System, a novel implantable and scalable medical device with immune protected therapeutic cells.

Sernova partnered with Evotec 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’s development pipeline that uses its Cell Pouch System also includes: a cell therapy for hypothyroid disease resulting from thyroid gland removal and an ex vivo lentiviral Factor VIII gene therapy for hemophilia A.

About Sernova’s Cell Pouch for use with Cell Therapeutics

On implantation, The Cell Pouch forms a natural, vascularized tissue environment in the body allowing 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. The Cell Pouch technology integrates with the body's natural biological processes, creating a biocompatible environment for the delivery of therapeutic cells previously missing from the body including cells, hormones, blood factors and tissues. This innovative approach aims to provide a durable and sustainable treatment option for Sernova’s lighthouse program to treat individuals living with T1D, with additional future therapeutic programs to follow for hypothyroidism and hemophilia A.

For further information, please contact:

Christopher Barnes

VP, Investor Relations

Sernova Corp.

Tel: +1 519-902-7923

Email: christopher.barnes@sernova.com

Website: www.sernova.com

 

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.