Sernova Announces Advancements with its Novel Cell Pouch System(TM) to Preserve Thyroid Function Following Total Thyroidectomy

• Preclinical proof of concept study demonstrates that thyroid auto-transplantation into the Cell Pouch can restore thyroid hormone production following removal of the thyroid gland
• Sernova has engaged with regulatory authorities towards initiating clinical development of a prospective therapy for hypothyroidism

LONDON, Ontario – January 30, 2023 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage company and leader in cell therapeutics, today announced advancements in its thyroid cell therapy program – one of three cell therapy development programs utilizing the Company’s  proprietary Cell Pouch System™. In a preclinical proof of concept study, the Company demonstrated that auto-transplantation of thyroid tissue into the Cell Pouch can compensate for removal of the thyroid gland (total thyroidectomy), restoring normal thyroid hormone levels in an animal model. 

The thyroid is a vital hormone-producing gland that is critical for metabolism and regulation of body functions.¹ Loss of thyroid function occurs following surgical removal of the gland and is associated with memory impairment, depression, intolerance to cold, chronic fatigue, constipation, weight gain and lethargy.²   It is estimated that more than 150,000 patients in the US undergo thyroidectomies annually³, and subsequently require lifelong thyroid hormone replacement therapy.

Despite some benefits, patients on thyroid replacement medications often experience significant impairment in psychological well-being.⁴ The primary goal of Sernova’s thyroid program is to restore normal thyroid function without life-long medication, and avoid the burden of repeated laboratory testing in patients who have undergone thyroid surgery.        

Data from Sernova’s preclinical program demonstrates that total thyroidectomy with auto-transplantation into the Cell Pouch allows for reestablishment of production of triiodothyronine (T3) and thyroxine (T4) and the hypothalamic-pituitary-thyroid axis.

The study was conducted in a pre-clinical animal model whereby the Cell Pouch was pre-implanted for several weeks prior to each subject undergoing total thyroidectomy.  The thyroid gland of each Treatment Group subject was removed, prepared with minimal manipulation, and transplanted into the pre-implanted Cell Pouch. Thyroid hormones were monitored over several months with weekly measurements of circulating thyroid hormones (T3, T4). Following thyroidectomy in the Treatment Group, the T3 and T4 levels fell initially but subsequently recovered to normal or near-normal levels following thyroid transplant into the Cell Pouch. Control Group subjects received the Cell Pouch implant and underwent total thyroidectomy but did not receive a thyroid transplant.  In the Control Group, post-thyroidectomy T3 and T4 rapidly decreased and remained below baseline concentrations throughout the experiment.

“Along with previously published preclinical data that reported survival and function of human thyroid tissue transplanted into the Cell Pouch⁵, this preclinical study also supports the viability of Sernova’s Cell Pouch System approach and represents an important step towards establishing an entirely new treatment option for post-thyroidectomy hypothyroidism,” commented Dr. Sam Wiseman, BSc, MD, FRCSC, FACS, Professor of Surgery, Faculty of Medicine at the University of British Columbia and attending surgeon at St. Paul’s Hospital in Vancouver.

“These findings demonstrate a further therapeutic application of Sernova’s Cell Pouch System,” said Dr. Philip Toleikis, President and Chief Executive Officer of Sernova. “In addition to type 1 diabetes [and hemophilia], this study shows the potential to treat the significant number of patients undergoing removal of their thyroid glands each year. We have already begun to interact with regulatory authorities towards initiating clinical trials with this novel therapy.”

Sernova intends to present data from the Company’s thyroid development program at a scientific conference later this year.
 

References

1. InformedHealth.org. Cologne, Germany: Institute for Quality and Efficiency in Health Care; How does the thyroid gland work? 2010 Nov 17 [Updated 2018 Apr 19]. https://www.ncbi.nlm.nih.gov/books/NBK279388/
2. Chaker L, Bianco AC, Jonklaas J, Peeters RP. Hypothyroidism. Lancet. 2017; 390: 1550–1562. https://doi.org/10.1016/S0140-6736(17)30703-1 PMID: 28336049
3. Al-Qurayshi Z, Robins R, Hauch A, Randolph GW, Kandil E. Association of Surgeon Volume With Outcomes and Cost Savings Following Thyroidectomy: A National Forecast. JAMA Otolaryngol Head Neck Surg. 2016;142(1):32–39. doi:10.1001/jamaoto.2015.2503
4. Saravanan P, Chau WF, Roberts N, Vedhara K, Greenwood R, Dayan CM. Psychological well-being in patients on 'adequate' doses of l-thyroxine: results of a large, controlled community-based questionnaire study. Clin Endocrinol (Oxf). 2002 Nov;57(5):577-85. doi: 10.1046/j.1365-2265.2002.01654.x. PMID: 12390330.
5. Wiseman SM, Memarnejadian A, Boyce GK, Nguyen A, Walker BA, Holmes DT, Welch ID, Mazzuca DM, Toleikis PM.  Subcutaneous transplantation of human thyroid tissue into a pre-vascularized Cell Pouch™ device in a Mus musculus model:  Evidence of viability and function for thyroid transplantation. PLoS One. 2022; 17(1): e0262345. https://doi.org/10.1371/journal.pone.0262345

ABOUT SERNOVA’S CELL THERAPY THYROID DISEASE PROGRAM

Sernova is utilizing its Cell Pouch System platform as a potential treatment for hypothyroid disease. Our approach is to transplant a patient’s own healthy thyroid tissue following thyroidectomy into the pre-implanted vascularized Cell Pouch to preserve the normal thyroid function and reduce or eliminate the need for lifelong daily thyroid replacement therapy. Sernova plans to conduct clinical assessments of the Cell Pouch with transplanted thyroid tissue in patients suffering from post-surgical hypothyroidism with the aim of preserving thyroid function and improving patient quality of life.

Thyroidectomy is commonly performed for cancer diagnosis or treatment and for treatment of benign (non-cancerous) disease that includes goiter and hyperthyroidism. It is estimated that about 150,000 thyroidectomies are performed in the US yearly. Patients undergoing total thyroidectomy, and many patients undergoing partial thyroidectomy, require life-long thyroid hormone medication. Post-surgical thyroid hormone replacement therapy, if monitored carefully, can be effective; however, patients often suffer from deleterious side-effects including weight gain, depression, headaches, and cardiovascular disease, with resultant negative impact on quality of life, and significant costs to the healthcare system. The development of new therapeutic strategies to overcome hypothyroidism remains an important unmet medical need.

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 a third development program that utilizes its Cell Pouch System with an ex vivo lentiviral Factor VIII gene therapy for hemophilia A.

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FORWARD-LOOKING INFORMATION

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