2023 Press Releases Communiqués de presse
Sernova Announces Advancements with its Novel Cell Pouch SystemTM to Preserve Thyroid Function Following Total Thyroidectomy
Sernova and Evotec on Track to Initiate Clinical Testing of the First iPSC-Derived Islets in Cell Pouch as a Potential Functional Cure for Type 1 Diab
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Press Release Communiqué de presse - January 30, 2023 30 January, 2023
Sernova Announces Advancements with its Novel Cell Pouch SystemTM 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).
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.
“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.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Corporate:
Christopher Barnes
VP, Investor Relations
Sernova Corp.
christopher.barnes@sernova.com
Tel: 519-902-7923
www.sernova.com
Investors:
Corey Davis, Ph.D.
LifeSci Advisors, LLC
cdavis@lifesciadvisors.com
Tel: 212-915-2577
Media:
Elizabeth Miller, M.D.
LifeSci Communications
emiller@lifescicomms.com
Tel: 646-791-9705
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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Press Release Communiqué de presse - January 10, 2023 10 January, 2023
Sernova and Evotec on Track to Initiate Clinical Testing of the First iPSC-Derived Islets in Cell Pouch as a Potential Functional Cure for Type 1 Diabetes
- First iPSC-derived commercially viable off-the-shelf islet combination product is advancing towards
regulatory filing in 2024 for anticipated clinical trial authorization to treat patients with Type 1 Diabetes (T1D)
and severe hypoglycemia
- iPSC islet-like cluster manufacturing scale-up and tech transfer activities are well under way in preparation
for first human clinical evaluation
- T1D preclinical models with iPSC derived islet clusters transplanted in Sernova’s Cell Pouch has now
demonstrated consistent long-term insulin independence de-risking the combined technologies for both
companies
LONDON, Ontario – January 10, 2023 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a
clinical-stage company and leader in cell therapeutics, announced today that significant progress has been
achieved in its collaboration with Evotec SE (FSE: EVT; NASDAQ: EVO). This progress includes advancement
of Evotec’s iPSC derived islet-like clusters in combination with Sernova’s implantable Cell Pouch™ device
toward a first-in-human Phase 1/2 clinical trial for the treatment of patients with T1D and severe
hypoglycemia slated for regulatory filing in 2024. The objective of the collaboration is to produce an off the-
shelf, commercially viable, ethically derived cell therapy treatment for people suffering from T1D. The
treatment would include Sernova’s Cell Pouch System™ incorporating Evotec’s iPSC-derived islet-like
clusters. The combination product is anticipated to be the first treatment of its kind to reach clinical testing
for T1D.
The Evotec and Sernova collaboration has to date resulted in the following significant achievements:
- Development of a robust, cost-efficient, scalable, highly controlled iPSC differentiation protocol with the
ability to cryopreserve and store batches of differentiated islet-cell clusters
- Demonstration of excellent islet-like cluster survival under standard shipping conditions and following
transplantation
- Demonstration of consistent long-term insulin independence with no hypoglycemic events and consistent
safety profiles in a gold standard T1D preclinical model with Evotec’s iPSC-derived islet-like clusters
transplanted in Sernova’s Cell Pouch
- iPSC islet-like cluster manufacturing scale-up and technology transfer activities to Evotec’s iPSC GMP facility
are well under way in preparation for manufacture of clinical and commercial iPSC islet-like clusters supply
- Interactions with experts in support of design of the first Phase 1/2 clinical trial
Based on these achievements the following activities will be continuing throughout 2023 in preparation for
regulatory filings anticipated in 2024:
- Completion of standard formal safety/toxicology studies and other required preclinical studies
- Identification and securing of potential clinical study sites to enable efficient patient enrollment following
initiation of the Phase 1/2 clinical study
- Preparation of regulatory submissions for planned trial geographies, combining both the established library
of regulatory documentation for Sernova’s Cell Pouch and that developed by Evotec for their iPSC islet-like
clusters
Dr. Philip Toleikis, President and Chief Executive Officer of Sernova, commented, “Together Sernova and
Evotec maintain a shared, singular focus on developing the first combination product involving ethically
sourced iPSC-derived islet-like clusters within Sernova’s Cell Pouch for a type 1 diabetes functional cure
that could, conceivably, eliminate the need for daily insulin injections in patients with diabetes and
significantly reduce the burden on healthcare systems worldwide. Furthermore, we believe that Evotec’s
strategic design of its islet-like clusters to closely match human islets and the cost-efficient manufacturing
process combined with our collective approach to efficiently deliver the islet-like clusters to patients for
transplant into our Cell Pouch represents a disruptive and commercially attractive treatment, that could
one day treat people with insulin-dependent diabetes worldwide.”
Dr. Cord Dohrmann, Chief Scientific Officer of Evotec, commented, “Evotec’s iPSC-derived human beta
cells in combination with Sernova’s implantable Cell Pouch device represent a unique cell therapy product
opportunity aiming to provide a potential functional cure to insulin-dependent diabetic patients. The
combination product is highly differentiated through the quality of the cells and the device but also the
scalability of the manufacturing process of the iPSC-derived cells and therefore clearly positioned to
become the best-in-class cell therapy in the field.”
ABOUT SERNOVA CORP. AND THE CELL POUCH SYSTEM PLATFORM FOR CELL THERAPY
Sernova Corp. is a clinical-stage biotechnology company that is developing regenerative 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-based (induced pluripotent stem cells) 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: an implantable cell therapy for benign thyroid disease resulting from thyroid gland
removal and an ex-vivo lentiviral Factor VIII gene therapy for hemophilia A.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Corporate Investors Media
Christopher Barnes
VP, Investor Relations
Sernova Corp.
christopher.barnes@sernova.com
Tel: 519-902-7923
www.sernova.com
Corey Davis, Ph.D.
LifeSci Advisors, LLC
cdavis@lifesciadvisors.com
Tel: 212-915-2577
Elizabeth Miller, M.D.
LifeSci Communications
emiller@lifescicomms.com
Tel: 646-791-9705
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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Sernova, Corp.
1.519.858.5184
info@sernova.com
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Sernova Corp (TSX-V: SVA) is a clinical stage (US FDA; Health Canada) company, developing disruptive platform technologies to treat chronic diseases through a regenerative medicine approach. Sernova’s primary focus is in developing technologies for the treatment of patients with insulin-dependent (TI) diabetes, hemophilia A and thyroid disease. Sernova Corp (TSX-V: SVA) est une société en phase clinique (US FDA; Santé Canada) développant des applications thérapeutiques afin de traiter les maladies chroniques grâce à une approche régénérative. L’objectif principal de Sernova est de développer des technologies pour le traitement des patients atteints de diabète insulino-dépendant (T1), d’hémophilie A et de maladie de la glande thyroïde.
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