Press release Communiqué de presse
Press release Communiqué de presse
September 29, 2023 29 September, 2023
Sernova Presents Compelling New Data on the Cell Pouch System™ as a Promising Treatment for Post-Operative Hypothyroidism at the 2023 American Thyroid Association Annual Meeting
Proof-of-concept data supports the clinical evaluation of the Cell Pouch System as a potential treatment for
post-operative hypothyroidism
LONDON, Ontario; WINDHAM COUNTY, Connecticut – September 29, 2023 – Sernova Corp. (TSX:SVA)
(OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage company and leader in cell therapeutics, today announced
new preclinical data for its novel cell therapy platform, the Cell Pouch System, as a potential treatment for
post-operative hypothyroidism at the 2023 American Thyroid Association (ATA) Annual Meeting being held in
Washington, D.C., from September 27 to October 1, 2023.
Key insights from the poster:
• After total thyroidectomy, re-implantation of thyroid tissue into the pre-vascularized Cell Pouch™ resulted
in the restoration of the two main thyroid hormones, i.e., free thyroxine (FT4) and triiodothyronine (T3), to the
baseline levels.
• Thyroid stimulating hormone (TSH) levels had a significant peak immediately after thyroidectomy, with a
gradual decline observed starting five weeks after the re-implantation of thyroid glands. This pattern
underscores the re-establishment of the intrinsic thyroid feedback loop's impact.
• Newly reported radio-isotope uptake imaging and histology assessments confirmed the presence of
healthy and functional thyroid tissues within the Cell Pouch six months following re-implantation.
“Currently, thyroidectomy patients are bound to life-long thyroid hormone replacement therapy. A significant
subset of those patients grapple with persistent symptoms of thyroid dysfunction including weight gain, fatigue,
depression, memory and cognitive impairment, negatively impacting their quality of life,” said Cynthia
Pussinen, Chief Executive Officer at Sernova. “With Sernova’s Cell Pouch System, we aim to improve quality of
life with a treatment for post-operative hypothyroidism. These new data replicate a human clinical scenario in
which thyroid tissue is reimplanted into the patient, via the Cell Pouch, leading to the restoration of normal
thyroid function. Sernova is assessing the commercial opportunity and pathways for accelerated development
of the thyroid program.”
Approximately 150,000 thyroidectomies are performed annually in the U.S. alone, representing a significant
market opportunity*. Sernova’s potential first-generation product would utilize healthy tissue from the patient’s
own gland removed during thyroidectomy for benign disease. This therapeutic approach would negate the need
for immune suppression medication. A second-generation stem cell-derived technology could potentially be
used to treat the broader population with hypothyroid disease.
(*Sun, G. H., DeMonner, S., & Davis, M. M. (2013). Epidemiological and economic trends in inpatient and
outpatient thyroidectomy in the United States, 1996–2006. Thyroid, 23(6), 727-733.)
Poster details:
Title: Auto-Transplantation of Rat Thyroid into a Pre-Vascularized Retrievable Cell Pouch™ Device
for the Treatment of Post-Operative Hypothyroidism
Presenter: Dr. Arash Memarnejadian, Senior Research Scientist, Sernova Corp.
Date and Time: September 29 from 9:50 a.m. to 12:40 p.m. Eastern Time
Poster #: 323
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, with Cell Pouches implanted for periods of more than four years and counting.
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.
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:
Hannah Holmquist
LifeSci Communications
hholmquist@lifescicomms.com
Tel: 619-723-4326
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.