Press release Communiqué de presse
Press release Communiqué de presse
June 6, 2022 6 June, 2022
Sernova Announces Positive Updated Phase 1/2 Clinical Data on Cell Pouch System™ at American Diabetes Association 82nd Scientific Sessions 2022
• Researchers from the Dr. Piotr Witkowski Laboratory at the University of Chicago presented updated data
on six patients with type 1 diabetes and hypoglycemia unawareness
• The first three patients have been insulin independent for over 2 years, 6 months, and 3 months,
respectively
• Those first three patients with islets transplanted into the Cell Pouch™ subsequently presented positive
serum C-peptide values confirming active insulin production by the Cell Pouch islet grafts
• The Cell Pouch was well tolerated with implant durations exceeding 35 months
LONDON, Ontario – June 6, 2022 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-
stage company and leader in regenerative medicine cell therapeutics, today announced the presentation of
clinical data from its Phase 1/2 clinical trial supporting the potential of its proprietary Cell Pouch System to
provide a ‘functional cure’ for insulin-dependent diabetes. The updated data from the ongoing study being
conducted by Piotr Witkowski, M.D., Ph.D. at the University of Chicago, were presented as an oral podium
presentation at the American Diabetes Association (ADA) 82nd Scientific Sessions, held from June 3-7, 2022, at
the Ernest N. Morial Convention Center in New Orleans, LA.
The presented data, from the Dr. Piotr Witkowski Laboratory at the University of Chicago, reviewed the six
patients who lived with long-standing insulin-dependent type 1 diabetes (T1D) and hypoglycemia unawareness
prior to study treatment who underwent both Cell Pouch implantation and islet transplantation. Graft function
was measured by blood glucose, patient insulin usage, and C-peptide, a widely used measure of islet function.
The first three patients achieved complete and sustained insulin independence. Three additional patients on
study did not maintain optimal immunosuppression, which has now been resolved enabling those patients to
receive further protocol-defined islet transplants.
Key findings from interim clinical update:
• Surgical implantation of the Cell Pouch was found to be generally well tolerated with a favorable safety
profile
• All patients who had favorable immunosuppression achieved complete insulin independence
o The first three transplanted patients presented positive serum C-peptide values confirming active
insulin production after islet transplantation into the Sernova Cell Pouch
o Supplemental marginal dose islet transplantation via the portal vein was sufficient to allow those
three patients to achieve and maintain insulin independence for over 2 years, 6 months, and 3
months, respectively
o Insulin independent patients have HbA1c in the normal range: 5.0, 5.2, and 5.2%, respectively
• Dr. Witkowski further optimized outcomes in the ongoing clinical trial:
o Replacing patients’ own plasma with serum as the islet suspension medium
o Decreasing the concentration of islet suspensions transplanted to Cell Pouch resulted in greater
stimulated C-peptide
o The Cell Pouch implantation procedure was optimized with two shorter incisions to minimize
infection risk and enhance healing
o Implementing a higher capacity Cell Pouch System, that has been developed by Sernova, will
provide approximately 50% more volume to accommodate more islets at the optimal
concentration for use in future implantation procedures
“Despite some advances in the diabetes space, insulin-dependent diabetes patients continue to require
numerous injections daily, and for those with hypoglycemia unawareness, it can be increasingly life threatening.
We are committed to developing a ‘functional cure’ to potentially free patients from the life-limiting burdens of
this disease,” said Dr. Philip Toleikis, President and Chief Executive Officer of Sernova. “We are encouraged by
the data demonstrating our Cell Pouch System has been well tolerated and multiple patients remain insulin
independent. We remain on track to further dose the three aforementioned subjects and to implement the
higher capacity Cell Pouch System in the next implanted patients.”
The incidence of T1D in the U.S. (in ages 0 to 64 years) is estimated to be 64,000 cases annually, with a
predicted prevalence of 5 million people by 2050 (1,2). The annual direct cost of healthcare expenditures and
lost income from T1D has been estimated as $16 billion (3). Sernova’s Cell Pouch System is designed to
address this vastly expanding need by providing a ‘functional cure’ for the millions of people afflicted by
insulin-dependent diabetes worldwide. Sernova is also addressing the life-threatening complication of
hypoglycemia unawareness (HU) in patients with T1D. HU is a person’s inability to recognize the symptoms of
low blood sugar before it becomes severe enough to be incapacitating or even fatal. About 1 in 5 people with
T1D report experiencing hypoglycemia unawareness (4).
Dr. Piotr Witkowski, Director of Pancreatic Islet Transplantation Program at University of Chicago and study
Principal Investigator added, “The data coming out of the Cell Pouch and islet transplantation trial show
incredible promise for insulin-dependent diabetes patients. I am excited about the potential impact on the field
and look forward to seeing continued progression of the data from this trial.”
Sernova recently entered into a global strategic partnership with Evotec A.G., a Nasdaq listed biotechnology
company, to develop an implantable off-the-shelf induced pluripotent stem cell (iPSC) -based beta cell
replacement therapy, which will provide Sernova with an unlimited supply of insulin-producing cells,
circumventing any potential future islet supply issues. Sernova is also working to eliminate the need for chronic
immunosuppression with cell transplants by incorporating technology developed by Dr. Alice Tomei’s
laboratory at the University of Miami, to protect cells from immune system recognition.
For more information on the ongoing clinical study, go to clinicaltrials.gov (NCT03513939).
1. Rogers MAM, Kim C, Banerjee T, Lee JM. Fluctuations in the incidence of type 1 diabetes in the United
States from 2001 to 2015: a longitudinal study. BMC Med. 2017;15(1):199. Published 2017 Nov 8.
doi:10.1186/s12916-017-0958-6
2. Dabelea D, Mayer-Davis EJ, Saydah S, et al. Prevalence of type 1 and type 2 diabetes among children and
adolescents from 2001 to 2009. JAMA. 2014;311(17):1778-1786. doi:10.1001/jama.2014.3201
3. American Diabetes Association. Economic Costs of Diabetes in the U.S. in 2017. Diabetes Care.
2018;41(5):917-928. doi:10.2337/dci18-0007
4. Reno CM, Litvin M, Clark AL, Fisher SJ. Defective counterregulation and hypoglycemia unawareness in
diabetes: mechanisms and emerging treatments. Endocrinol Metab Clin North Am. 2013;42(1):15-38.
doi:10.1016/j.ecl.2012.11.005
ABOUT SERNOVA CORP. AND THE CELL POUCH SYSTEM PLATFORM FOR CELL THERAPY
Sernova Corp is a clinical-stage biotechnology company that is developing regenerative medicine therapeutic
technologies for chronic diseases, including insulin-dependent diabetes, thyroid disease, and blood disorders
like hemophilia A. Sernova is currently focused on finding a ‘functional cure’ for insulin-dependent diabetes
with its lead asset, the Cell-Pouch SystemTM, a novel implantable and scalable medical device which forms a
natural environment in the body for long-term survival and function of therapeutic cells that release necessary
proteins or factors missing from the body to treat chronic diseases. Sernova’s Cell Pouch System has already
shown it can potentially provide a ‘functional cure’ to people with type 1 diabetes in an ongoing Phase I/II study
at the University of Chicago. Sernova is also working on technology with the University of Miami to cloak the
implant from the immune system, to eliminate the need for immunosuppressives to protect the cells from
immune system attack. 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) beta cell replacement therapy. This
partnership provides Sernova an unlimited supply of insulin-producing cells to treat millions of patients with
insulin-dependent diabetes (type 1 and type 2). Sernova is also gearing up to be in the clinic in two 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 8 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
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.