Press release Communiqué de presse
Press release Communiqué de presse
March 8, 2023 8 March, 2023
Sernova Announces Initial Islet Transplantation in First Two Patients Enrolled in Second Cohort of its U.S. Phase 1/2 Clinical Trial for Treatment of Type 1 Diabetes
- Third patient now implanted with higher capacity, 10-chamber Cell Pouch
- Company anticipates first interim data from second cohort in Q4 2023
LONDON, Ontario – March 8, 2023 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-
stage company and leader in cell therapeutics, announced today that the first two patients in the second cohort
of its active U.S. Phase 1/2 clinical trial for the treatment of type 1 diabetes (“T1D”) and hypoglycemia
unawareness (the “T1D Study”) received their first islet transplant into the higher capacity 10-channel Cell
Pouch™. These patients will be monitored for safety and efficacy for three months after which a second dose of
islets is anticipated to be transplanted in accordance with the protocol. Additionally, a third enrolled patient
has now been implanted with the higher capacity Cell Pouch and awaits islet transplant in the coming weeks.
In November 2022, the Company announced the addition of a second cohort and protocol amendment for its
T1D Study. The amended protocol includes a second cohort of up to seven patients for the transplant of islets
into Sernova’s higher-capacity Cell Pouch. Enrollment for the new second cohort has occurred rapidly with
approximately half of the patients already completed.
The amended protocol to use the 10-channel Cell Pouch enables optimized dosing and shorter efficacy
evaluation periods to ultimately decrease time to key efficacy endpoints. These endpoints include survival of
transplanted islet cells, reduction of severe hypoglycemic episodes, and changes in HbA1c, serum C-peptide
production, and insulin requirements. The higher capacity 10-channel Cell Pouch provides greater than 50%
more capacity relative to the Cell Pouches used for the T1D Study’s first cohort.
“I am excited to apply the learnings from the first patient cohort, including implementation of the higher
capacity Cell Pouch, which enables us to optimize the dose and concentration of islets to achieve our clinical
objectives with these patients,” said Dr. Piotr Witkowski, Clinical Trial Principal Investigator and Director of the
Pancreatic Islet Transplant Program at the University of Chicago. “I look forward to reporting the first interim
results of the second patient cohort.”
Dr. Philip Toleikis, President and Chief Executive Officer of Sernova, added, “With the first two patients
transplanted and a third patient now implanted with the higher capacity Cell Pouch, we are pleased to see the
successful results of our patient enrollment acceleration strategy and are driving to complete full enrollment as
expeditiously as possible. We look forward to presenting our next readout of interim results.”
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 SE 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
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.