Press release Communiqué de presse
Press release Communiqué de presse
June 26, 2023 26 June, 2023
Sernova Announces Positive Updated Interim Phase 1/2 Clinical Data for the Cell Pouch System™ at American Diabetes Association 83rd Scientific Sessions
• In the first cohort of the ongoing Phase 1/2 clinical trial, the first 5 patients to complete protocol-defined
islet transplants achieved insulin-independence for ongoing periods of 6 to 38 months.
• Following islet transplants to the 8-channel Cell Pouches, patients in the first cohort required only modest
islet top-up via portal vein to achieve insulin independence, supporting the contribution to blood glucose
control from islet grafts in the Cell Pouch™.
• Five of the 7 planned patients have been enrolled in the second cohort and implanted with higher capacity
10-channel Cell Pouches. Three patients in the second cohort have received their first pancreatic islet
transplant to Cell Pouch.
• Persistent fasting and stimulated serum C-peptide confirms stable islet graft function in the first evaluable
patient to receive islet transplants to the higher capacity Cell Pouch.
LONDON, Ontario – June 26, 2023 – Sernova Corp. (TSX: SVA) (OTCQB: SEOVF) (FSE/XETRA: PSH), a clinical-
stage company and leader in cell therapeutics, today announced updated positive interim data from its ongoing
Phase 1/2 clinical trial of the Cell Pouch System in patients with type 1 diabetes (T1D) and severe hypoglycemia
unawareness. The new data from the study, which is being conducted by Piotr Witkowski, M.D., Ph.D., at The
University of Chicago, were presented during an oral podium presentation at the American Diabetes
Association (ADA) 83rd Scientific Sessions, on June 24th, 2023 in San Diego, California.
The presentation discussed the first eleven patients enrolled across two cohorts in the clinical trial evaluating
Cell Pouch in combination with pancreatic islets and reconfirmed the safety of Cell Pouch up to more than 4
years following implant. During the trial, the function of the transplanted islets are measured by blood glucose
levels, patient insulin usage, and serum C-peptide - a measure of islet insulin secretion.
To date, 5 patients in the first cohort of 6 subjects who have completed Cell Pouch implantation, islet
transplant to Cell Pouch, and supplemental portal vein islet infusion, continue to experience insulin
independence for periods ranging from 6 months to greater than 3 years. The sixth patient in the first cohort
has only recently completed the protocol-defined islet transplants and awaits assessment of their islet graft
function.
In addition, updates were provided for the second cohort with the recently implemented 10-channel Cell Pouch
with more than 50% greater transplant capacity than the previous 8-channel system. Five of 7 patients meeting
the trial eligibility criteria have been enrolled in the second cohort and implanted with the higher capacity Cell
Pouch. Three of the 5 patients enrolled in the second cohort have each received a first islet transplant to their
implanted Cell Pouches. The first evaluable patient in the second cohort has demonstrated persistent fasting
and stimulated serum C-peptide levels following a single islet transplant into the pre-vascularized 10-channel
Cell Pouch.
KEY POINTS FROM THE INTERIM CLINICAL UPDATE
• Long-term surgical implantation of the Cell Pouch continues to be well tolerated with a favorable safety
profile in patients receiving either 8 or 10-channel Cell Pouches.
• Five of 6 patients in the first cohort achieved insulin independence following supplemental islet transplants
via the portal vein that were below the typical intraportal islet dose, indicating that islet graft function in the 8-
channel Cell Pouch is supporting ongoing glucose control.
• Histological assessment of sentinel Cell Pouches excised at ≥90 days post-transplant revealed surviving
functional islets in 5 of 6 patients in the first cohort.
• The 5 patients in the first cohort that have achieved insulin independence have each remained free of
endogenous insulin therapy ranging from 6 months to greater than 3 years. The sixth patient in the first cohort
has recently completed the protocol-defined islet transplants and is awaiting their next islet graft assessment.
• In the second cohort, 5 of 7 planned patients are now enrolled and implanted with the higher capacity Cell
Pouches. Three of the 5 patients have received their first dose of pancreatic islets transplanted to Cell Pouch.
• One patient in the second cohort has demonstrated persistent serum C-peptide levels after only a single
islet transplant into 10-channel Cell Pouch. The first patient in the second cohort developed persistent
neutropenia requiring cessation of immunotherapy. The third patient awaits their first islet graft assessment.
Further data from the second cohort of the clinical trial is expected in the second half of 2023.
“We are very pleased to see these positive data for our T1D trial with Cell Pouch, and especially our 10-
channel Cell Pouch configuration, as we pursue a ‘functional cure’ for patients with T1D,” said Dr. Philip
Toleikis, President and Chief Executive Officer of Sernova. “These additional data continue to confirm our
understanding and provide verification of our estimates of islet dose thresholds and density required for
optimal efficacy in this patient population. We continue to follow through on our commitment to rapidly enroll
the study’s second cohort, while setting the stage for Cell Pouch in combination with Evotec’s iPSC derived
islet-like clusters in our upcoming clinical trial.”
Dr. Piotr Witkowski, Director of the Pancreatic and Islet Transplant Program at The University of Chicago, and
principal investigator of the clinical trial added, “I continue to be encouraged by the results achieved in this
trial, and especially by the ease of use and favorable response from a single islet transplant to the larger Cell
Pouch. I look forward to reporting further data later this year.”
For more information on the ongoing clinical study, go to clinicaltrials.gov (NCT03513939).
To add to the ongoing Phase 1/2 clinical trial of the Cell Pouch System in T1D, Sernova also continues to
advance its global strategic partnership with Evotec SE (Evotec). Together the companies remain on track to
advance Sernova’s Cell Pouch in combination with Evotec’s induced pluripotent stem cell (iPSC) derived islet-
like clusters into the clinic. Furthermore, Sernova is advancing its conformal coating cellular immune
protection technologies in collaboration with the University of Miami with the goal to reduce or eliminate the
need for immunosuppression agents.
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 two additional development programs that utilize its Cell Pouch System: a novel 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.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.