2023 Press Releases Communiqués de presse
Sernova Announces Abstract on First Cohort of its Phase 1/2 Study Involving Islet Allotransplantation into Pre-vascularized Cell Pouch™ Selected for
Sernova Announces Upcoming Podium Presentation of iPSC and Cell Pouch™ Combination Treatment for Type One Diabetes at the 4th IPITA / HSCI / JDRF Su
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
Sernova to Participate in Upcoming Roth and Oppenheimer Investor Conferences
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 - March 22, 2023 22 March, 2023
Sernova Announces Abstract on First Cohort of its Phase 1/2 Study Involving Islet Allotransplantation into Pre-vascularized Cell Pouch™ Selected for Oral Podium Presentation at American Diabetes Association 83rd Scientific Sessions 2023
LONDON, Ontario – March 22, 2023 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-
stage company and leader in cell therapeutics, is pleased to announce that an abstract has been selected for
an oral podium presentation at the upcoming American Diabetes Association (ADA) 83rd Scientific Sessions, to
be held from June 23-26, 2023, in San Diego, CA. It will also be published on the journal Diabetes® website.
Abstract: #240-OR
Title: Islet Allotransplantation into Pre-vascularized Sernova Cell Pouch—Early Results from the University of
Chicago
Abstract Session: Clinical Islet-Cell Transplantation
Date/Time: Saturday June 24, 2023 at 5:15 PM PT
Authors: Mateusz Ogledzinski, Sarah Gondek, William Lin, Kamila Milejczyk, Braden Juengel, Lisa Potter, Piotr
K. Bachul, Lindsay Basto, Laurencia Perea, Lingjia Wang, Martin Tibudan, Rolf Barth, John Fung, Piotr
Witkowski
Sernova will disclose additional information about the presentation at the time of the conference in alignment
with the American Diabetes Association’s abstract embargo policies, which lift at the conclusion of the
presentation on June 24, 2023. All abstracts are preliminary until the time of presentation.
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 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.
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Press Release Communiqué de presse - March 14, 2023 14 March, 2023
Sernova Announces Upcoming Podium Presentation of iPSC and Cell Pouch™ Combination Treatment for Type One Diabetes at the 4th IPITA / HSCI / JDRF Summit
- First pre-clinical data presentation of Sernova’s Cell Pouch with Evotec’s iPSC derived islet-like cluster
technology for type 1 diabetes (T1D)
LONDON, Ontario – March 14, 2023 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-
stage company and leader in cell therapeutics, announced today that an abstract has been selected for an oral
presentation at the 4th International Pancreas and Islet Transplant Association (IPITA) / Harvard Stem Cell
Institute (HSCI) / Juvenile Diabetes Research Fund (JDRF) Summit, to be held from April 24-25, 2023 in
Cambridge, Massachusetts. The presentation will be given by Matthias Austen, PhD, SVP Cell Therapy at
Evotec SE (FSE:EVT; NASDAQ:EVO).
Abstract Title: Manufacturing of optimized human islet-like clusters (ILCs) from iPSCs and functional testing of
an ILC + Cell Pouch™ combination in vivo
Authors: Audrey Holtzinger, Simone Strauch, Thomas Reinbothe, Claudia Wrzos, Andreas Scheel, Cord
Dohrmann, Arash Memarnejadian, Pardis Pakshir, Philip M. Toleikis, Matthias Austen
Date / Time: Monday, April 24, 2023 from 2:45pm-4:25pm ET
Evotec has developed a scalable and comprehensive process for GMP manufacturing of ILCs from a human
GMP-grade induced pluripotent stem cell (iPSC) line for cell therapy treatment of insulin-dependent diabetes.
In 2022, Evotec entered into a collaboration with Sernova Corp., which has developed the proprietary Cell
Pouch System™. Following implantation, the Cell Pouch develops a vascularized environment to support
engraftment and long-term function of therapeutic cells.
Sernova will disclose additional information about the presentation at the time of the conference.
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 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.
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Press Release Communiqué de presse - March 08, 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.
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Press Release Communiqué de presse - March 02, 2023 2 March, 2023
Sernova to Participate in Upcoming Roth and Oppenheimer Investor Conferences
-Sernova provides warrant update
LONDON, Ontario – March 2, 2023 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-
stage company and leader in cell therapeutics, today announced it will be participating in the upcoming 35th
Annual Roth Conference being held March 12-14, 2023 and the Oppenheimer 33rd Annual Healthcare
Conference, taking place March 13-15, 2023. Company management will also be participating in one-on-one
investor meetings at the conferences.
35th Annual Roth Conference – March 12-14, 2023
Format: Fireside Chat
Date: 4:00PM PT, March 13, 2023
Participant: Dr. Philip Toleikis, President & CEO, Sernova Corp
Location: The Ritz Carlton, Laguna Niguel in Dana Point, California
Webcast Link: https://wsw.com/webcast/roth46/sva/1689510
Oppenheimer Virtual 33rd Annual Healthcare Conference – March 13-15, 2023
Format: Corporate Presentation
Date & Time: 2:00PM ET, March 14, 2023
Participant: Dr. Philip Toleikis, President & CEO, Sernova Corp
Location: Virtual
Webcast Link: https://wsw.com/webcast/oppenheimer27/sva/2565906*
*A replay will be available on the Investors section of Sernova’s website for 90 days.
Please contact your representative at either Roth or Oppenheimer to schedule a one-on-one meeting with the
management team during the conference.
Sernova also announced that 20,136,918 warrants, issued at the time of its previous financing in March 2021,
expired unexercised on March 1, 2023. Total shares outstanding in the Company stands at 303,332,686. There
are no outstanding warrants remaining in Sernova’s capital structure.
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.
Share the news Partagez les nouvelles
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.
Share the news Partagez les nouvelles
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.
Contact Us Contactez-nous
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Development
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Dr. Philip Toleikis
Sernova Corp.
1.519.858.5184
info@sernova.com
Corporate Communications, Investor Relations and Media Relations Communications d'entreprise, relations avec les investisseurs et relations avec les médias
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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