Press release Communiqué de presse
Press release Communiqué de presse
March 15, 2021 15 March, 2021
Sernova Provides Positive Outlook Regarding the Development of Its Innovative Therapeutics Platform Technology for Chronic Diseases
Sernova is the first and only regenerative medicine therapeutics platform company to demonstrate a well-
vascularized subcutaneous islet transplant technology achieving persistent islet graft function in diabetic
Sernova CEO hosting an investor conference call on March 18, 2021 at 11:00 am (EDT)
March 15, 2021 9:00 a.m. EDT
LONDON, ONTARIO – March 15, 2021 – Sernova Corp. (TSX-V:SVA) (FSE/XETRA:PSH) (OTCQB:SEOVF), a clinical-stage regenerative medicine company, today provides a Corporate Update and highlights recent key achievements in its pipeline, including its diabetes clinical program as well as other leading development programs.
“I am pleased that our clinical study based on our unique technology platform continues to contribute significant advancements to the field of regenerative medicine therapeutics. This is demonstrated by ongoing positive patient outcomes in safety, tolerability, and efficacy measures as we actively approach completion of full study enrolment. These advancements are occurring despite ongoing global uncertainty related to the COVID-19 pandemic. In this restrictive environment, Sernova also achieved significant advancements in our other therapeutic programs and in the development of technologies that we believe are building significant shareholder value and justified optimism for patients suffering from chronic diseases. As validation of our strategic approach, we are pleased with the recently completed institutional led bought deal financing of $23M. We are aggressively moving forward with all of our programs,” said Dr. Philip Toleikis, President and CEO of Sernova.
DIABETES : SERNOVA’S LEAD CLINICAL INDICATION
Sernova’s principal investigator in its US Phase I/II diabetes clinical trial, Dr. Piotr Witkowski, presented an update at the recent 2021 21st Winter Symposium of the American Society of Transplant Surgeons based on data from its current clinical trial: A Safety, Tolerability and Efficacy -Study of Sernova's Cell Pouch for Clinical Islet Transplantation.
Five of the 7 planned patients have been enrolled, implanted with the Cell Pouch, and are advancing through the transplantation phases of the study.
The following key findings to date have been noted in our trial patients:
• The Primary Safety Endpoint of the study continues to be met:
o the Cell Pouch, following implantation under the skin, shows consistent incorporation with vascularized tissue in multiple patients providing a suitable environment for the survival and function of insulin producing cells; and
o the implanted Cell Pouch and therapeutic cells continue to demonstrate a positive safety profile with no serious adverse events related to the Cell Pouch.
• The Secondary Efficacy measures continue to show clinical benefit in the most advanced treated patients including:
o absence of life-threatening hypoglycemic episodes;
o enduring presence of insulin produced by the Cell Pouch transplanted cells (measured by the biomarker C- peptide) in the bloodstream;
o reduction or elimination in the daily amount of insulin injected; and
o a reduction in HbA1c, a measure of long-term blood sugar control, which can lead to reduced diabetic complications.
Pre-screening of the final two patients is actively underway to complete study enrollment.
Sernova as a member of the Horizon 2020 HemAcure Consortium (HemAcure Consortium) presented results of the Consortium’s research at the American Society of Gene and Cell Therapy. Importantly, the following highlights were presented:
• hemophilia A patients unable to express the required clotting factor VIII (FVIII) blood cells were isolated;
• the human FVIII gene responsible for the production of the missing required clotting factor was successfully inserted to achieve a therapeutic effect;
• the safety of these newly corrected cells and their ability to produce sufficient human clotting factor both in laboratory and in an initial preclinical animal model was confirmed.
o human FVIII blood levels reached up to 10%, which is considered sufficient to enable patients to regain their clotting ability;
o these corrected therapeutic cells in the Cell Pouch were successfully assessed in a preclinical model of hemophilia A showing long-term survival of cells;
o human FVIII was also detected in the bloodstream long-term (measured up to four months, the length of the study, following treatment); and
• data further confirmed functional clotting improvement in the blood at the four months time point where human FVIII corrected cells transplanted into the hemophilia A preclinical model restored the animals clotting activity to a therapeutic level within the Cell Pouch.
“These results demonstrate the success in developing a novel approach for the treatment of hemophilia A. These results continue to showcase Sernova’s Cell Pouch platform technologies for the treatment of multiple indications including rare diseases where a gene can be inserted into cells to produce any protein or factor required to treat disease,” added Toleikis. “We look forward to completing work to bring this and other novel therapies to human clinical testing as soon as practicable.”
Sernova is developing a treatment for hypothyroid disease following complete or partial removal of the thyroid gland (thyroidectomy). To advance this platform technology, in collaboration with Dr. Sam Wiseman and in part funded by a Transplant Venture Grant awarded by the Transplant Research Foundation (TRF) of British Columbia, we are assessing healthy human thyroid tissue in preparation of a clinical program.
This new treatment approach allows patients to preserve their thyroid function following a thyroidectomy by transplanting healthy thyroid cells into Sernova’s Cell Pouch. Currently completed pre-clinical work is setting the stage for a regulatory submission for this second clinical program.
PLATFORM EXPANDING TECHNOLOGIES AND CORPORATE COLLABORATIONS
Sernova is acquiring and developing state of the art technologies. These involve both unique cell encapsulating technologies and gene editing technologies to reduce or eliminate the need for immunosuppression medications targeted to our specific cell therapy clinical applications within the Cell Pouch platform.
• Sernova has acquired all the patented technology and knowhow for a cellular local immune protection technology (Conformal Coating Technology)
o an exclusive worldwide license agreement with the University of Miami was signed, broadening this technology scope.
o Sernova intends on bringing the Cell Pouch platform technologies, which includes conformally coated therapeutic cell technology, to the clinic first for our diabetes donor and stem cell programs with the goal to improve current cell therapy treatment options.
• Sernova also entered into a collaboration agreement with AgeX Therapeutics to utilize their UniverCyte™ technology. The objective is to generate transplantable genetically engineered stem cells that are immune protected to treat diseases for use in Sernova’s Cell Pouch.
Sernova is in active collaborations with leading global pharmaceutical companies for multiple cell therapy clinical applications in combination with Sernova’s cell therapy therapeutic platform and technologies. The goal of these collaborations is to initiate co-development and/or licensing agreements, as well as the potential ability to market and distribute our regenerative medicine therapeutics worldwide.
Dr. Toleikis will participate in the first of a series of conference calls for shareholders to provide corporate updates and answer questions at 11:00 am (EDT) on March 18, 2021. A presentation will be made available on Sernova’s website before the call. All questions to Dr. Toleikis can be submitted to email@example.com prior to the call. To participate in this live conference call, please visit:
Meeting link: https://sernovacorp.my.webex.com/sernovacorp.my/j.php?MTID=md016888548d385cd4fea3878b73a9b5d Meeting number: 182 490 4245 Password: SVAMarch2021 (78262724 from phones and video systems)
Join by phone +1-416-915-6528 CANADA TOLL +1-415-655-0001 US TOLL Access code: 182 490 4245 (Global call-in numbers available upon request)
Following the conference call a recording will be available at www.sernova.com
ABOUT SERNOVA CORP.
Sernova Corp is developing regenerative medicine therapeutic technologies using a medical device and immune protected therapeutic cells (i.e. human donor cells, corrected human cells and stem-cell-derived cells) to improve the treatment and quality of life of people with chronic metabolic diseases such as insulin-dependent diabetes, blood disorders including hemophilia, and other diseases treated through replacement of proteins or hormones missing or in short supply within the body. For more information, please visit www.sernova.com
For further information, please contact: Dominic Gray Sernova Corp Tel: (519) 858-5126 firstname.lastname@example.org www.sernova.com
This release may contain forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words “expects”, “plans”, “anticipates”, “believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or conditions “will”, “would”, “may”, “could” or “should” occur. Although Sernova believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance, and actual results may differ materially from those in forward-looking statements. Forward-looking statements are based on the beliefs, estimates, and opinions of Sernova’s management on the date such statements were made, which include our beliefs about the conduct and outcome of clinical trials. 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.