Press release Communiqué de presse
Press release Communiqué de presse
October 1, 2021 1 October, 2021
Sernova: The Ultimate Combination of Two Proven Technologies as Potential Functional Cure for Type1 Diabetes and Other Chronic Diseases
Information Session Webinar on Sernova’s Conformal Coating Immune Protection Technology with Dr. Toleikis
and International Expert, Dr. Tomei Now Available on Sernova’s Website
October 1, 2021 6:00 a.m. EDT
LONDON, ONTARIO – October 1, 2021 – Sernova Corp. (TSX-V:SVA)(OTCQB:SEOVF) (FSE/XETRA:PSH), a leading clinical-stage regenerative medicine company developing a ‘functional cure’ for type 1 diabetes (T1D) and other chronic diseases, recently hosted an information session webinar. The webinar announced Sernova’s collaboration with the University of Miami (UMiami) and associate professor and international expert in immunoprotection and diabetes engineering, Dr. Alice Tomei of the UMiami’s Diabetes Research Institute. During this webinar Drs. Toleikis and Tomei discussed the Conformal Coating Immunoprotection Technology and its pivotal role within Sernova’s Cell Pouch Technology platform. A Q&A session followed the presentation by Drs. Toleikis and Tomei. The responses to key questions asked by attendees are summarized below.
For those investors and other interest parties who were unable to attend the information session, a recording is available at www.sernova.com
At what stage of development is the Conformal Coating Immunoprotection Technology?
This technology is backed by over 12 years of scientific research. Scientific research has included extensive preclinical testing followed by optimization to arrive at the final formulation which is being tested in Sernova’s Cell Pouch.
Have islets with Conformal Coating been shown to be safe in preclinical models?
Yes. A positive safety profile has been demonstrated in small and large animal preclinical models.
Does the Conformal Coating affect the release of insulin from islets tested in the lab?
Insulin release in conformal coated islets is comparable to uncoated islets. Conformal coated islets have shown uptake of glucose and the release of insulin remains normal.
When tested in preclinical models of diabetes, is the release of insulin into the bloodstream from islets with Conformal Coating similar to uncoated islets?
Preclinical diabetes studies completed have shown a normal insulin response to a glucose challenge (glucose tolerance test).
Have conformal coated islets been shown to provide a ‘functional cure’ for diabetes in preclinical models?
Yes. In two preclinical diabetes animal model studies completed, long-term insulin independence without the need for immunosuppressive drugs has been demonstrated which is considered to be a ‘functional cure’.
Have stem cell derived islets with Conformal Coating been shown to provide a ‘functional cure’ for diabetes in preclinical models?
Yes. Long-term insulin independence has been demonstrated.
It seems the Conformal Coating and Cell Pouch technologies have both been tested and optimized. Do you expect that the combination of these two technologies will enable more rapid entry into the clinic than if developing new technologies?
Yes. We are combining these two well tested technologies in our studies with the goal of entering clinical trials for both donor islets and diabetes stem cell technologies as soon as practicable.
Why is the Conformal Coating approach for immune protection ideally suited for the Sernova’s Cell Pouch technologies?
We believe the Cell Pouch design provides the ideal organ-like environment for therapeutic cells. Our ability to provide Conformal Coating immunoprotection of cells within the Cell Pouches vascularized, organ-like environment could avoid the detrimental issues associated with other immune protected macro devices, while providing a protected and retrievable site for the therapeutic cells. This combination is expected to form a platform for multiple therapeutic cell technologies.
From an investor viewpoint, why is this collaboration important?
The opportunity to provide patients with a locally immune protected cell therapy treatment approach without the need to take life-long immunosuppression medications is expected to dramatically increase the available patient populations for multiple diseases who could benefit from these therapies. In addition, locally immune protected cells within the Cell Pouch is of great interest to our pharmaceutical collaborators. The ultimate combination of two proven technologies as a potential ‘functional cure’ for T1D and other chronic diseases would be expected to add tremendous shareholder value from the expansion of addressable markets across multiple indications, and in turn, potential long term revenues.
Dr. Toleikis, President & CEO of Sernova, stated, “In the development of a novel therapeutic cell therapy approach for all people with T1D, Sernova’s systematic approach has provided encouraging initial safety and clinical benefit in patients with brittle T1D. We continue to take a leadership role with our unique local cellular immunoprotection strategies for islet technologies and look forward to the day when patients can enjoy a ‘functional cure’ without the need for life-long immunosuppression drugs.”
Sernova is developing regenerative medicine therapeutic solutions using a medical device (Cell Pouch™) and immune protected therapeutic cells/tissues (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 cellular production of proteins or hormones missing or in short supply within the body. For more information, please visit www.sernova.com.
ABOUT SERNOVA’S CELL POUCH SYSTEM
The Cell Pouch, as part of the Cell Pouch System, is a novel, proprietary, scalable, implantable macro- encapsulation device solution designed for the long-term survival and function of therapeutic cells. The device upon implantation is designed to incorporate with tissue, forming highly vascularized tissue chambers for the transplantation and function of therapeutic cells, which then release proteins and hormones as required to treat disease.
The Cell Pouch, along with therapeutic cells, has been shown to provide long-term safety and efficacy in small and large animal models of diabetes and has been proven to provide a biologically compatible environment for insulin-producing cells in humans in a Canadian first-in-human study. Sernova is currently conducting a Phase I/II study at the University of Chicago. Positive initial results have been presented at several international scientific conferences.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Investors: Corey Davis, Ph.D. LifeScience Advisors, LLC firstname.lastname@example.org 212-915-2577
Corporate: Investor Relations Sernova Corp. Tel: (519) 858-5126 email@example.com www.sernova.com
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.