Press release Communiqué de presse
Press release Communiqué de presse
September 16, 2021 16 September, 2021
Sernova Signs Collaboration Agreement to Advance Conformal Coated Immune Protected Therapeutic Cells for Diabetes with the University of Miami
Collaboration to build on positive Cell Pouch T1D Clinical Outcomes and preclinical success in Global
Pharmaceutical Collaborations to develop regenerative medicine therapeutic cures without life-long
immunosuppression medications across multiple diseases
An information session featuring Dr. Alice Tomei, a leading international expert in immunoprotection and diabetes immunoengineering at the University of Miami, will take place on September 20th, 2021, at 1:00 PM EDT
September 16, 2021 6:00 a.m. EDT
LONDON, ONTARIO – September 16, 2021 – Sernova Corp. (TSX-V:SVA)(OTCQB:SEOVF)(FSE/XETRA:PSH), a clinical-stage regenerative medicine company developing a ‘functional cure’ for type 1 diabetes (T1D) and other chronic diseases, announced today it has entered into a research agreement with the University of Miami to advance the development of our Cell Pouch™ cell therapy platform combined with the novel conformal coating cellular immune protection technology.
Dr. Alice Tomei, of the renowned Diabetes Research Institute (DRI) at the University of Miami Miller School of Medicine, is an associate professor and international expert in immunoprotection and diabetes immunoengineering. As part of this important collaboration, Dr. Tomei and her team is working closely with Sernova’s R&D team. The expert teams have developed a series of key preclinical and polymer characterization studies. In addition, work is being conducted to scale-up the conformal coating technology process. The ultimate goal of this work is to support and accelerate the anticipated clinical evaluation of the Cell Pouch platform without the need for immunosuppression in patients with brittle T1D.
While the studies will focus on immune protection of insulin producing cells in the Cell Pouch, these technology advances are expected to be directly relevant and applicable to an array of cell technologies for treatment of multiple cell therapy applications.
Dr. Tomei stated, “We have developed and optimized the conformal coating technologies over approximately twelve years with the goal of ensuring local immune protection of therapeutic cells without the need for life- long immunosuppression medications. Our hope is that Sernova’s Cell Pouch technologies, which have already shown initial clinical benefit in patients with brittle T1D, when combined with conformally coated local immune protected islets, have the potential to provide a significant advancement in the treatment of people suffering from T1D.”
Dr. Toleikis, President & CEO of Sernova stated, “In our development of a therapeutic cell therapy approach for all people with T1D, we have used a systematic and stepwise strategy, first by combining our Cell Pouch in the clinic for patients with brittle T1D with human donor islets protected with immunosuppression. Given the proven safety and efficacy of our Cell Pouch technologies, we are now thrilled to take this next step in our strategic approach by collaborating with Dr. Tomei’s team to advance the conformal coating as a cellular local immune protection strategy for islet technologies.”
“An information session will take place on September 20th, 2021, at 1:00 PM EDT. The information session will feature Dr. Alice Tomei, associate professor at the University of Miami. During this information session, Dr. Tomei will discuss the conformal coating technology approach for local cellular immune protection and Sernova will also provide a management update during this session," said Dr. Philip Toleikis, "Session attendees will be able to ask questions during a following Q&A period with Dr. Tomei and Sernova management.”
The presentation will be made available on Sernova's website before the call. Questions can be submitted to email@example.com prior to the call.
To register and access the Zoom link for this event, please click: https://us02web.zoom.us/webinar/register/WN_iDuWzqW4R3COgQ_toI376A
Following the event, a recording will be available at www.sernova.com.
ABOUT SERNOVA Sernova Corp 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: Investor Relations Sernova Corp. Tel: (519) 858-5126 firstname.lastname@example.org www.sernova.com
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.