(TheNewswire)
InformationSession Webinar on Sernova’s Conformal Coating Immune ProtectionTechnology with Dr. Toleikis and International Expert, Dr. Tomei NowAvailable on Sernova’s Website
L ondon, Ontario - TheNewswire- October 1, 2021 - Sernova Corp.(TSXV:SVA)(OTC:SEOVF) (FSE/XETRA:PSH), a leading clinical-stageregenerative medicine company developing a ‘functional cure’ fortype 1 diabetes (T1D) and other chronic diseases, recently hosted aninformation session webinar. The webinar announced Sernova’scollaboration with the University of Miami (UMiami) and associateprofessor and international expert in immunoprotection and diabetesengineering, Dr. Alice Tomei of the UMiami’s Diabetes ResearchInstitute. During this webinar Drs. Toleikis and Tomei discussed the Conformal Coating Immunoprotection Technology and its pivotal rolewithin Sernova’s Cell Pouch Technology platform. A Q&A session followed the presentation by Drs. Toleikisand Tomei. The responses to key questions asked by attendees aresummarized below.
For those investors and other interest parties who wereunable to attend the information session, arecording is available at www.sernova.com
At what stage of development is theConformal Coating Immunoprotection Technology?
This technology is backed by over 12 years ofscientific research. Scientific research has included extensivepreclinical testing followed by optimization to arrive at the finalformulation which is being tested in Sernova’s Cell Pouch.
Have islets with Conformal Coatingbeen shown to be safe in preclinical models?
Yes. A positive safety profile has been demonstrated insmall and large animal preclinical models.
Does the Conformal Coating affect therelease of insulin from islets tested in the lab?
Insulin release in conformal coated islets iscomparable to uncoated islets. Conformal coated islets have shownuptake of glucose and the release of insulin remains normal.
When tested in preclinical models ofdiabetes, is the release of insulin into the bloodstream from isletswith Conformal Coating similar to uncoated islets?
Preclinical diabetes studies completed have shown anormal insulin response to a glucose challenge (glucose tolerancetest).
Have conformal coated islets beenshown to provide a ‘functional cure’ for diabetes in preclinicalmodels?
Yes. In two preclinical diabetes animal model studiescompleted, long-term insulin independence without the need forimmunosuppressive drugs has been demonstrated which is considered tobe a ‘functional cure’.
Have stem cell derived islets withConformal Coating been shown to provide a ‘functional cure’ fordiabetes in preclinical models?
Yes. Long-term insulin independence has beendemonstrated.
It seems the Conformal Coating andCell Pouch technologies have both been tested and optimized. Do youexpect that the combination of these two technologies will enable morerapid entry into the clinic than if developing newtechnologies?
Yes. We are combining these two well testedtechnologies in our studies with the goal of entering clinical trialsfor both donor islets and diabetes stem cell technologies as soon aspracticable.
Why is the Conformal Coating approachfor immune protection ideally suited for the Sernova’s Cell Pouchtechnologies?
We believe the Cell Pouch design provides the idealorgan-like environment for therapeutic cells. Our ability to provideConformal Coating immunoprotection of cells within the Cell Pouchesvascularized, organ-like environment could avoid the detrimentalissues associated with other immune protected macro devices, whileproviding a protected and retrievable site for the therapeutic cells.This combination is expected to form a platform for multipletherapeutic cell technologies.
From an investor viewpoint, why isthis collaboration important?
The opportunity to provide patients with a locallyimmune protected cell therapy treatment approach without the need totake life-long immunosuppression medications is expected todramatically increase the available patient populations for multiplediseases who could benefit from these therapies. In addition, locallyimmune protected cells within the Cell Pouch is of great interest toour pharmaceutical collaborators. The ultimate combination of twoproven technologies as a potential ‘functional cure’ for T1D andother chronic diseases would be expected to add tremendous shareholdervalue from the expansion of addressable markets across multipleindications, and in turn, potential long term revenues.
Dr. Toleikis, President & CEO of Sernova, stated,“In the development of a novel therapeutic cell therapy approach forall people with T1D, Sernova’s systematic approach has providedencouraging initial safety and clinical benefit in patients withbrittle T1D. We continue to take a leadership role with our uniquelocal cellular immunoprotection strategies for islet technologies andlook forward to the day when patients can enjoy a ‘functionalcure’ without the need for life-long immunosuppression drugs.”
ABOUT SERNOVA
Sernova is developing regenerative medicine therapeuticsolutions using a medical device (Cell Pouch™) and immuneprotected therapeutic cells/tissues (i.e., human donor cells,corrected human cells and stem cell-derived cells) to improve thetreatment and quality of life of people with chronic metabolicdiseases such as insulin-dependent diabetes, blood disorders includinghemophilia, and other diseases treated through cellular production ofproteins or hormones missing or in short supply within the body. Formore information, please visit www.sernova.com .
ABOUT SERNOVA’S CELL POUCHSYSTEM
The Cell Pouch, as part of the Cell Pouch System, is anovel, proprietary, scalable, implantable macro- encapsulation devicesolution designed for the long-term survival and function oftherapeutic cells. The device upon implantation is designed toincorporate with tissue, forming highly vascularized tissue chambersfor the transplantation and function of therapeutic cells, which thenrelease proteins and hormones as required to treat disease.
The Cell Pouch, along with therapeutic cells, has beenshown to provide long-term safety and efficacy in small and largeanimal models of diabetes and has been proven to provide abiologically compatible environment for insulin-producing cells inhumans in a Canadian first-in-human study. Sernova is currentlyconducting a Phase I/II study at the University of Chicago. Positiveinitial results have been presented at several internationalscientific conferences.
FOR FURTHER INFORMATION, PLEASECONTACT:
Investors:
Corey Davis, Ph.D.
LifeScience Advisors, LLC
212-915-2577
Corporate:
Investor Relations Sernova Corp.
Tel: (519) 858-5126
investor.relations@sernova.com
FORWARD-LOOKING INFORMATION
This release contains statements that, to the extentthey 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 thecompany. Wherever possible, but not always, words such as"expects", "plans", "anticipates","believes", "intends", "estimates","projects", "potential for" and similarexpressions, or that events or conditions "will","would", "may", "could" or"should" occur are used to identify forward-lookingstatements. These statements reflect management’s beliefs withrespect to future events and are based on information currentlyavailable to management on the date such statements were made. Manyfactors could cause Sernova’s actual results, performances orachievements to not be as anticipated, estimated or intended or todiffer materially from those expressed or implied by theforward-looking statements contained in this news release. Suchfactors could include, but are not limited to, the company’s abilityto secure additional financing and licensing arrangements onreasonable terms, or at all; ability to conduct all requiredpreclinical and clinical studies for the company’s Cell Pouch Systemand/or related technologies, including the timing and results of thosetrials; ability to obtain all necessary regulatory approvals, or on atimely basis; ability to in-license additional complementarytechnologies; ability to execute its business strategy andsuccessfully compete in the market; and the inherent risks associatedwith 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. Investorsshould consult the company’s quarterly and annual filings availableon www.sedar.com for additionalinformation on risks and uncertainties relating to the forward-lookingstatements. Sernova expressly disclaims any intention or obligation toupdate or revise any forward-looking statements, whether as a resultof new information, future events or otherwise.
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