(TheNewswire)
LONDON, ONTARIO – TheNewswire - January 20, 2022 – Sernova Corp. (TSXV:SVA)(OTC:SEOVF) (FSE/XETRA:PSH), a clinical-stage regenerative medicineand cell therapy therapeutics company developing a potential‘functional cure’ for chronic diseases is pleased to announce apeer reviewed published scientific journal article highlightingsuccessful development of a novel cell therapy approach for treatmentof severe hemophilia A , a serious genetic bleeding disorder caused bymissing factor VIII (FVIII) activity in the blood stream.
The journal article entitled “Efficient and SafeCorrection of Hemophilia A by Lentiviral Vector-Transduced BOECs in anImplantable device (Sernova’s Cell Pouch ™ ),” was published in theprestigious scientific journal, Molecular Therapy: Methods &Clinical Development, Volume 23, December 2021.
The therapeutic approach includes use of thepatient’s own cells obtained from a blood sample, which are thenmodified using a lentiviral vector-mediated gene transfer procedureusing the B-domain deleted form of FVIII under the control of anendothelial-specific promoter and subsequently transplanted withinSernova’s vascularized Cell Pouch into a mouse model of hemophiliaA. These cells then provide a continuous therapeutic release of factorVIII into the bloodstream. The publication highlights that theHemAcure Consortium has now successfully demonstrated safety andlong-term improvement in blood clotting in a hemophilia A mouse model.
It is estimated that 115,000 people live withhemophilia A in North America and Europe with a significant proportionwho rely on regular infusions of FVIII. Treatment costs per patientare as high as US $200,000 each year, with an aggregate therapeuticcost of over US$ 10 billion per year.
“This novel ex vivo gene therapy approach is thefirst demonstration showing the safety and feasibility oftransplantation of lentiviral-corrected blood outgrowth endothelialcells (BOECs) within an implantable medical device using GMP-likeprocedures for the long-term treatment of hemophilia A,” said thelead author Dr. Antonia Follenzi, MD, PhD, Professor, Department ofHealth Sciences, School of Medicine, Università del PiemonteOrientale. “If this therapy is successful in future clinical trials,it could become an important new therapeutic approach to improve thequality of life for people suffering with severe hemophiliaA.”
Dr. Philip Toleikis, President and CEO Sernova Corpstated, “This publication representsapproximately four years of dedicated work by the HemAcure consortium,from conceptualizing this novel treatment approach, through tovalidating its potential as a safe and long-term treatment option forpeople with hemophilia A. The Sernova Cell Pouch provides the requiredenvironment for transplanted cells to survive and function in thebody, as demonstrated by the production of FVIII to improve bloodclotting as reported by Dr. Follenzi and colleagues.” He continued,“We recognizes ex vivo gene therapy as a potential therapeuticoption for people suffering from multiple rare diseases and we areproud that our technologies may contribute to the development andfuture delivery of functional cures for these ailments.”
The HemAcure consortium research was supported byfunding from the European Commission’s Horizon 2020.
ABOUT HEMOPHILIA A
Hemophilia A is the most common form of hemophilia andis a genetic disorder caused by the reduced or absence of FVIII, ablood clotting protein. People with hemophilia A have prolongedabnormal bleeding as a result of trauma or surgery. While it is passeddown from parents to children, about 1/3 of cases are caused by aspontaneous change in the gene responsible for FVIII production.According to the US Centers for Disease Control and Prevention,hemophilia A occurs in about 1 in 5,000 male births. Prolongedbleeding in high-risk areas such as the brain can be catastrophic,while persistent bleeding in joints results in permanent damage makingjoint replacement surgery common and risky procedures among thesepatients. Approximately 115,000 people in North America and Europehave hemophilia A. Although there is no cure for the disease,hemophilia A can be controlled with medications to supplement orreplace the missing FVIII. Annual worldwide costs for the treatmentof the disease for each patient may range from $60,000 to $260,000 USfor an aggregate therapeutic cost of approximately $15B peryear.
ABOUT SERNOVA
Sernova is developing regenerative medicine therapeuticsolutions using a medical device (Cell Pouch) and immune protectedtherapeutic cells / tissues (i.e. human donor cells, corrected humancells and stem cell-derived cells) to improve the treatment andquality of life of people with chronic metabolic diseases such asinsulin-dependent diabetes, blood disorders including hemophilia, andother diseases treated through cellular production of proteins orhormones missing or in short supply within the body. For moreinformation, 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.
ABOUT HORIZON 2020 PROGRAM ANDHEMACURE
Horizon 2020 was the biggest EU Research and Innovationprogram ever with nearly €80 billion of funding available over sevenyears (2014 to 2020). It promised more breakthroughs, discoveries andworld-firsts by taking great ideas from the lab to the market. Theproject was funded as part of societal challenges “personalizinghealth and care” in a specific call about innovative treatments andtechnologies. The overall objective of the HemAcure project was todevelop and refine the tools and technologies for a novel ex vivoprepared cell-based therapy to treat the bleeding disease, hemophiliaA (caused by a genetic deficiency in clotting Factor VIII (FVIII))that should ultimately lead to improved quality of life of thepatients. The European Union's Horizon 2020 research and innovationprogram awarded approximately €5.5 million (CDN$8.5) to support theproject. International consortium membersincluded the University Hospital Würzburg (Coordinating Institute),Germany; IMS - Integrierte Management, Heppenheim, Germany;Università del Piemonte Orientale “Amedeo Avogadro,” Novara,Italy; Loughborough University, Loughborough, United Kingdom; ARTTICInternational Management Services, Munich, Germany and Sernova Corp.,London, Ontario, Canada. This project receivedfunding from the European Union’s Horizon 2020 Research andInnovation Programme under grant agreement No 667421. The Consortium worked together to provide sets of design andmanufacturing protocols, based on current European GMP regulations toprepare an Investigational Medicinal Product Dossier (IMPD) for anInvestigational Medicinal Product (IMP), composed of therapeutic cellsand an implantable medical device (Sernova’s Cell Pouch).
FOR FURTHER INFORMATION, PLEASECONTACT:
Christopher Barnes
VP, Investor Relations
Sernova Corp.
christopher.barnes@sernova.com
Tel: 519-902-7923
Corey Davis, Ph.D.
LifeScience Advisors, LLC
Tel: 212-915-2577
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 additional information on risks and uncertaintiesrelating to the forward-looking statements. Sernova expressly disclaims any intention or obligation to update orrevise any forward-looking statements, whether as a result of newinformation, future events or otherwise.
Copyright (c) 2022 TheNewswire - All rights reserved.