December 20, 2015 20 December, 2015
Sernova Awarded Europe's Prestigious Horizon 2020 Grant to Fund Development of Cell-based Hemophilia Therapeutic Product into the Clinic
Distinguished European consortium awarded approximately $8.5 Million CAD by the European Commission via its Horizon 2020 Program to partner advanced cell based Factor VIII therapy in collaboration with Sernova and its Cell Pouch(TM) device technologies
December 21, 2015, 6:00 a.m. EDT
LONDON, ONTARIO – (Marketwire – December 21, 2015) – Sernova Corp. (TSX-V: SVA) (OTCQB: SEOVF) (FSE: PSH), a clinical stage regenerative medicine company, announced today that the European Commission's Horizon 2020 program has awarded a Euro 5.6M ($8.5M CAD) grant to a consortium consisting of Sernova Corp and five European academic and private partners to advance development of a GMP clinical grade Factor VIII releasing therapeutic cell product in combination with Sernova's Cell Pouch(TM) for the treatment of severe hemophilia A, a serious genetic bleeding disorder caused by missing or defective factor VIII in the blood stream.
The current market for factor VIII is US$5.0B/year, with a cost of up to US$260,000 per patient each year. Current standard of care involves regular infusions of factor VIII, which achieves normal factor VIII blood levels for only a few hours at a time. The product being developed by the HemAcure consortium will seek to provide constant delivery of Factor VIII to normalize blood levels in an effort to significantly improve the quality of life of patients suffering from hemophilia A.
The product being developed by the HemAcure consortium is expected to be highly disruptive to the current standard of care treatments for hemophilia A. The therapeutic goal of the product is to use the patient's own cells corrected for the factor VIII gene. These cells placed in the implanted Cell Pouch will release factor VIII on a continual basis at a rate that would be expected to significantly reduce disease-associated hemorrhaging and joint damage. The constant delivery of factor VIII is also expected to reduce or eliminate the need for multiple weekly infusions which is the current standard of care using plasma-derived or recombinant, genetically engineered factor VIII for the prophylactic treatment of hemophilia A.
"The therapeutic potential to have a constant release of factor VIII from a hemophilia A patient's own genetically corrected cells placed within the implanted Cell Pouch would be a very significant advance in the treatment of hemophilia A," remarked Dr. David Lillicrap, MD, FRCPC Professor Department of Pathology and Molecular Medicine Queens University, Canada Research Chair in Molecular Hemostasis and member of the HemAcure Scientific Advisory Board. "Sernova's Cell Pouch with its vascularized tissue lined chambers for therapeutic cells, which has already been proven for islet safety and survival in human clinical assessment of diabetes, is an ideal, fully scalable first-in-class medical device suitable for the potential treatment of hemophilia," added Dr. Lillicrap.
"It has been exciting working together with the highly skilled team of experts in the HemAcure consortium in hemophilia and cell therapy. The scientific strength of this consortium was evident from the inception of the idea through the development and awarding of the grant to the stimulating kick off meeting," said Delfina Siroen, Sr. Director of Sernova's Research and Development team. "In a very short time, Sernova's hemophilia program has achieved great strides and the addition of this European grant and team will ensure the best possible outcome for this program to the clinic," continued Ms. Siroen.
The preliminary preclinical proof of concept data used as a basis to support the foundation of the grant was generated in a collaborative agreement between Medicyte GmbH under the FP7 ReLiver project, grant agreement 304961 and Sernova Corp where cryopreserved cells with the ex vivo inserted corrected gene for factor VIII were successfully shipped and assessed in Sernova's Cell Pouch at its headquarters in Canada. Regarding Sernova's participation in the consortium, the review of the HemAcure grant proposal stated the following, "Participation of the third country partner (Sernova Corp) is essential for carrying out the (program). This is justified by the fact that the partner in question is the one who possesses the technology that will be the basis of the whole proposal, and which will perform all the in vivo studies. Sernova uses a scalable, contract manufactured, proprietary patented worldwide implantable medical device (Cell Pouch) transplanted with therapeutic cells. (It) has been in development for more than six years and has shown success in multiple small and large animal preclinical models and is now in a clinical trial for another therapeutic indication. This Cell Pouch device is the only such device that when implanted under the skin is proven to become incorporated with blood vessel enriched tissue-forming chambers for the placement of therapeutic cells. This implies that the Canadian partner (Sernova) is an essential partner for the success of this project."
About Hemophilia A
People with Hemophilia have prolonged abnormal bleeding as a result of trauma. Hemophilia A, also called factor VIII (FVIII) deficiency is the most common form of Hemophilia and is a genetic disorder caused by missing or defective factor VIII, a blood clotting protein. Severe hemophilia occurs in about 60% of cases where the deficiency of Factor VIII is less than 1% of normal blood concentration. While it is passed down from parents to children, about 1/3 of cases are caused by a spontaneous change in the gene. According to the US Centers for Disease Control and Prevention hemophilia occurs in about 1 in 5,000 births. If the prolonged bleeding occurs in the brain of a person with hemophilia, it can be fatal. Prolonged bleeding in joints can cause inflammatory responses and permanent joint damage. Approximately 20,000 people in the United States and 10,000 in Europe have the moderate or severe form of hemophilia A, as well as approximately 2,500 in Canada. All races and ethnic groups are equally affected by hemophilia A. Though there is no cure for the disease, it can be controlled with regular infusions of recombinant clotting Factor VIII. Annual costs for the treatment of the disease for each patient may range from $60,000 to $260,000 US for a total cost of between $2-5B per year in North America and Europe.
About Horizon 2020 Programme
Horizon 2020 is the biggest EU Research and Innovation program ever with nearly Euro 80 billion of funding available over seven years (2014 to 2020). It promises more breakthroughs, discoveries and world-firsts by taking great ideas from the lab to the market. The project is funded as part of societal challenges "personalizing health and care" in a specific call about innovative treatments and technologies. New therapies, such as gene or cell therapies, often require technological innovation in the form of development of specific component tools and techniques such as isolation and multiplication of a cell or development of a scaffold, delivery of the therapy to the patient and for following-up the effect of the therapy in the patient. In particular, achieving therapeutic scale production and GMP standards at reasonable cost is often underestimated. The European Union aims to improve the development of advanced methods and devices for targeted and controlled delivery, and to bring these innovative treatments to the patient.
About HemAcure
HemAcure is the name of the consortium developing a product for hemophilia A. This project has received funding from the European Union's Horizon 2020 research and innovation program under grant agreement No 667421. The consortium members include the University Hospital Wurzburg (Coordinating Institute), Integrierte Management Systeme IMS e.K., Universita del Piemonte Orientale "Amedeo Avogadro," Loughborough University, GABO:mi Gesellschaft für Ablauforganisation: milliarium mbH & Co. and Sernova Corp. The main objective of the HemAcure project is to develop and refine the tools and technologies for a novel ex vivo prepared cell based therapy within Sernova's prevascularized Cell Pouch to treat this bleeding disorder that should ultimately lead to improved quality of life of the patients.
About Sernova
Sernova Corp is a clinical stage regenerative medicine Company developing medical technologies for the treatment of chronic debilitating metabolic diseases such as diabetes, blood disorders including hemophilia and other diseases treated through replacement of proteins or hormones missing or in short supply within the body. Sernova is developing the Cell Pouch(TM), an implantable medical device and therapeutic cells (donor, xenogeneic or stem cell derived therapeutic cells) which then release proteins and/or hormones as required.
Forward Looking Information 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, which include our beliefs about the functionality of the Cell Pouch and our expectations of the potential benefits of the consortium and the Horizon 2020 hemophilia project, are based on the beliefs, estimates and opinions of Sernova's management on the date such statements were made. 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. Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.