Kenneth R. Chien, M.D., Ph.D. of the Karolinska Institutet
Kenneth R. Chien, M.D., Ph.D. of the Karolinska Institutet

AstraZeneca will develop novel cardiovascular and catheter-based therapies using Procella Therapeutics’ stem cell technology and Smartwise’s catheter injection method, it was disclosed today, through a collaboration that could generate up to $320 million-plus for the parent company of the pharma giant’s partners.

Procella and Smartwise are wholly owned subsidiaries of SWIB Holdings, which announced the collaboration. SWIB Holdings is the holding company of Swedish Innovation Bridge Company (SWIBCo), a biotech and medical device investment company based in Stockholm.

The companies have signed a strategic research collaboration and commercialization agreement launching the collaboration. It aims to use the SWIBCo companies’ technologies to help develop new stem cell–based therapies to repair parts of the heart that have been damaged by a heart attack.

The stem cell technology was developed at the Karolinska Institutet by Kenneth R. Chien, M.D., Ph.D., distinguished professor of the Swedish Research Council and director of the Wallenberg-Karolinska Cardiovascular Initiative. His lab focuses on heart development at the molecular and cellular levels: “Our research group plans to provide new insight into several areas of human cardiogenesis, ranging from molecular decoding of human heart development to developing completely novel technologies to control gene expression in the intact heart in vivo.”

Dr. Chien is among six inventors listed on patent application US20170240964A1 for which Procella is the current assignee. The application—“Genetic Markers for Engraftment of Human Cardiac Ventricular Progenitor Cells”—was pending as of last year.

“The present invention provides genetic markers for identifying engraftable human cardiac ventricular progenitor cells. The engraftment markers of the invention include angiogenic markers and extracellular matrix markers,” according to the patent application, which in the U.S. has a Priority date of February 19, 2016, and was published on August 24, 2017. The application was published internationally on October 5, 2017, according to the World Intellectual Property Organization (WIPO) Patentscope database.

“Human ventricular progenitor cells expressing these markers are capable of forming ventricular tissue in vivo that is vascularized and supported by an extracellular matrix. Methods of engrafting human cardiac ventricular progenitor cells by transplanting into a subject progenitor cells that express the engraftment markers are also provided,” the application added.

Up to $320M in Milestones

AstraZeneca agreed to pay SWIBCo an undisclosed upfront “access fee” payment, research collaboration costs, up to $320 million in clinical development milestones, and sales-related commercial threshold payments upon commercialization of any therapies.

“We are excited about how this convergence of expertise from AstraZeneca and SWIBCo will help drive an innovative regenerative approach that addresses a critical unmet need in treating cardiovascular disease and, at the same time, supports specialist life sciences innovation in the Nordic region,” said Regina Fritsche-Danielson, Ph.D., VP, cardiovascular, renal and metabolism at AstraZeneca's IMED Biotech Unit.

Cardiovascular, renal, and metabolism treatments together comprise one of AstraZeneca’s four areas of therapeutic focus. The others are oncology; respiratory, inflammation, and autoimmunity; and infection and neuroscience.

Founded in 2015, Smartwise is advancing the Extroducer, a novel vascular microcatheter injection technology developed by a group led by Staffan Holmin, M.D., Ph.D., the Söderberg Professor of Clinical Neuroimaging at Karolinska Institutet.

The Extroducer is designed to deliver therapies to targeted and critical areas of the body, such as the abdominal organs, the heart, and the brain. Extroducer can inject cells and biologic and small-molecule therapies directly into organs, including multiple injections to a single target—”opening the door for improved retention of cell-based and biologic therapy and the repurposing of compounds for greater and safer local effect,” according to the company’s website.

Smartwise says it aims to fill an unmet need in direct cancer tumor injection therapy, enabling the delivery of high-dose, locally targeted therapies, without causing systemic side effects. The direct injection technique can potentially also be used to achieve tissue repair in various diseases, according to the company.

“This collaboration has the potential to pioneer the treatment of heart failure,” declared Jonathan Clarke, M.D., CEO of Procella and Smartwise. “By combining the global excellence of AstraZeneca in novel cardiac regenerative medicine therapy with our scientific expertise, we aim to make this unique therapy accessible to patients around the world.”

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