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Research Triangle Park, N.C. – January 12, 2021 – Asklepios BioPharmaceutical, Inc. (AskBio), a clinical-stage adeno-associated virus (AAV) gene therapy company and wholly owned subsidiary of Bayer AG, today announced that Katherine High, MD, has joined the company in the newly formed role of President, Therapeutics and will also serve on its Board of Directors. She will be responsible for driving the strategic direction and execution of the company’s preclinical and clinical programs.
“It is with great pleasure that we welcome Dr. High to AskBio,” said Sheila Mikhail, AskBio Co-founder and CEO. “She is a seasoned leader who led the team that achieved the first FDA approval for a gene therapy for a genetic disease, as well as an accomplished hematologist whose pioneering bench-to-bedside studies helped characterize the human immune response to AAV vectors in a variety of target tissues. We are thrilled Dr. High is now bringing her unique leadership and insights to our team.”
Dr. High stated, “In looking to the future of the field, I have been impressed with AskBio’s innovative, flexible and high-yield manufacturing capabilities and their inventive use of capsid engineering to expand therapeutic possibilities for AAV. Dr. Jude Samulski has been a long-time leader in molecular virology, manufacturing and engineering of AAV. Decades ago, I received the first set of reagents I used to make recombinant AAV at the benchtop from him, and I expect that our mutual interests and complementary areas of expertise within AAV gene therapy will be a powerful engine for continuing, and even accelerating, progress at AskBio. I look forward to joining AskBio and the growing family of cell and gene therapy companies within the Bayer organization.”
Dr. Samulski, Co-founder and Chief Scientific Officer of AskBio noted, “Dr. High’s many ‘firsts’ in clinical gene therapy, her longstanding commitment to the field, and her innovative approaches to solving problems in AAV therapeutics, make her an ideal addition to AskBio’s leadership team. We believe she will use her experience in gene therapy drug development to help advance the company’s existing pipeline and identify new indications in the areas of genetic and complex acquired disorders.”
Most recently, Dr. High was a Visiting Professor at Rockefeller University. Previously, she served as President, Head of Research and Development, and a member of the board of directors at Spark Therapeutics, where she directed the development and regulatory approval of Luxturna®, the first gene therapy for a genetic disease to obtain regulatory approval in both the United States and Europe. She was a longtime member of the faculty at the University of Pennsylvania and the medical staff at The Children's Hospital of Philadelphia, where she was also an Investigator of the Howard Hughes Medical Institute. She served a five-year term on the U.S. Food and Drug Administration Advisory Committee on Cell, Tissue and Gene Therapies and is a past president of the American Society of Gene & Cell Therapy.
Dr. High received her bachelor’s degree in chemistry from Harvard University, a medical degree from the University of North Carolina School of Medicine, a business certification from the University of North Carolina Business School’s Management Institute for Hospital Administrators and a master’s degree from the University of Pennsylvania. She is an elected member of the National Academy of Medicine, the American Academy of Arts and Sciences, and the faculty of Pharmaceutical Medicine of the Royal College of Physicians (London).
Asklepios BioPharmaceutical, Inc. (AskBio), a wholly owned and independently operated subsidiary of Bayer AG acquired in 2020, is a fully integrated AAV gene therapy company dedicated to developing life-saving medicines that cure genetic diseases. The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular and metabolic disease indications with a clinical-stage pipeline that includes therapeutics for Pompe disease, Parkinson’s disease and congestive heart failure, as well as out-licensed clinical indications for hemophilia and Duchenne muscular dystrophy. AskBio’s gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive AAV capsid and promoter library. With global headquarters in Research Triangle Park, North Carolina, and European headquarters in Edinburgh, UK, the company has generated hundreds of proprietary third-generation AAV capsids and promoters, several of which have entered clinical testing. Founded in 2001 and an early innovator in the gene therapy field, the company holds more than 500 patents in areas such as AAV production and chimeric and self-complementary capsids. Learn more at www.askbio.com or follow us on LinkedIn.
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to benefit people by supporting efforts to overcome the major challenges presented by a growing and aging global population. At the same time, the Group aims to increase its earning power and create value through innovation and growth. Bayer is committed to the principles of sustainable development, and the Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2019, the Group employed around 104,000 people and had sales of 43.5 billion euros. Capital expenditures amounted to 2.9 billion euros, R&D expenses to 5.3 billion euros. For more information, visit www.bayer.com.
Robin Fastenau, phone +1 984.275.2705
Vice President, Communications
This press release contains "forward-looking statements." Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "will," "intends," "potential," "possible" and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements regarding AskBio’s pipeline of development candidates; AskBio’s goal of developing life-saving medicines aimed at curing genetic diseases; the potential benefits of AskBio’s development candidates to patients; and Dr. High being well-positioned to help advance AskBio’s therapeutic strategy.
These forward-looking statements involve risks and uncertainties, many of which are beyond AskBio’s control. Known risks include, among others: AskBio may not be able to execute on its business plans and goals, including meeting its expected or planned regulatory milestones and timelines, clinical development plans and bringing its product candidates to market, due to a variety of reasons, including the ongoing COVID-19 pandemic, possible limitations of company financial and other resources, manufacturing limitations that may not be anticipated or resolved in a timely manner, potential disagreements or other issues with our third-party collaborators and partners, and regulatory, court or agency feedback or decisions, such as feedback and decisions from the United States Food and Drug Administration or the United States Patent and Trademark Office.
Any of the foregoing risks could materially and adversely affect AskBio’s business and results of operations. You should not place undue reliance on the forward-looking statements contained in this press release. AskBio does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof.