About Adaptive Phage Therapeutics

Company Story

In 2003, as multi-drug resistant (MDR) bacteria was starting to pose a serious international health risk, National Institutes of Health (NIH) scientist Carl R. Merril, MD, published a pivotal article that outlined prior limitations of phage therapy and suggested concepts that have emerged as the modern approach. In 2010, the Biological Defense Research Directorate (BDRD) of the US Navy began an initiative to explore Dr. Merril’s concepts as a potential way to deal with biodefense threats associated with MDR superbugs. In 2016 this approach achieved a significant milestone with the successful rescue of Tom Patterson, a critically ill A. baumannii infected patient. Tom Patterson’s case was immediately followed by numerous additional patient cases. In response for the need to translate the Navy’s phage research into a commercially available therapy, Adaptive Phage Therapeutics (APT) was founded by Dr. Merril and his son Greg Merril. The company acquired world-wide exclusive rights to BDRD’s phage technology and began efforts to optimize precision phage therapy for rapid, cost effective, clinical adoption.

Greg Merril CEO & Co-Founder Founding CEO for three prior VC-backed fast growth health and medical product companies. He has led over 20 corporate financing transactions cumulatively raising over $100 million. At HT Medical Systems he led the company to become one of Maryland's fastest growth technology firms for four consecutive years and completed a $42M merger with Immersion Corp. Inventor with 19 issued patents. Recognized as a TEDMED Innovation Scholar and as Regional Ernst & Young Entrepreneur of the Year ('07). He was a Founder, CEO & Chair, of Brain Sentry, Inc. (2011-2015); Founder, CEO & Chair, Interaction Laboratories, Inc. (2002-2009); Founder, CEO & Chair, Immersion Medical, Inc. (NASDQ: IMMR) (1987 - 2002). Carl R. Merril, MD CSO & Co-Founder Internationally recognized expert in phage. Emeritus Scientist at the National Institutes of Health (NIH) with more than 200 scientific papers published and nearly two dozen patents. Recipient of numerous United States Public Health Service awards including the Outstanding Service Medal for "leadership in the development of new biochemical methods for the investigation of human diseases," a Distinguished Service Medal for "outstanding contributions to the health of the nation," and the Surgeon General's Medallion for "outstanding leadership, exemplary performance, and extraordinary support to the Office of the Surgeon General." Subhendu Basu, PhD COO Established leader in biotech industry having headed Scientific Affairs at Emergent BioSolutions Inc. Responsible for technical diligence for all acquisition and in-licensing activities leading to M&A in excess of $1B that resulted in the addition of 10 marketed products and multiple pipeline assets, that included vaccines, therapeutics and drug-device combination products. Earned his PhD in Immunology and Pathology from the University of Maryland, School of Medicine and was Assistant Professor at the Center for Vaccine Development prior to transitioning to biopharma. Leadership Robert J. Hopkins, MD, MPH & TM, FACP, FIDSA Vice President, Clinical Development Established leader in clinical development having served as Team Leader in the Division of Special Pathogens and Immunologic Drug Products, FDA and as Senior Advisor at the Biomedical Advance Research and Development Authority (BARDA). Over 20 years of experience in clinical and product development of infectious disease products at Merck Research Labs, DynPort Vaccine Company, Emergent BioSolutions and Aeras. Served on multiple NIH study sections and as a reviewer for multiple scientific journals in the area of infectious disease. Michael Brownstein, MD, PhD CMO Scientist Emeritus at the NIH. Served as the Chief of the Laboratory of Genetics of the National Institute of Mental Health and the National Human Genome Research Institute in addition to two years as Scientific Director of the NIMH Intramural Research Program at the NIH. He has directed research projects at the NIMH/NHGRI and J. Craig Venter Institute (Rockville, MD). Published in over 200 papers in peer reviewed journals; served, and continues to serve, on editorial boards and scientific advisory boards. He has also been involved in the founding of several successful biotech companies. Leadership George Church, PhD Professor at Harvard & MIT, co-author of 490 papers, 130 patent publications & the book “ egenesis”, developed methods used for the first genome sequence (1994) & million-fold cost reductions since (via NGS and nanopores), plus barcoding, DNA assembly from chips, genome editing, writing & recoding. He co-initiated the BRAIN Initiative (2011) & Genome Projects (1984, 2005) to provide & interpret the world’s only open-access personal precision medicine datasets. Tom Patterson, PhD Conducted research in a number of areas including HIV/AIDS prevention, rehabilitation of older patients with psychosis, and stress responses of caregivers of Alzheimer’s disease patients. Authored or co-authored over 400 scholarly papers, 17 book chapters, and a widely-used textbook on human behavior. A founding editor of the journal AIDS and Behavior and served as co-editor and on the editorial boards of a number of other journals. In March 2016, Tom Patterson, became the first known person in the United States to successfully undergo intravenous bacteriophage (phage) therapy. Steffanie Strathdee, PhD Associate Dean of Global Health Sciences and Harold Simon Professor in the Department of Medicine at the University of California San Diego (UCSD) School of Medicine. Also, an Adjunct Professor at the Johns Hopkins and Simon Fraser Universities. Infectious disease epidemiologist with a focus on HIV prevention in developing countries, especially among marginalized populations. Published in over 550 peer-reviewed publications addressing issues including HIV prevention and the history of HIV. Currently leading several NIH-funded studies of HIV risk behaviors among at-risk populations on the Mexico-US border. Scientific Advisory Board Michele Wales, PhD, JD Founder and principal of InHouse Patent Counsel. Previously Department Head of Litigation and Intellectual Property at Human Genome Science (HGS); created and managed all aspects of HGS’ IP portfolio in the US and internationally. Additionally, participated in the drug development process of multiple lead clinical candidates and was involved in bringing HGS’ first approved drug to market. Before receiving her JD, held position of honors scholar in Molecular and Cellular Biology at the University of Connecticut. This was followed by her earning her PhD in Human Genetics and Molecular Biology from Johns Hopkins Medical School. Robert "Chip" Schooley, MD, FIDSA Professor of Medicine, Department of Medicine, Division of Infectious Diseases and Global Public Health, at the University of California San Diego (UCSD). Former Head of the Division of Infectious Diseases, UCSD. Served as Chair of the NIAID’s AIDS Clinical Trials Group (ACTG), where he expanded research sites leading to the establishment of the ACTG as the largest and most productive group of its kind (clinical and translational research organization examining parthenogenesis and complications of therapy as they relate to HIV. Scientific Advisory Board

GMP Manufacturing

In September 2017, APT opened state-of-the-art BSL2 labs and phage manufacturing facilities designed to FDA GMP ICH Q7A and ISO Class 8 standards. This is the only facility of its kind specifically focused on rapid and precise delivery of phage therapy. APT’s facility is strategically located in Gaithersburg, Maryland – within 50 miles of FDA, BDRD, NMRC, Walter Reed Military Hospital, Johns Hopkins, and NIH. APT’s facilities are unique as they were designed from the ground up specifically for manufacturing patient specific therapeutic phage products. The facility includes a dedicated clean room and separate phage amplification and purification lab that is built to GMP and GLP guidelines. There is an extensive set of standard operating procedures: for the use, cleaning, and validation of equipment; the purchase, tracking, and storage of supplies; and for training personnel.

 

APT’s aseptic fill/finish facilities have been designed to overcome the biggest challenges related to our phage therapy approach. A typical drug compound (a small molecule or a biologic) with standard production techniques will take multiple days to set up and complete a fill process. APT’s PhageBank™ includes hundreds of different phage so traditional manufacturing would require years to complete inventory to support the clinical trials and longer to complete inventory for commercialization. That is unacceptable, so APT has made a significant investment in a state-of-the-art, first of its kind, automated aseptic fill system that automates 6-log decontamination between batches. This innovative system allows APT to fill up to three different batches per day per fill room and can be further scaled up as required.

 

Scientific & Business Collaborators

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