At Adaptive Phage Therapeutics, our mission is to save lives or restore patient health by developing safe, effective, and durable antimicrobial therapeutics. We harness the diversity and specificity of curated bacteriophages to advance sustainable and accessible treatments that adapt to maintain effectiveness against the emergence of resistant bacterial pathogens.
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.
Today, APT is a clinical-stage biotech advancing therapies to treat multi-drug resistant infections. Prior approaches in antimicrobials have been ‘fixed’ while the pathogens continue to evolve resistance – therefore all have either become obsolete or are becoming obsolete due to antimicrobial resistance. APT’s phage bank approach leverages an ever-expanding library of phages that collectively provide evergreen broad spectrum and polymicrobial coverage. APT’s phage bank therapy is matched through a proprietary phage susceptibility assay that APT has teamed with Mayo Clinic Laboratories to commercialize on a global scale.
APT’s phage bank is positioned to be the first antimicrobial to increase in spectrum of coverage and does not require market-suppressing antibiotic stewardship. Advanced development of APT’s therapeutics are funded in part by the US Dept of Defense.
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 phage bank 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.
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