— Assay to rapidly match therapeutic phage to antibiotic-resistant infections —
June 09, 2020 09:00 AM Eastern Daylight Time
GAITHERSBURG, Md.–(BUSINESS WIRE)–Mayo Clinic and Adaptive Phage Therapeutics (APT) today announced a collaboration to advance and commercialize a phage susceptibility test (PST) linked exclusively to APT’s PhageBank™ investigational therapy. At launch, the PST will be offered as a laboratory developed test for worldwide commercial availability by Mayo Clinic Laboratories (MCL). The PST will enable rapid identification of patient-specific precision therapy for challenging bacterial infections, including, but not limited to, those that are antimicrobial resistant (AMR) or complicated with biofilms.
The phage susceptibility test is being developed to simultaneously test hundreds of phage candidates selected from APT’s PhageBank, against bacteria isolated from a patient. The PST will identify one or more phage that may be deployed to treat the infection.
“One of the most difficult lessons we are all learning from the COVID-19 pandemic is that pharmaceutical approaches need to be able to rapidly adapt to new and more virulent diseases and infections,” said Greg Merril, chief executive officer and co-founder, Adaptive Phage Therapeutics. “Our PhageBank investigational therapy, made from an ever-expanding and diverse collection of therapeutic agents, combined with susceptibility testing, will allow for a rapid, precise and adaptive approach to dealing with infectious diseases. Our ability to adapt to emerging resistance is the key to combat these diseases in a long-term, durable therapeutic way. The problem of antibiotic resistance will continue to grow as bacteria continue to evolve. PhageBank is designed to adapt to change and therefore remains effective as bacteria continue to evolve.”
“We have now treated several patients with PhageBank under FDA emergency allowance. In each of these cases, APT successfully matched its investigational PhageBank therapy to bacteria we isolated from patients suffering advanced and chronic prosthetic joint infections,” said Gina A. Suh, M.D., Infectious Disease expert at Mayo Clinic.
Working closely with Mayo Clinic Laboratories, Adaptive Phage Therapeutics will have an opportunity to accelerate worldwide access to PhageBank therapy. “At Mayo Clinic, we have put significant effort into developing strategies to overcome antibacterial resistance, and we are pleased to collaborate with Adaptive Phage Therapeutics,” said Robin Patel, MD, Chair of the Division of Clinical Microbiology and Director of the Infectious Diseases Research Laboratory, Mayo Clinic.
Mayo Clinic, Dr. Patel and Dr. Suh have a financial interest in the technology referenced in this news release. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education and research.
About Antimicrobial Resistance (AMR)
According to the Centers for Disease Control, more than 2.8 million antibiotic-resistant infections occur in the United States each year, and more than 35,000 people die as a result.1 The World Health Organization estimates that superbugs will kill up to 10 million people globally each year by 2050.2 Thirty-five percent of common human bacterial infections are already resistant to currently available medicines in some high-income countries.3
According to the World Health Organization, there is a US $100 trillion potential cost in terms of lost global production between now and 2050.4 The indirect costs of drug-resistant infections to the individual and society from morbidity, disability, premature deaths and reduced effective labor supply are estimated to cause a decrease in the global economic output of 1–3% by 2030, with estimated losses ranging from US $1 trillion to US $3.4 trillion annually if no action is taken.5
Bacterial biofilms are densely packed communities of microbial cells that grow on living or inert surfaces and surround themselves with secreted polymers. Biofilms have significance for public health because biofilm-associated microorganisms exhibit decreased susceptibility to many antimicrobial agents. Many bloodstream infections and urinary tract infections are associated with indwelling medical devices and, therefore, (in most cases) biofilm-associated.7 In American hospitals alone, thousands of deaths are attributed to biofilm-related surgical site infections and urinary tract infections.6
Bacteriophage (“phage”) are viruses that host on bacteria. Phage have evolved to become the most prolific killers of bacteria on earth. Phage have been used for clinical applications since their initial discovery at the beginning of the twentieth century. The ability of phage to replicate exponentially and kill bacteria suggests that they could play a vital role in our armamentarium for the treatment of infectious diseases.8 There are an estimated 10 phage for each bacteria on earth, and each phage strain has evolved to eradicate a narrow range of bacteria. The introduction of penicillin in the 1940s displaced interest in commercial development of phage. With the growing crisis of bacterial resistance to antibiotics, there has been renewed interest in phage therapy.
PhageBank is an ever-expanding collection of genetically diverse, carefully screened, and purified phage that are collectively broad spectrum, negating the effects of bacterial resistance that increasingly diminish the effectiveness of antibiotics. In 2017, APT acquired world-wide exclusive commercial rights to PhageBank from the biodefense program of the U.S. Department of Defense. APT is advancing the technology through innovation in bioinformatics, rapid phage-bacteria matching and phage purification methods in an approach capable of providing a precision-matched therapy based upon the diagnosis of a specific bacterial pathogen.
About Adaptive Phage Therapeutics (APT)
APT is a clinical-stage company founded to provide an effective therapeutic response to the global rise of multi-drug resistant (MDR) pathogenic bacteria. APT’s core asset is a large and continually expanding phage library (PhageBank™) deployed with a companion diagnostic to achieve rapid response and cost-effective therapy for otherwise recalcitrant bacterial infections. The technology was developed by the biodefense program of U.S. Department of Defense. APT acquired the world-wide exclusive commercial rights in 2017. Under the FDA emergency Investigational New Drug (eIND) allowance, APT has provided investigational PhageBank therapy to treat more than 23 critically ill patients in which standard-of-care antibiotics had failed. For more information, visit http://www.aphage.com.
8 The prospect for bacteriophage therapy in Western medicine. Merril, Scholl, Adhya -Nature Reviews Drug Discovery, 2003
For Adaptive Phage Therapeutics