Adaptive Phage Therapeutics (APT), announced the U.S. Food and Drug Administration (FDA) has granted the company orphan drug designation for the treatment of prosthetic joint infections (PJI) utilizing PhageBank™. Orphan drug designation is given to drugs and biologics being developed to treat rare medical conditions, specifically those affecting fewer than 200,000 persons in the U.S. Orphan drug designation for the treatment of PJI utilizing PhageBank™ provides eligibility for seven years of U.S market exclusivity upon FDA approval, a waiver from payment of marketing application User Fees, an exemption from performing clinical studies in pediatric patients, and tax credits that reduce the effective cost of progressing related clinical development.
GAITHERSBURG, Md., August 19, 2020 – Adaptive Phage Therapeutics (APT), a clinical-stage biotechnology company dedicated to providing therapies to treat the global rise of bacterial and viral infectious diseases, today announced the Department of Defense (DoD) awarded APT $9.8 million for research development of multiple high-priority, bacteriophage-based display vaccine candidates against the novel coronavirus (SARS-CoV-2). The effort will advance and evaluate vaccine candidates in Phase 1 clinical trials. APT is the only biotechnology company with a phage-based COVID-19 vaccine program projected to enter clinical trials in 2020.
Adaptive Phage Therapeutics (APT), a clinical-stage biotechnology company founded to provide an effective therapeutic response to the global rise of multi-drug resistant (MDR) pathogenic bacteria, today announced Mayo Clinic has committed $1.75M as a lead investor in a $7 million convertible note financing round.
For scientists, clinical trials like these are a first try. For participants, they are often a last hope.
At the brink of giving up, John Haverty turned to internet research. He was aware of phage treatment [the therapeutic use of bacteriophages to treat bacterial infections like Haverty’s], and he happened across Maryland-based Adaptive Phage Therapeutics.
GAITHERSBURG, Md.–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.
Adaptive Phage Therapeutics was featured in an April 28 broadcast in the Netherlands, Dokters van morgen, discussing the treatment of stubborn infections. The discussion regarding APT begins at the 35 minute mark and features John Haverty (a patient helped by APT).
“Never Give Up on Your Life” – John Haverty.
John Haverty is a chef, a family man, a patient who was battling a stubborn bacterial infection in his leg for over 10 years. He wasn’t able to walk and put both feet on the ground for over 10 year. Doctors at Mayo Clinic were about to amputate John’s leg as the last resort until a virus (called Phage Therapy from Adaptive Phage Therapeutics) saved his life.
GAITHERSBURG, Md.–(BUSINESS WIRE)–Adaptive Phage Therapeutics (APT), a clinical-stage biotechnology company founded to provide an effective therapeutic response to the global rise of multi-drug resistant (MDR) pathogenic bacteria, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for the clinical development of PhageBank™, a personalized bacteriophage therapeutic for the treatment of MDR and complicated bacterial infections. The Phase 1/2 trial represents the first study of an expanding phage library under FDA allowance for a multi-site study of intravenous administration and/or bladder instillation of phage therapy. Beginning in Q2, APT will enroll patients at up to three clinical sites for the evaluation of PhageBank for the treatment of complicated and chronic recurrent urinary tract infections (UTIs).