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.
Phage-based vaccines offer significant potential benefits by establishing a platform approach with the ability to quickly adjust the vaccine in response to mutations in the coronavirus. Additionally, phage-based vaccines are self-adjuvanted, meaning they automatically activate and boost immune response, with the ability to display multiple antigens. The therapeutic use of phage in humans is well understood and has a favorable safety profile.
“A vaccine against COVID-19 will be a critical enabler to protect our service members and the American people,” said Thomas Dunn, Acting Program Manager, Naval Advanced Medical Development, Naval Medical Research Center. “This research contract will expedite prospective efforts to deliver a safe and effective phage-vaccine.”
Recent data suggests that immunity to SARS-CoV2 may be transient and require frequent booster vaccinations to maintain protective levels of immunity. APT is exploring the potential for an oral delivery system in the form of a lozenge for the vaccine and any necessary booster doses.
Forthcoming Phase 1 Clinical Trials
“We anticipate Phase 1 trials to demonstrate safety and immunogenicity,” said Greg Merril, CEO and co-founder, Adaptive Phage Therapeutics. “The potential benefits of a phage-based vaccine include versatility for route of administration (mucosal and intramuscular), including a potential oral lozenge, adaptability to virus mutations, speed of development and cost-effectiveness. These benefits, along with the established safety profile of phage, offer hope as a potential tool in mitigating this terrible pandemic. Additionally, we have the capacity to rapidly scale up production in the continental United States. We are fully committed to deploying our facilities and our staff to fight the impact of this public health crisis.”
If phase 1 trials demonstrate success, APT anticipates future contracts to advance the vaccine through Phase 3 studies and approval.
Adaptive Phage Therapeutics, Inc. (APT) is a clinical-stage company founded to provide an effective therapeutic response to the global rise of multidrug 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 20 critically ill patients in which standard-of-care antibiotics had failed. The company was founded in 2017.