PhageBank Therapeutics

DiscoveryHuman Emergency UsePhase 1/2PivotalMarket
100
33
0
0
Discovery
100
Human Emergency Use
Phase 1/2
33
Pivotal
0
Market
0
Diabetic Foot Osteomyelitis (DFO)

DFO is commonly associated with diabetic foot infections and is associated with significant morbidity and mortality. Failure of the infection to resolve and the ulcer to heal, ultimately leads to amputation of the affected limb. Avoiding amputation is a major goal when treating DFO. The limited effectiveness of antibiotics in the treatment of DFOs is multifactorial. The presence of biofilm and/or vascular insufficiency at the site of infection and the presence of antibiotic resistant bacteria play a role. Phage therapy, in addition to SOC antibiotics, has demonstrated wound closure and healing of DFOs as well as reossification of affected bone [Fish 2016].

APT has seen clinical proof points for APT’s PhageBank and companion diagnostic technology in the treatment of infections related to chronic wounds including involvement of osteomyelitis under FDA emergency Investigational New Drug (eIND) allowance.

APT.DFI.001 is a randomized, double-blind, placebo-controlled, repeat-dose, multi-site trial investigating the safety, tolerability, and efficacy of personalized phage treatment and standard of care in patients with diabetic foot infections due to Staphylococcus aureus. This effort is funded in part through an advanced development contract with the U.S. Defense Health Agency.

DiscoveryHuman Emergency UsePhase 1/2PivotalMarket
100
33
0
0
Discovery
100
Human Emergency Use
Phase 1/2
33
Pivotal
0
Market
0
Prosthetic Joint Infection (PJI)

Prosthetic Joint Infections (PJI) is a serious complication of joint replacement surgery. Estimates are that approximately 0.5% to 2% of knee prostheses and 0.3% to 1.7% of hip prostheses will become infected over the life of the implant (Zimmerli 2014). The financial burden is staggering; the overall cost to the healthcare system in the US for treating PJI is estimated to exceed $1.62 billion (Kurtz et al 2012). In general, treatment of recalcitrant PJI is limited to the use of two-stage exchange arthroplasty and indefinite chronic oral suppressive antibiotic therapy (SAT), oral SAT without further surgical intervention, arthrodesis, or amputation (Tande and Patel 2014). All of these options have significant life-altering ramifications.

APT has seen several clinical proof points for APT’s PhageBank therapy and phage susceptibility companion diagnostic technology in the treatment of Prosthetic Joint Infections (PJI) and related infections (e.g. osteomyelitis and biofilm-related implanted device infections) under FDA emergency Investigational New Drug (eIND) allowance.

Currently, APT is sponsoring the development of two clinical trials in patients with chronic PJI. These studies are funded in part through an investment from the Mayo Clinic and through collaborations with the University of Maryland and other institutions.

DiscoveryHuman Emergency UsePhase 1/2PivotalMarket
100
33
0
0
Discovery
100
Human Emergency Use
Phase 1/2
33
Pivotal
0
Market
0
Chronic Recurrent UTI

APT has seen clinical proof points for APT’s PhageBank and companion diagnostic technology in the treatment of Urinary Tract Infections (UTI) under FDA emergency Investigational New Drug (eIND) allowance.

APT.UTI.001 is a phase I/II adaptive trial that is being conducted at nine clinical sites in the United States. This trial is designed to evaluate the safety and efficacy of PhageBank therapy in patients with urinary tract infections due to Escherichia coli. This effort is funded in part through an advanced development contract with the U.S. Defense Health Agency.

Link: clinicaltrials.gov

DiscoveryHuman Emergency UsePhase 1/2PivotalMarket
55
0
0
0
Discovery
55
Human Emergency Use
Phase 1/2
0
Pivotal
0
Market
0
Ophthalmic Infection

APT has partnered with Oyster Point (NASDAQ: OYST) in a research collaboration to develop potentially novel therapies to treat bacterial infections in ophthalmology using bacteriophages.

DiscoveryHuman Emergency UsePhase 1/2PivotalMarket
100
33
0
0
Discovery
100
Human Emergency Use
Phase 1/2
33
Pivotal
0
Market
0
Cystic Fibrosis-related Lung Infection

APT has seen clinical proof points for APT’s PhageBank and companion diagnostic technology in the treatment of lung infections due to Pseudomonas aeruginosa associated with cystic fibrosis under FDA emergency Investigational New Drug (eIND) allowance.

APT, in an agreement with the Antibacterial Resistance Leadership Group (ARLG) and the National Institutes of Health (NIH) National Institute of Allergies and Infectious Disease (NIAID), is supporting a Phase 1b/2, multi-centered, randomized, double-blind, placebo-controlled trial assessing the safety and microbiological activity of a single dose of bacteriophage therapy in cystic fibrosis subjects colonized with Pseudomonas aeruginosa. Under the agreement, APT is providing phage strains acquired under a license from The Walter Reed Army Institute of Research (WRAIR).

PhageBank Companion Diagnostics

DevelopmentEmergency and Trial UseAdvanced DevelopmentCommercial Launch as LDT @ Mayo Clinic LabsMulti-site Market Launch
100
100
66
0
0
Development
100
Emergency and Trial Use
100
Advanced Development
66
Commercial Launch as LDT @ Mayo Clinic Labs
0
Multi-site Market Launch
0
PhageBank Susceptibility Test (PST)™

APT’s PST serves as a companion diagnostic to PhageBank and allows for real-time surveillance of resistant bacterial strains as they emerge. Mayo Clinic and APT are collaborating to advance and commercialize PST. At commercial launch, the PST will be offered as a laboratory developed test (LDT) for worldwide availability by Mayo Clinic Laboratories (MCL). The PST will enable rapid identification of patient-specific precision therapy for challenging bacterial infections, including those that are antimicrobial resistant (AMR) or complicated with biofilms.

The phage susceptibility test is being developed to simultaneously screen hundreds of phage candidates selected from APT’s PhageBank against bacteria isolated from patients. The PST will identify one or more phage that may be deployed to treat these infections.

Mayo Clinic has a financial interest in the technology referenced. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education and research.

This effort is also funded in part through an advanced development contract with the U.S. Defense Health Agency.

APT Vaccines

DiscoveryPreclinicalPhase 1/2PivotalMarket
100
100
0
0
0
Discovery
100
Preclinical
100
Phase 1/2
0
Pivotal
0
Market
0
COVID-19 Vaccine

APT’s vaccine candidates are based on de-activated phage nanoparticles that are engineered to express epitopes of SARS-CoV2.

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.

APT.COV.001 is a randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, tolerability, and immunogenicity of multiple bacteriophage-based SARS-CoV-2 vaccine candidates in healthy adult participants. Vaccines will be administered via an intramuscular injection and a sublingual substrate. This effort is funded in part through an advanced development contract with the U.S. Defense Health Agency.