PhageBank Therapeutics

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)

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 three controlled clinical trials in patients with PJI. These studies are funded in part through an investment from the Mayo Clinic and through a collaboration with the University of Maryland.

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 three 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 or Klebsiella pneumoniae. 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
50
0
0
0
Discovery
50
Human Emergency Use
Phase 1/2
0
Pivotal
0
Market
0
Chronic Wound w/Osteomyelitis

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, open-label, repeat-dose, multi-site study 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
0
0
0
Discovery
100
Human Emergency Use
Phase 1/2
0
Pivotal
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Market
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Partner-sponsored (confidential)

PhageBank Companion Diagnostics

DevelopmentEmergency and Trial UseAdvanced DevelopmentCommercial Launch as LDT @ Mayo Clinic LabsMulti-site Market Launch
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100
50
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0
Development
100
Emergency and Trial Use
100
Advanced Development
50
Commercial Launch as LDT @ Mayo Clinic Labs
0
Multi-site Market Launch
0
HRQT Phage Susceptibility Test

Mayo Clinic and APT are collaborating to advance and commercialize a phage susceptibility test (PST) linked exclusively to APT’s PhageBank™. 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.

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
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Discovery
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Preclinical
100
Phase 1/2
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Market
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COVID-19 Vaccine

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

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’s in-licensing partners for epitopes and constructs include the Navel Medical Research Center (NMRC), Biological Defense Research Directorate (BDRD), and EpiVax, Inc.

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.