Overview

CF-301 is a bacteriophage-derived lysin with potent activity against Staphylococcus aureus (“Staph aureus”) bloodstream infections. CF-301 is the first and only lysin to enter human clinical trials in the US and has recently completed a Phase 1 trial in healthy volunteers. This compound is being developed for the treatment of Staph aureus bloodstream infections (BSI; bacteremia), including endocarditis, caused by methicillin-resistant and susceptible Staph aureus (MRSA and MSSA) strains. New drug-resistant strains of Staph aureus have been identified which demonstrate resistance against vancomycin and daptomycin, the only two standard-of-care (SOC) antibiotics indicated for the treatment of MRSA BSI in the US. CF-301 has the potential to be a first-in-class, new treatment for Staph aureus bacteremia. CF-301 has specific and rapid bactericidal activity against Staph aureus. Combinations of CF-301 with vancomycin or daptomycin increased survival significantly in animal models of disease when compared to treatment with SOC antibiotics or CF-301 alone. CF-301 targets a highly conserved region of the cell wall that is vital to bacteria, thus making resistance less likely to develop. When used in combination with SOC antibiotics, the result is a novel combination therapy that has the potential to combat the high unmet clinical need of Staph aureus infections.

Advantages

  • Combination with antibiotics offers a superior treatment approach based on animal models
  • Act at least 12x faster than current antibiotics
  • Specifically kills Staph aureus and spares good bacteria
  • Clears biofilms

CF-301 Vs. Biofilms

Biofilms act as armor for bacteria by coating their surface and preventing antibiotics from killing them. Biofilms are produced by pathogenic bacteria and can be formed on heart valves, catheters and prosthetic devices. Biofilms also contain bacterial cells which are dormant, and therefore aren’t affected by antibiotics that require bacterial metabolism for their activity. Treatment of biofilm infections can take months of intense antibiotic therapy, and often the only “cure” for a biofilm infection is surgical removal of the material on which it forms, such as the removal of an infected catheter or even the removal of an infected pacemaker, hip or knee. There are currently no products indicated for the treatment of biofilms.

CF-301: Biofilm Removal from Catheter Surface

Eradicate 1

MRSA biofilm infected catheter

Eradicate 2

CF-301: 30 Seconds: Biofilm eradicated

Eradicate 1

CF-301: 15 Minutes: Catheter sterilized

Market Need

Staph aureus bloodstream infections occur in both hospital and community settings, causing an estimated 119,000 hospitalizations and 30,000 deaths each year in the U.S. Drug-resistant strains of Staph aureus such as MRSA have now been reported to exhibit resistance to standard-of-care antibiotics (e.g. vancomycin and daptomycin). New agents are necessary to address this emerging threat, which may ultimately result in infections for which no available therapies are effective. CF-301 has the potential to address this potential therapeutic gap as this phage-derived lysin acts by a unique mechanism and has exhibited microbiologic activity against all resistant strains of Staph aureus in in vitro experiments.

~120,000

Annual Cases of Staph Bacteremia In the U.S.

30,000

Cases in the U.S. That Result in Death

Clinical Summary

CF-301 is the first bacteriophage-derived lysin to enter clinical development in the US. The clinical development program will investigate CF-301, in combination with approved anti-staphylococcal agents, for the treatment of Staph aureus bloodstream infections, including endocarditis, caused by methicillin-susceptible and methicillin-resistant bacteria.

View

Antibody Candidate: CF-404

CF-404 is a monoclonal antibody cocktail for the treatment of influenza

View CF-404 »
View

Technology

Our lysin and monoclonal antibody products represent new, potentially game-changing approaches to treating infections, including those caused by drug resistant pathogens.

Learn More »