C3J Therapeutics
Clinical-stage biotechnology company developing pathogen-specific bacteriophage therapeutics using phage discovery, synthetic biology engineering, in‑house formulation and cGMP manufacturing, and clinical development to address antibiotic-resistant and difficult-to-treat bacterial infections.
Industries
Nr. of Employees
small (1-50)
C3J Therapeutics
5005 McConnell Ave, Los Angeles, CA 90066, USA
Patents
Dental strips for the delivery of specifically targeted antimicrobial peptides
US-11707431-B2
View DetailsDental varnishes that release specifically targeted antimicrobial peptides and/or fluoride
US-11633341-B2
View Details
Dental strips for the delivery of specifically targeted antimicrobial peptides
US-11707431-B2
View DetailsDental varnishes that release specifically targeted antimicrobial peptides and/or fluoride
US-11633341-B2
View DetailsProducts
Inhaled phage cocktail for chronic Pseudomonas aeruginosa pulmonary infection (clinical-stage)
Sterile liquid phage cocktail formulated for nebulized inhalation to treat chronic pulmonary Pseudomonas aeruginosa infections (including cystic fibrosis and bronchiectasis). Clinical program includes completed Phase 1b/2a (SWARM-P.a.) and a Phase 2 study (Tailwind) demonstrating favorable safety and reductions in sputum P. aeruginosa colony-forming units in pooled analyses.
Intravenous phage cocktail for Staphylococcus aureus bacteremia (clinical-stage)
Natural lytic phage cocktail developed for treatment of complicated Staphylococcus aureus bacteremia and related infections; evaluated in randomized Phase 1b/2a trials with reported topline results.
Phage cocktail candidate for acute hospitalized pneumonia (preclinical/early development)
Phage cocktail program targeting acute hospital-acquired and ventilator-associated Pseudomonas aeruginosa pneumonia informed by an internal clinical isolate collection and phage screening efforts; intended for acute inpatient indications.
Inhaled phage cocktail for chronic Pseudomonas aeruginosa pulmonary infection (clinical-stage)
Sterile liquid phage cocktail formulated for nebulized inhalation to treat chronic pulmonary Pseudomonas aeruginosa infections (including cystic fibrosis and bronchiectasis). Clinical program includes completed Phase 1b/2a (SWARM-P.a.) and a Phase 2 study (Tailwind) demonstrating favorable safety and reductions in sputum P. aeruginosa colony-forming units in pooled analyses.
Intravenous phage cocktail for Staphylococcus aureus bacteremia (clinical-stage)
Natural lytic phage cocktail developed for treatment of complicated Staphylococcus aureus bacteremia and related infections; evaluated in randomized Phase 1b/2a trials with reported topline results.
Phage cocktail candidate for acute hospitalized pneumonia (preclinical/early development)
Phage cocktail program targeting acute hospital-acquired and ventilator-associated Pseudomonas aeruginosa pneumonia informed by an internal clinical isolate collection and phage screening efforts; intended for acute inpatient indications.
Services
End-to-end discovery, genomic analysis, synthetic engineering and preclinical evaluation of bacteriophage candidates targeting multidrug-resistant bacterial pathogens.
Production, purification, stability testing and release of sterile clinical trial material manufactured under cGMP with associated QC/QA systems.
Management and conduct of randomized, controlled clinical studies including protocol design, site oversight, pharmacokinetic assessments and independent efficacy adjudication.
Case-by-case review process for expanded access requests including assessment of patient eligibility, manufacturing capacity and regulatory/ethics requirements.
End-to-end discovery, genomic analysis, synthetic engineering and preclinical evaluation of bacteriophage candidates targeting multidrug-resistant bacterial pathogens.
Production, purification, stability testing and release of sterile clinical trial material manufactured under cGMP with associated QC/QA systems.
Management and conduct of randomized, controlled clinical studies including protocol design, site oversight, pharmacokinetic assessments and independent efficacy adjudication.
Case-by-case review process for expanded access requests including assessment of patient eligibility, manufacturing capacity and regulatory/ethics requirements.
Expertise Areas
- Bacteriophage discovery and engineering
- Preclinical pharmacology, biofilm and toxicology assay development
- Pulmonary delivery and lung pharmacokinetics for inhaled biologics
- cGMP biologics manufacturing and quality systems
Key Technologies
- Next-generation sequencing (NGS)
- Comparative genomics and bioinformatics pipelines
- Synthetic biology and genome engineering
- High-throughput phage library screening and phenotyping
News & Updates
Completed SWARM-P.a. Phase 1b/2a study reported AP-PA02 was well tolerated with pharmacokinetics showing effective lung delivery by nebulization, minimal systemic exposure, and signals of decreased sputum Pseudomonas aeruginosa levels versus placebo.
Awarded funding from a disease-focused foundation to support development and clinical evaluation of inhaled phage therapy for cystic fibrosis patients with Pseudomonas aeruginosa infection.
Completed Phase 2 Tailwind study in non-cystic fibrosis bronchiectasis reported durable reductions in sputum Pseudomonas aeruginosa CFUs in pooled analyses, favorable safety and tolerability, and persistence of bacterial load reduction up to two weeks post-dosing.
Completed enrollment and last patient last visit for a Phase 1b/2a randomized, double-blind, placebo-controlled study of an intravenous Staphylococcus aureus phage cocktail.
Award funding administered by a U.S. Department of Defense consortium to support ongoing clinical trial activity for an investigational intravenous bacteriophage product for Staphylococcus aureus bacteremia.
Reported statistically significant improvement in investigator-assessed responder rate at test-of-cure and additional supportive analyses from a Phase 1b/2a study of an intravenous Staphylococcus aureus phage cocktail.
Completed SWARM-P.a. Phase 1b/2a study reported AP-PA02 was well tolerated with pharmacokinetics showing effective lung delivery by nebulization, minimal systemic exposure, and signals of decreased sputum Pseudomonas aeruginosa levels versus placebo.
Awarded funding from a disease-focused foundation to support development and clinical evaluation of inhaled phage therapy for cystic fibrosis patients with Pseudomonas aeruginosa infection.
Completed Phase 2 Tailwind study in non-cystic fibrosis bronchiectasis reported durable reductions in sputum Pseudomonas aeruginosa CFUs in pooled analyses, favorable safety and tolerability, and persistence of bacterial load reduction up to two weeks post-dosing.
Completed enrollment and last patient last visit for a Phase 1b/2a randomized, double-blind, placebo-controlled study of an intravenous Staphylococcus aureus phage cocktail.
Award funding administered by a U.S. Department of Defense consortium to support ongoing clinical trial activity for an investigational intravenous bacteriophage product for Staphylococcus aureus bacteremia.
Reported statistically significant improvement in investigator-assessed responder rate at test-of-cure and additional supportive analyses from a Phase 1b/2a study of an intravenous Staphylococcus aureus phage cocktail.