SNIPR Biome has achieved a significant clinical milestone by dosing the first patient in its Phase 1b trial of SNIPR001, marking the first time a CRISPR-armed phage therapy has been administered to cancer patients. The Danish biotech company's innovative approach targets fluoroquinolone-resistant E. coli infections in hematological cancer patients undergoing hematopoietic stem cell transplantation (HSCT).
Novel CRISPR-Phage Technology Addresses Critical Clinical Need
SNIPR001 represents a breakthrough in precision medicine, combining four engineered bacteriophages known as CRISPR-CAS armed phages (CAPs) that specifically target fluoroquinolone-resistant E. coli in the gut microbiome. The therapy was developed through systematic screening of 162 wild-type phages against 429 phylogenetically diverse E. coli strains, followed by sophisticated engineering that incorporates both tail fiber modifications and CRISPR-CAS machinery to enhance targeting specificity and reduce resistance development.
"This milestone builds upon the highly encouraging data from our CARB-X funded Phase 1a trial in healthy volunteers, where SNIPR001 demonstrated promising safety and target engagement," said Dr. Christian Grøndahl, Co-founder and CEO of SNIPR Biome.
The precision approach offers potential advantages over broad-spectrum antibiotics by selectively eliminating pathogenic E. coli while preserving beneficial gut microbiota, addressing a critical gap in current treatment options.
Addressing Drug-Resistant Infections in Vulnerable Populations
The therapy targets a significant clinical challenge in hematological cancer care. Escherichia coli causes 25-30% of bacteremia cases in neutropenic hematological cancer patients, with up to 65% of bloodstream isolates showing fluoroquinolone resistance. Current prophylactic treatments with broad-spectrum antibiotics contribute to further resistance development and disrupt beneficial gut microbiota.
"Despite the significant advances in hematologic cancer therapy over the past decade, infectious complications, and antimicrobial resistance continue to pose significant threats to patients and clinical outcomes," the company noted. Currently, there are no approved therapies for the prevention of bloodstream infections in hematological cancer patients.
Phase 1b Trial Design and Objectives
The Phase 1b trial (NCT06938867) is a randomized, double-blind, placebo-controlled study being conducted at eight centers in the United States. The trial will investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of orally administered SNIPR001 in 24 patients with hematological cancer who are undergoing HSCT and are colonized with fluoroquinolone-resistant E. coli.
The study builds upon encouraging Phase 1a safety data in healthy volunteers, where SNIPR001 demonstrated promising safety profiles and successful target engagement. The trial is co-funded by CARB-X, a global non-profit partnership dedicated to supporting early-stage antibacterial research and development to address the rising threat of drug-resistant bacteria.
Industry Recognition and Future Implications
Dr. Erin Duffy, Chief of Research & Development at CARB-X, emphasized the significance of this clinical advancement: "SNIPR001 represents a scientifically innovative strategy that could contribute to addressing an urgent clinical challenge in preventing drug-resistant infections in vulnerable cancer patients."
The Phase 1/2 trial marks a significant advancement in the clinical development of engineered phage therapies for combating antimicrobial resistance in high-risk patient populations. SNIPR Biome was the first company to orally dose humans with a CRISPR therapeutic and the first to receive US and European patents for using CRISPR to target microbiomes.
The company's technology platform is being utilized in collaborations with CARB-X, Gates Foundation, IPATH, SPRIN-D, and MD Anderson Cancer Center, highlighting the broad potential applications of this precision microbial gene therapy approach.
