SNIPR BIOME Begins Phase 1b Trial of SNIPR001 for Hematological Cancer

COPENHAGEN, Denmark I June 12, 2025 I SNIPR Biome ApS, a leader in the development of precision medicines utilizing CRISPR technology for microbial gene therapy, has announced the commencement of dosing in its Phase 1b clinical trial involving SNIPR001. This study focuses on patients with hematological cancer who are undergoing hematopoietic stem-cell transplantation (HSCT).

The Phase 1b trial, identified as NCT06938867, is taking place across eight different centers within the United States. It is financially supported by CARB-X, a global non-profit collaboration committed to advancing early-stage antibacterial research to tackle the growing threat posed by drug-resistant bacteria. The trial is designed as a randomized, double-blind, placebo-controlled study aimed at evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of SNIPR001 when orally administered to 24 participants with hematological cancer.

SNIPR001 represents a pioneering approach as the first-ever CRISPR-enhanced phage therapeutic explicitly targeting E. coli in the intestinal tract. Its goal is to prevent bloodstream infections caused by E. coli in hematological cancer patients undergoing HSCT who are colonized with Fluoroquinolone Resistant E. coli. Despite advances in treating hematologic cancers over the past decade, infectious complications and antimicrobial resistance remain significant challenges for patients and their treatment outcomes. Currently, there are no approved treatments available for the prevention of bloodstream infections in these patients. SNIPR Biome aims to address this critical gap with SNIPR001, offering a potential solution to combat these infections.

Dr. Christian Grøndahl, Co-founder and CEO of SNIPR Biome, expressed his satisfaction with the progress of their clinical program, stating that the dosing of the first patient marks a pivotal achievement. Enthusiastically, he highlighted the promising safety and target engagement data from their previous CARB-X funded Phase 1a trial conducted with healthy volunteers.

Erin Duffy, PhD, Chief of Research & Development at CARB-X, emphasized the significance of this clinical milestone, noting it as an important step in investigating a novel method to prevent bloodstream infections caused by drug-resistant E. coli in susceptible cancer patients. She acknowledged the scientific innovation embedded in SNIPR001, recognizing its potential contribution to addressing a pressing clinical challenge.

SNIPR Biome is a Danish biotechnology company at the forefront of developing precision medicines using CRISPR technology for microbial gene therapy. By employing a novel application of CRISPR-Cas technology, the company aims to enhance the treatment and prevention of human diseases through targeted bacterial elimination or gene modification. SNIPR Biome is notable for being the first company to administer an oral CRISPR therapeutic to humans and for securing patents in both the US and Europe for utilizing CRISPR in targeting microbiomes. The company collaborates with several organizations, including CARB-X, Gates Foundation, IPATH, SPRIN-D, and MD Anderson Cancer Center, to advance its innovative technology.

By embarking on this Phase 1b trial, SNIPR Biome is taking significant strides in addressing the unmet need for effective infection prevention strategies in hematological cancer patients, potentially transforming the landscape of microbial gene therapy.