SNIPR Biome, a company specialising in the development of precision medicines using CRISPR, has announced that it has received USD $5.48m from Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) to co-fund a Phase 1b/2a clinical trial in haematological cancer patients.
The trial will evaluate SNIPR001, the first CRISPR-armed phage therapeutic that specifically targets E. coli in the gut, to prevent E. coli bloodstream infections in haematological cancer patients who are undergoing haematopoietic stem-cell transplantation (HSCT) and are colonised with Fluoroquinolone Resistant (FQR) E. coli.
Fluoroquinolone is recommended in the US for prophylaxis of bacterial infections and febrile neutropenia in haematological cancer patients at high risk of neutropenia.
Despite the significant advances in haematologic cancer therapy over the past decade, infectious complications and antimicrobial resistance (AMR) continue to pose significant threats to patients and clinical outcomes1.
Currently, there are no approved therapies for the prevention of bloodstream infections (BSIs) in haematological cancer patients. SNIPR Biome is developing SNIPR001 to address this urgent unmet need to combat infections in haematological cancer patients.
Preclinical data published in Nature Biotechnology described SNIPR001’s ability to selectively target and remove antibiotic-resistant E. coli strains in the gut, potentially offering a safe treatment which preserves the rest of the gut microbiome.
This was supported by interim Phase I data published in 2023, which showed that oral dosing of SNIPR001 over seven days across three dosing levels in 24 healthy individuals was well tolerated. Furthermore, SNIPR001 could be recovered in faeces from treated individuals in a dose-dependent manner, and treatment with SNIPR001 numerically lowered gut E. coli levels.
Anticipated to begin later this year, the randomised, double-blinded Phase 1b/2a trial will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of orally administrated SNIPR001 in 24 patients. It will be conducted at up to 10 sites across Europe and the United States.
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, has been a long-term collaborator with SNIPR in this field.
The funding announced today enables SNIPR to move SNIPR001 into Phase 1b/2a clinical trials and will serve as a cornerstone for a further significant fundraise to enable the Company to continue development of its pipeline of CRISPR-based AMR and gut-directed gene therapies.
Dr Christian Grøndahl, Co-founder and CEO of SNIPR Biome, commented: “Antibiotic resistance is one of healthcare’s biggest problems today, affecting treatment efficacy and survival among patients who are often already very sick. We are using our knowledge of gene editing and synthetic biology to create highly specific, ‘designer’ bacteria and phage to disrupt, edit or add genes, and deliver these precision medicines in a carefully targeted way.”
