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Trial Begins Testing Crispr Gut Microbiome Therapy

E. coli

Escherichia coli, or E. coli, bacteria (National Institute of Allergy and Infectious Diseases)

20 Apr. 2022. A clinical trial is underway assessing a genetically edited oral drug designed to remove E. coli bacteria in the gut, a danger for patients with blood-related cancers. The study is testing an experimental drug code-named Snipr001, developed by Snipr Biome ApS in Copenhagen, Denmark, sponsor of the trial.

Snipr Biome creates therapies that work in the gut microbiome, naturally occurring intestinal microbe communities, with the gene editing technology Crispr, short for clustered regularly interspaced short palindromic repeats. Crispr is a genome-editing process based on bacterial defense mechanisms that use RNA to identify and monitor precise locations in DNA. The company says its technology can deliver edited DNA to kill harmful bacteria in the gut, prevent bacterial infections, or as a type of gene therapy, by adding sequences that code for therapeutic peptides or proteins.

With its Crispr-based technology, Snipr Biome says it delivers therapies, either with bacteriophages, a type of virus that infects bacteria, or bacterial conjugation, where one organism transfers material to another through direct contact. The company says its therapies are administered as oral drugs, injections, or applied through the skin.

Avoiding other beneficial gut microbes

Snipr001 is designed as a treatment for E. coli bacteria in the blood stream of patients with hematological or blood-related cancers that also affect bone marrow and lymph nodes. Patients with blood-related cancers, particularly those receiving chemotherapy, run a higher risk of blood stream infections from E. coli, with broad-spectrum antibiotics normally the only treatment. Snipr001, says Snipr Biome, attacks E. coli bacteria with characteristic genetic sequences in the gut before they reach the blood stream, while avoiding harm to other beneficial gut microbes.

In May 2021, Snipr Biome received $3.9 million from Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator, or CARB-X, an international consortium funding R&D on new treatments addressing drug-resistant bacteria in cancer patients. The company is also eligible for another $6.3 million in future developmental milestone payments from CARB-X. In Sept. 2021, Science & Enterprise reported on Snipr Biome’s collaboration with M.D. Anderson Cancer Center in Houston to develop gene-edited therapies that work in the gut to reduce adverse effects from cancer immunotherapies.

The early-stage clinical trial is enrolling 36 healthy adults at a site in Cincinnati, Ohio to test the safety and tolerability of Snipr001. Participants are randomly assigned to receive Snipr001 or a placebo twice a day, in one of three dosage levels, for seven days. The study team is looking primarily for adverse effects among participants in the 35 days after taking Snipr001. The team is also testing blood, urine, and stool samples for signs of Snipr001 in that 35 day period, as well as tracking participants for another five months for signs of adverse effects.

Christian Grøndahl, Snipr Biome’s co-founder and CEO says in a company statement that the clinical trial “is only the beginning, and we truly believe that Snipr001 could have the potential to help hematological cancer patients at increased risk of life-threatening blood stream infections caused by multi-drug resistant E. coli.” Milan Zdravkovic, the company’s chief medical officer adds, “We are in parallel pursuing our pipeline of Crispr medicines of exciting targets within oncology, immunology and cardio-metabolism, and have an ambition of selecting the next molecule from our pipeline to move into [investigational new drug] enabling studies also by the end of this year.”

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