Escherichia Coli (E. Coli.) bacteria under microscope
Escherichia Coli (E. Coli.) bacteria under microscope. [Source: cgtoolbox/Getty Images]

CRISPR- and microbiome-focused biotech company SNIPR BIOME announced earlier this week its first drug candidate, SNIPR001, which seeks to prevent blood stream infections by E. coli in patients with hematologic cancer has been granted a Fast Track Designation by the United State Food and Drug Administration (FDA). The designation comes two weeks after the FDA accepted the company’s Investigational New Drug Application.

A fast track designation is granted by the FDA “to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need,” according to the agency’s website. To date, there is no approved medication that seeks to prevent E. coli infections in the bloodstream that could compromise the treatment of patients with hematologic cancers.

The FDA’s fast track designation highlights that SNIPR001 could “be a game-changer for hematological cancer patients at increased risk of life-threatening bloodstream infections caused by E. coli,” said Dr. Christian Grøndahl, co-founder and CEO of Copenhagen-based SNIPR BIOME in a press release. “E. coli was recently highlighted as one of the leading pathogens associated with anti-microbial resistance (AMR) and death in a systematic review published by the scientific journal The Lancet, so there is an urgent need for new medicines targeting E. coli.”

SNIPR BIOME is developing it drug candidate in collaboration with the non-profit CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator). The intent is to selective target E. coli bacteria in the gut as a means of preventing the translocation of the bacteria into the bloodstream, while leaving the commensal bacteria in the gut unaffected. CARB-X recently provided a grant of $10.2 million to the biotech company to develop SNIPR001 for a CRISPR-based treatment of hematological cancer patients at risk of neutropenic fever and life-threatening infections.

SNIPR has developed a novel use of CRISPR-Cas technology that it says can selectively target and eradicate bacteria. It accomplishes this by using the bacteria’s adaptive CRISPR-based immune system, in a programmable fashion, to very selectively kill target bacteria based on specific DNA sequence signatures in the bacterial genome. The company also develops proprietary technologies for in situ production of therapeutics in the human microbiome. To date, the company has been awarded 20 patents in the U.S. for its proprietary technologies for drug development and production.

It currently has research collaborations with MD Anderson Cancer Center and Novo Nordisk applying it technology to diverse medical needs.

With MD Anderson, the company and the cancer center are investigating the use of CRISPR-based microbiome therapeutics as a means to reduce immune-related adverse events (irAE) in patients being treated with combined immune checkpoint inhibitors. According to the announcement of the research partnership, “MD Anderson and SNIPR BIOME will collaborate to validate proprietary microbiome profiles and to develop CRISPR-armed therapeutic entities to modulate the gut microbiota with the goal of reducing toxicity while preserving response to treatment with immune checkpoint inhibitors for cancer.”

With Novo Nordisk, the company sealed a research agreement in June last year on an undisclosed target to evaluate SNIPR BIOME’s proprietary technology for in situ production of therapeutics in the human microbiome. As Grøndahl noted at the time: “Delivering genes to the microbiome to enable in situ production of proteins and peptides has almost unlimited potential. Engineered proteins and peptides can be enzymes that target unwanted gut metabolites, anti-cytokines to dampen autoimmune inflammation in e.g. IBD, immune-oncology antibodies, or signaling molecules/hormones. The potential scope for our technology is extensive.”

With the groundwork it has laid and the new Fast Track Designation, SNIPR BIOME anticipates it will open its first clinical trial of SNIP001 before the end of the first half of the year.

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