FDA Grants Fast Track Designation to SNIPR001 for Preventing Blood Infections in Hematologic Malignancies

SNIPR001, an agent developed to target E. coli in patients with hematologic cancer who are at risk for neutropenia, was granted fast track designation by the FDA, according to a press release from developer SNIPR BIOME ApS.¹

Prior to the designation, which will aid in the development and will expedite the review process for SNIPR001, the FDA recently accepted the investigational new drug application, which led to a first in-human clinical trial.

“At SNIPR BIOME, we are extremely proud to have been granted Fast Track designation by the FDA. It underlines SNIPR001's potential to be a game-changer for [patients with] hematological cancer [who are] at [an] increased risk of life-threatening bloodstream infections caused by E. coli,” Christian Grøndahl, eMBA, PhD, MD, co-founder and chief executive officer, said 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.”

SNIPR001 was designed to target E. coli bacteria in the gut and thus prevent it from entering the bloodstream in addition to sparring commensal bacteria within the microbiome. SNIPR Biome’s precision medicine CRISPR/Cas technology is being used to better prevent and treat E. coli infections within this population.

The new drug application, which was accepted on January 11, 2022, will allow SNIPR BIOME to launch the clinical trial in the first half of 2022.² The study will aim to assess the safety profile of SNIPR001 in a healthy population, and will examine the agent’s impact on colonization of E. coli in the gut. The study’s population includes those who have been diagnosed with hematologic malignancies and are at increased risk of blood infections to their disease, treatment with chemotherapy, and bacterial translocation from the gut.

Currently, no prophylactic therapies have been approved by the FDA for this purpose, although SNIPR001 could be the first of several potential therapeutic options.

“Based on our pre-clinical data with SNIPR001, we believe that our technology holds a huge potential in designing tomorrow's CRISPR-based medicines against life-threatening infections and to modulate microbiome-associated diseases. With the rise in anti-microbial resistance, there is an urgent need for novel drug candidates to treat infectious bacteria, such as E. coli, and we are grateful for the collaboration with the non-profit organization, CARB-X on SNIPR001,” Milan Zdravkovic, MD, PhD, chief medical officer, and head of R&D at SNIPR BIOME, concluded.

References

1. SNIPR BIOME announces U.S Food and Drug Administration grants fast track designation for SNIPR001 for prevention of bloodstream infections in hematologic cancer patients. News release. SNIPR Biome ApS. January 25, 2022. Accessed January 25, 2022. https://bit.ly/3tZbx8l
2. SNIPR BIOME announces FDA clearance of investigational new drug (IND) application for SNIPR001, a novel CRISPR therapy targeting life-threatening E. coli infections. News release. SNIPR Biome ApS. January 11, 2022. Accessed January 25, 2022. https://prn.to/3G4v9KC