Morrisville, NC – September 30, 2020 – Locus Biosciences announced today that it has signed a contract with the Biomedical Advanced Research and Development Authority (BARDA) to co-fund development of LBP-EC01, a CRISPR Cas3-enhanced bacteriophage (crPhage™) product that will target Escherichia coli (E. coli) bacteria causing recurrent urinary tract infections (UTIs).
Under the partnership agreement announced today, BARDA, part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS), will provide up to $77 million in funding to Locus as part of a $144 million program to support Phase 2 and Phase 3 clinical trials and other activities required to seek marketing approval from the U.S. Food and Drug Administration (FDA) for LBP-EC01.
LBP-EC01 is a bacteriophage cocktail that has been engineered with a CRISPR-Cas3 construct targeting the E. coli genome. The product works through a unique dual mechanism of action utilizing the natural lytic activity of the bacteriophage along with the DNA-targeting activity of CRISPR-Cas3. This dual mechanism makes LBP-EC01 significantly more effective at killing E. coli cells than corresponding natural bacteriophages, as shown both in laboratory tests and in small animal models of urinary tract infection. The mechanism also makes LBP-EC01 effective in killing E. coli strains regardless of whether they are resistant to antibiotics.
Antibiotic-resistant infections are a particular concern with large-scale use of antibiotics to treat secondary infections during a pandemic, such as those caused by H1N1 influenza or SARS-CoV-2. The need for new precision antibacterial therapies that selectively kill target bacteria while leaving good bacteria in the body unharmed is widely recognized.
“The development of non-traditional therapies that possess alternative properties to conventional small-molecule antibiotics represents a unique opportunity to advance the field of medicine and provide new treatment options to patients with antimicrobial-resistant infections which are a growing concern for our nation’s health security,” said BARDA Acting Director Gary Disbrow, Ph.D.
“We are incredibly pleased to partner with BARDA to advance our lead asset into advanced clinical trials,” said Paul Garofolo, CEO of Locus. “Not only will BARDA provide critical expertise to support the program through the later stages of clinical development, but its support dramatically increases the profile of precision medicines to address the emerging worldwide public health crisis around antibiotic resistant infections.”
Worldwide, an estimated 150 million people are affected by UTIs each year. Approximately 80% of these are caused by E. coli, often including difficult-to-treat strains that are resistant to commonly used antibiotics. Up to 40% of UTI patients experience a recurrence within months of the first episode. Both the U.S. Centers for Disease Control and Prevention (CDC) and World Health Organization (WHO) have identified antibiotic-resistant E. coli as an urgent and serious public health threat requiring development of new treatments.
About Bacteriophage Therapy
Bacteriophage are viruses that specifically attack bacterial cells. They are ubiquitous in the environment and are the most common organisms on the planet, outnumbering bacteria by an estimated 10 to 1. When a phage targets a bacterial cell, it injects DNA into the cell that hijacks the cell’s machinery and uses it to create new copies of itself. The infected bacterium is killed in the process of releasing tens or hundreds of new phages, which go on to infect additional bacteria. Bacteriophage have been used as antibacterial therapy since shortly after they were discovered in the early 20th century. Bacteriophage therapy has enjoyed renewed interest from the medical community in recent years as antibiotic resistance has emerged as a serious global public health threat.
About Locus Biosciences
Locus Biosciences is a clinical-stage biotechnology company developing CRISPR-enhanced precision antibacterial products (crPhage™) to address critical unmet medical needs in bacterial infections and microbiome indications in oncology, immunology and neuroscience therapeutic areas. The Locus platform combines CRISPR-Cas3, which permanently degrades target DNA within a bacterial cell, with bacterial viruses called bacteriophage to specifically kill target pathogens while leaving non-target bacteria (i.e., the rest of the patient’s microbiome) unharmed. For more information about Locus visit https://locus-bio.com/.
HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of ASPR is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA invests in innovation, advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products needed to combat health security threats. To date, BARDA-supported products have achieved 55 U.S. Food and Drug Administration approvals. To learn more about partnering with BARDA, visit medicalcountermeasures.gov and to find more about preparing for and responding to public health emergencies, from new infectious diseases to natural disasters and bioterrorism, visit the HHS public health emergency website, phe.gov. To learn more about federal support for the nationwide COVID-19 response, visit coronavirus.gov.