Morrisville, NC – November 10, 2020 – Locus Biosciences, a clinical-stage biopharmaceutical company, announced today that it has signed a contract with the global non-profit, Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) to fund up to $12.5 million of a $14.8 million program for development of LBP-KP01, a CRISPR Cas3-enhanced bacteriophage (crPhage™) product targeting the bacterial pathogen Klebsiella pneumoniae (K. pneumoniae).
The initial target indication will be recurrent urinary tract infections (rUTIs), similar to Locus’ crPhage product targeting the common bacterial pathogen Escherichia coli (E. coli) that has been funded by BARDA. Locus also intends to develop the product for infections of other body sites, such as lung infections (pneumonia), intra-abdominal infections (IAIs), and bacteremia.
The proposed K. pneumoniae product will be part of an arsenal of products, including the existing crPhage cocktail targeting E. coli and products targeting two undisclosed pathogens that Locus is developing in collaboration with Johnson & Johnson, designed to address serious infections irrespective of underlying drug-resistance within the species. Together, the E. coli and K. pneumoniae cocktails have the potential to treat more than 90% of UTIs.
The CARB-X contract will provide to Locus $2.05 million initially and up to $10.56 million over three years to fund preclinical development of LBP-KP01 and Phase 1 clinical trials.
“We are very excited to partner with CARB-X to advance LBP-KP01 into clinical trials,” said Paul Garofolo, CEO of Locus Biosciences. “This funding is another important validation of Locus’ rapid development of innovative CRISPR-Cas3 enhanced bacteriophage products, enabling Locus to advance a robust pipeline that includes products targeting four of the most common bacterial pathogens as well as products targeting microbiome-related disorders such as inflammatory bowel disease, pharmaceutical response to immune-oncology therapies, infections associated with immune checkpoint inhibitors and, colorectal cancer.”
LBP-KP01 is a bacteriophage cocktail that has been engineered with a CRIPSR-Cas3 construct targeting the K. pneumoniae 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-KP01 significantly more effective at killing K. pneumoniae cells than corresponding natural bacteriophages. The mechanism also makes LBP-KP01 effective in killing K. pneumoniae strains regardless of whether they are resistant to antibiotics.
The increasing use of antibiotics to treat secondary infections during a pandemic, such as those caused by H1N1 influenza or SARS-CoV-2, is leading to more antibiotic-resistant infections. There is a large unmet need for new precision antibacterial therapies that selectively kill targeted bacteria while leaving good bacteria in the body unharmed.
“Locus’ approach combines the bacteria-hunting activity of bacteriophages with the DNA targeting activity of CRISPR-Cas3 to treat recurring UTI infections caused by K. pneumoniae,” said Erin Duffy, R&D Chief of CARB-X. “This approach has the potential to kill with laser-sharp precision the bacteria causing an infection without causing damage to other cells. If successful, this could transform the treatment of these serious life-threatening infections and save lives.”
Worldwide, an estimated 150 million people are affected by UTIs each year. Up to 40% of UTI patients experience a recurrence within months of the first episode from difficult-to-treat strains that are resistant to commonly used antibiotics. Both the U.S. Centers for Disease Control and Prevention (CDC) and World Health Organization (WHO) have identified antibiotic-resistant K. pneumoniae 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 its genetic material 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 CRISP-enhanced precision antibacterial products (crPhageTM) to address critical unmet medical needs in bacterial infections and microbiome indications in oncology, immunology and neuroscience therapeutics 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/
CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) is a global non-profit partnership dedicated to supporting early development antibacterial R&D to address the rising threat of drug-resistant bacteria. CARB-X is led by Boston University and funding is provided by the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the US Department of Health and Human Services; the Wellcome Trust, a global charity based in the UK working to improve health globally; Germany’s Federal Ministry of Education and Research (BMBF); the UK Department of Health and Social Care’s Global Antimicrobial Resistance Innovation Fund (GAMRIF); the Bill & Melinda Gates Foundation, and with in-kind support from National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH) within the US Department of Health and Human Services. CARB-X is investing up to US$480 million from 2016-2022 to support innovative antibiotics and other therapeutics, vaccines, and rapid diagnostics. CARB-X focuses exclusively on high priority drug-resistant bacteria, especially Gram-negatives. CARB-X is headquartered at Boston University School of Law. https://carb-x.org/. Follow us on Twitter @CARB_X