MORRISVILLE, N.C., Nov. 10, 2020 /PRNewswire/ --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 $10.5 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.

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