Next Gen Diagnostics Announces Agreement to Develop Sequence-Based Susceptibility Determination of Cefiderocol

CAMBRIDGE, Mass., October 7, 2024 (Newswire.com) - Next Gen Diagnostics (NGD), a world leader in the development of validated machine learning models for whole genome sequence-based determination of bacterial susceptibility to antibiotics, announces an agreement with Shionogi & Co., Ltd. (Shionogi) to develop models to predict susceptibility to cefiderocol. Shionogi is a global research-driven pharmaceutical company based in Japan and is the developer of cefiderocol. 

Cefiderocol is an antibiotic that is used to treat infections caused by certain resistant Gram-negative bacteria. Due to cefiderocol’s unique mode of cell entry, a special growth medium is required to assess its activity with certain testing methodologies making it less amenable to conventional, automated phenotypic testing devices. With sequence-based determinations of susceptibility, the need for the special medium would be eliminated, allowing for a differentiated test for cefiderocol susceptibility.

“It is a profound honor to enter into an agreement with Shionogi to develop crucially needed whole genome sequence-based determination of susceptibility for cefiderocol,” noted Dr. Paul A. Rhodes, NGD Founder and CEO. “This goes beyond a commercial opportunity: humanity desperately needs novel antibiotics, and Shionogi has delivered one with a unique mechanism of cell entry. NGD looks forward to partnering with Shionogi to support this important treatment option by providing a reliable and accurate testing method.”

NGD has built methods and infrastructure to develop and validate whole genome sequencing-based machine learning models to determine antibiotic susceptibility in Gram-negative bacteria. NGD has demonstrated these models to be useful tools to show plausible potential resistance pathways, which can help guide healthcare professionals’ approach to antibiotic use.

“This agreement with NGD will advance our efforts to provide different testing options for cefiderocol,” said Boudewijn de Jonge, PhD, Director, Microbiology, Shionogi Inc. “NGD’s methods will help us better understand the complex, though infrequent, cefiderocol resistance mechanisms.” 

In the U.S., cefiderocol is indicated in patients 18 years of age or older for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis caused by the following susceptible Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and Enterobacter cloacae complex. Cefiderocol is also indicated in the U.S. in patients 18 years of age or older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), caused by the following susceptible gram-negative microorganisms: Acinetobacter baumannii complex, Escherichia coli, Enterobacter cloacae complex, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Serratia marcescens.

About Cefiderocol

Cefiderocol for injection is a siderophore cephalosporin antibiotic for the treatment of serious Gram-negative infections manufactured by Shionogi & Co., Ltd. 

It has a novel mechanism for penetrating the outer cell membrane of Gram-negative pathogens by acting as a siderophore. In addition to entering cells by passive diffusion through porin channels, cefiderocol binds to ferric iron and is actively transported into bacterial cells through the outer membrane via the bacterial iron transporters, which function to incorporate this essential nutrient for bacteria. These mechanisms allow cefiderocol to achieve high concentrations in the periplasmic space where it can bind to penicillin-binding proteins and inhibit cell wall synthesis in the bacterial cells.

Cefiderocol received approval from the U.S. Food and Drug Administration (FDA) in 2019, the European Medicines Agency (EMA) in 2020, and the Japanese Ministry of Health, Labor, and Welfare in 2023.

Please click here* for Full U.S. Prescribing Information for cefiderocol.

About Next Gen Diagnostics 

NGD, founded by Dr. Paul A. Rhodes in 2017 along with Sanger Institute group leaders in Cambridge, has built and validated world-leading automation of pathogen bioinformatics, while the unique NGD100 microfluidic sample preparation instrument enables NGD to offer the lowest cost integrated sequencing and bioinformatics services available. NGD combines these capabilities to enable the WGS-based detection of transmission in health care settings, and is working with collaborators in the US, Europe and Israel to be among the first to bring WGS-based determination of antibiotic resistance to patient care.  NGD is based in the US, with subsidiaries in Cambridge, UK and in Israel.

For press inquiries, please contact: [email protected]

Source: Next Gen Diagnostics