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All • Cefepime-Taniborbactam • Ceftibuten/VNRX-7145

ECCMID 2021

July 9 - 12, 2021

Abstract 02128 – Cefepime-taniborbactam (formerly cefepime/VNRX-5133) demonstrates potent activity vs. Enterobacterales with blaOXA-48

Abstract 02144 – Examining the antimicrobial activity of cefepime-taniborbactam (formerly cefepime/VNRX-5133) against Burkholderia species isolated from cystic fibrosis patients in the United States

Abstract 02564 – Antimicrobial Activity of Cefepime in Combination with Taniborbactam (formerly VNRX-5133) Against a European 2018-2020 Surveillance Collection of Pseudomonas aeruginosa

Abstract 02581 – Antimicrobial Activity of Cefepime in Combination with Taniborbactam (formerly VNRX-5133) Against Clinical Isolates of Enterobacterales from Europe Collected from 2018-2020 Surveillance

Abstract 03198 – Evaluation of the in vitro activity of cefepime-taniborbactam against carbapenemase-producing Enterobacterales recovered in Spain

Abstract 03200 – Exploring the in vitro activity of cefepime/taniborbactam combination against metallo beta-lactamase producing Klebsiella pneumoniae and Pseudomonas aeruginosa isolates

Abstract 03285 – Assessment of activity of a novel orally bioavailable β-lactam/β-lactamase inhibitor combination, ceftibuten/VNRX-7145 (VNRX-5236 etzadroxil) against Enterobacterales carrying blaOXA-48

Abstract 03578 – Activity of cefepime-taniborbactam (formerly cefepime/VNRX-5133) and comparators against NDM-producing Enterobacterales from a regional outbreak

International Liver Congress 2021

June 23 - 26, 2021

Discovery and preclinical profile of VNRX-9945, a potent, broadly active core protein inhibitor for the treatment of chronic hepatitis B virus (HBV) infection

World Microbe Forum 2021

June 20 - 24, 2021

Association of Cefepime-Taniborbactam MICs and β-lactam Resistance Mechanisms Identified Using Whole Genome Sequencing of Ertapenem-nonsusceptible Enterobacterales Clinical Isolates: CANWARD 2007-2018

In Vitro Activity of Cefepime-Taniborbactam against Ertapenem-nonsusceptible Enterobacterales Obtained Across Canada: CANWARD 2007-2019

In Vivo Efficacy of Cefepime-Taniborbactam Against Beta-Lactamase-Producing Enterobacterales and Pseudomonas Aeruginosa in a Neutropenic Murine Complicated Urinary Tract Infection Model

IDWeek 2020

October 21 - 25, 2020

Poster 1263 - Assessment of Cefepime (FEP)-Taniborbactam (TAN) Human Exposures to Suppress the Emergence of Resistance among Serine (SBL)- and Metallo-Beta-Lactamase (MBL)-Producing Gram-Negative Bacteria (GNB) in a Hollow Fiber Infection Model (HFIM)

Poster 1318 - Pharmacokinetics and Safety of Cefepime-Taniborbactam (formerly Cefepime/VNRX-5133) in Subjects with Renal Impairment

ECCMID 2020

April 18 - 21, 2020

P0284 – A multi-site study comparing a commercially-prepared dried MIC susceptibility system to the CLSI/ISO broth microdilution method for cefepime-taniborbactam (formerly cefepime/VNRX-5133) using Gram-negative non-fastidious organisms

P2119 – Impact of porin deletions on the in vitro antimicrobial activity of cefepime-taniborbactam (formerly cefepime/VNRX-5133) in Klebsiella pneumoniae

P2737 - Antimicrobial Activity of Cefepime in Combination with Taniborbactam(formerly VNRX-5133) against a European 2018-2019 Surveillance Collection of Pseudomonas aeruginosa

P2738 – Antimicrobial Activity of Cefepime in Combination with Taniborbactam (formerly VNRX-5133) Against Clinical Isolates of Enterobacterales from Europe Collected from 2018-2019 Surveillance

ASM Microbe 2019

June 23, 2019

SUNDAY - AAR-719 - Rescue of Ceftibuten Activity by the Oral Beta-Lactamase Inhibitor VNRX-7145 against Enterobacteriaceae Expressing Class A, C and/or D Beta-Lactamases

SUNDAY - AAR-720 - The Orally Bioavailable Beta-Lactamase Inhibitor VNRX-7145 Restores Bactericidal Activity of Ceftibuten against Enterobacteriaceae Expressing Ambler Class A, C, and/or D Enzymes.

SUNDAY - AAR-721 - In Vitro Activity of Ceftibuten in Combination with VNRX-7145 and Comparators against 1,066 UTI Isolates Non-Susceptible to Amoxicillin-Clavulanate and Levofloxacin.

SUNDAY - AAR-722 - Antimicrobial Activity of Cefepime in Combination with VNRX-5133 against a Global 2018 Surveillance Collection of Pseudomonas aeruginosa.

SUNDAY - AAR-723 - Synergy/Antagonism of Ceftibuten/VNRX-7145 in Combination with Other Commonly Used Antimicrobial Agents in Gram-Negative Aerobic Bacteria, Anaerobic Bacteria, and Yeast.

SUNDAY - AAR-724 - In Vitro Permeability and Metabolic Biotransformation of Oral Beta-Lactamase Inhibitor VNRX-7145 across Species.

SUNDAY - AAR-726 - Efficacy of Ceftibuten + VNRX-7145, a Novel Beta-Lactamase Inhibitor against ESBL E. coli Strains in a Murine UTI Model

SUNDAY - AAR-727 - Assessment of the In Vivo Pharmacodynamic Profile of Ceftibuten (CTB)/VNRX-7145 Combination against Serine β-Lactamase-Producing Enterobacteriaceae (SBL-EB) in the Neutropenic Murine Thigh Infection Model

SUNDAY - AAR-728 - Oral Bioavailability of Novel Beta-Lactamase Inhibitor VNRX-7145 in Rats, Dogs and Non-Human Primates

SUNDAY - CPHM-860 - Impact of Variations in Susceptibility Testing Parameters on the In Vitro Activity of Ceftibuten in Combination with VNRX-7145 ECCMID 2019

ECCMID 2019

April 13 - 16, 2019

#O1061— Pharmacodynamics of VNRX-5133 in combination with cefepime studied in an in vitro model of infection.

#O1064 — In vivo pharmacodynamic profile of cefepime in combination with VNRX-5133 against serine beta-lactamase-producing Gram-negative bacteria in the neutropenic murine thigh infection model.

#P1175 — Antimicrobial activity of cefepime in combination with VNRX-5133 against a global 2018 surveillance collection of clinical isolates.

#P1176 — Antimicrobial activity of cefepime in combination with VNRX-5133 against a collection of beta-lactamase-producing Enterobacteriaceae.

#P1177 — Activity of cefepime/VNRX-5133 and comparators against an Italian nationwide collection of Pseudomonas aeruginosa from respiratory and bloodstream infections.

#P1178 — VNRX-5133 maintains potent inhibitory activity in engineered NDM-1 variants with increased cefepime hydrolytic efficiency.

#P1179 — Evaluation of the in vitro activity of cefepime plus VNRX-5133 and comparative agents against carbapenem-resistant Enterobacteriaceae.

#P1180 — In vitro activity of the orally available ceftibuten/VNRX-7145 combination against a challenge set of Enterobacteriaceae pathogens carrying molecularly characterised beta-lactamase genes.

#P1181 — Selection of ceftibuten as the partner antibiotic for the oral beta-lactamase inhibitor VNRX-7145.

#P1182 — Ceftibuten/VNRX-7145, an orally bioavailable beta-lactam/beta-lactamase inhibitor combination active against serine-beta-lactamase producing Enterobacteriaceae.

#P1183 — Oral ceftibuten/VNRX-7145 shows equivalent activity in vitro to IV therapeutics against MDR Enterobacteriaceae.

#P1951 — Pharmacokinetics of VNRX-5133 in Combination with Cefepime and Metronidazole.

IDWeek 2018

October 3 - 7, 2018

Poster 1360 – Antimicrobial Activity of Cefepime in Combination with VNRX-5133 Against a Global Collection of Enterobacteriaceae Including Resistant Phenotypes.

Poster 1370 – Cefepime/VNRX-5133 Broad-Spectrum Activity is Maintained against Emerging KPC- and PDC-Variants in Multidrug Resistant K. pneumoniae and P. aeruginosa.

Poster 1395 – Defining the Magnitude of AUC:MIC Driver for Efficacy of the beta-lactamase Inhibitor VNRX-5133 when combined with Cefepime against KPC- and VIM/NDM-producing Enterobacteriaceae and P. aeruginosa.

Poster 1401 – A Randomized, Double-blind, Placebo-controlled Study of the Safety and Pharmacokinetics of Single and Repeat Doses of VNRX-5133 in Healthy Subjects.

Poster 1405 – Efficacy of the Human-Simulated Regimen (HSR) of Cefepime (FEP)/VNRX-5133 Combination against Serine beta-lactamase-Producing Gram-negative Bacteria in the Neutropenic Murine Thigh Infection Model.

ASM Microbe 2018

June 7 - 11, 2018

FRIDAY 226 — Development of CLSI MIC and disk diffusion quality control ranges for Cefepime/VNRX-5133.

FRIDAY 609 — In vitro activity of cefepime in combination with VNRX-5133 against gram-negative UTI isolates.

FRIDAY 610 — Cefepime/VNRX-5133 retains potent activity against KPC variants responsible for recent clinical treatment failures of Ceftazidime/Avibactam in Klebsiella Pneumoniae.

FRIDAY 611 — Evaluation of the Impact of Variation in Standard Testing Parameters on the Activity of Cefepime in Combination with VNRX-5133.

FRIDAY 612 — Efficacy of cefepime combined with VNRX-5133, a novel broad-spectrum beta-lactamase inhibitor, against a cephalosporin-resistant ESBL E. coli in a murine UTI model

ECCMID 2018

April 21 - 24, 2018

#O0575 — Pharmacodynamics of the novel broad-spectrum beta-lactamase inhibitor VNRX-5133 in combination with cefepime in neutropenic female CD-1 mice with experimental pneumonia.

#O0600 — Efficacy of cefepime / VNRX-5133, a novel beta-lactamase inhibitor combination, against cephalosporin-resistant, ESBL-producing K. pneumoniae in a murine lung-infection model.

#O0603 — Structural basis for serine- and metallo-beta-lactamase inhibition by VNRX-5133, a new beta-lactamase inhibitor (BLI) in clinical development.

#O0606 — Kinetic mechanism and parameters of inhibition of serine KPC-2, CTX-M15, p99 AmpC and metallo VIM-2 by the broad-spectrum beta-lactamase inhibitor VNRX-5133.

#P1536 — Potentiation of cefepime by the boronate VNRX-5133 versus gram-negative bacteria with known beta-lactamases.

#P1537 — Pharmacokinetics-pharmacodynamics (PK-PD) of VNRX-5133, a broad-spectrum novel beta-lactamase inhibitor (BS-BLI), in combination with cefepime in a one-compartment in vitro infection model.

#P1538 — Efficacy of cefepime / VNRX-5133, a novel broad-spectrum beta-lactamase inhibitor, in a murine bacteremia infection model with carbapenem-resistant Enterobacteriaceae (CREs).

#P1539 — In vitro activity of cefepime alone and in combination with the broad-spectrum beta-lactamase inhibitor VNRX-5133 against ESBL and carbapenamases harbouring Enterobacteriaceae and Pseudomonas spp.

#P1540 | VNRX-5133, a novel broad-spectrum beta-lactamase inhibitor, enhances the activity of cefepime against Enterobacteriaceae and P. aeruginosa isolates in a neutropenic mousethigh infection model.

#P1541 | Susceptibility to cefepime / VNRX-5133 in 298 carbapenem-resistant Enterobacteriaceae producing serine- and metallo-beta-lactamases.

#P1542 | In vitro activity of cefepime in combination with VNRX-5133 against meropenem and/or cefepime resistant clinical isolates of Pseudomonas aeruginosa.

#P1543 | Antimicrobial activity of cefepime in combination with VNRX-5133 against a global collection of clinical isolates.

#P1544 | In vitro activity of cefepime in combination with VNRX-5133 when tested against cephalosporin and carbapenem resistant beta-lactamase producing gram-negative isolates.

#P1545 | The ability of broad-spectrum beta-lactamase inhibitor VNRX-5133 to restore bactericidal activity of cefepime in Enterobacteriaceae- and P. aeruginosa-expressing Ambler class A, B, C and D enzymes is demonstrated using time-kill kinetics.