Cefepime-Taniborbactam

Venatorx Pharmaceuticals’ most advanced development-stage product is taniborbactam (formerly VNRX-5133), an injectable beta-lactamase inhibitor (BLI) that features selective and potent in vitro activity against both serine- and metallo-beta-lactamases (MBLs), including the following enzymes:

  • extended spectrum beta-lactamase (ESBL);
  • Oxacillinase (OXA);
  • Klebsiella pneumoniae carbapenemase (KPC);
  • New Delhi metallo-beta-lactamase (NDM); and
  • Verona integron-encoded metallo-beta-lactamase (VIM).

Venatorx believes that taniborbactam, in a fixed combination with the fourth generation cephalosporin, cefepime, has the potential to provide a valuable broad-spectrum treatment option to meet unmet medical needs in patients with infections due to carbapenem-resistant pathogens including carbapenem-resistant Enterobacterales (CRE) and carbapenem-resistant Pseudomonas aeruginosa (CRPA), suspected polymicrobial infections caused by both gram-negative and gram-positive susceptible pathogens, and engineerable bioterror pathogens such as Burkholderia spp.

Venatorx is currently enrolling a Phase 3 clinical trial of cefepime-taniborbactam in patients with complicated urinary tract infections (cUTIs).

This Phase 3 clinical trial (ClinicalTrials.gov – NCT03840148) is a global randomized, double-blind, active controlled, non-inferiority study evaluating the efficacy, safety, and tolerability of cefepime-taniborbactam in adults with cUTI, including acute pyelonephritis. The trial will assess the safety and efficacy of cefepime-taniborbactam as compared with that of meropenem using clinical cure and microbiological eradication as the primary composite efficacy endpoint.

This project has been funded in whole or in part with federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272201300019C, The Wellcome Trust under Award No. 360G-Wellcome-101999/Z/13/Z, and the Biomedical Advanced Research and Development Authority, Office of the Assistant Secretary for Preparedness and Response, Department of Health and Human Services under Contract No. HHSO100201900007C.

Exclusive License Agreement with Everest Medicines II Limited

In September 2018, Venatorx entered into an exclusive license agreement  (“License Agreement”) with Everest Medicines II Limited (“Everest”), a C-Bridge Capital-backed biopharmaceutical company with operations based in China, to support the development, registration and commercialization of cefepime-taniborbactam in Greater China, South Korea and Southeast Asia  (“the Territory”) for cUTI, infections due to carbapenem resistant pathogens, and hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP). Under the terms of the License Agreement, Venatorx and Everest will collaborate on the global Phase 3 clinical development trials of cefepime-taniborbactam, Everest will be solely responsible for the commercialization of cefepime-taniborbactam in the Territory, and Venatorx will be eligible to receive royalties on net sales of cefepime-taniborbactam in the Territory.

 

Collaboration  with the Global Antibiotic Research and Development Partnership (GARDP)

In April 2020, Venatorx and GARDP announced a collaboration to accelerate the development of, and access to, cefepime-taniborbactam. GARDP is collaborating with Venatorx to complete the development of cefepime-taniborbactam, including the Phase 3 cUTI trial; additional clinical trials in adults with multidrug-resistant infections; and clinical development activities and trials to enable cefepime-taniborbactam to be used for children, including newborns with serious bacterial infections. Venatorx is committed to working with GARDP to distribute cefepime-taniborbactam on an affordable basis worldwide. Venatorx has granted GARDP exclusive rights to distribute and sub-distribute cefepime-taniborbactam, once it is approved for clinical use, in most low- and lower middle-income countries.