Venatorx Pharmaceuticals, based in Malvern, Pennsylvania, today announced that the US Food and Drug Administration (FDA) has accepted for priority review its cefepime-taniborbactam antibiotic combination for treating complicated urinary tract infections (cUTIs).

Cefepime-taniborbactam is an investigational intravenous (IV) beta-lactam/beta-lacatamase inhibitor antibiotic developed for adults with cUTI, including pyelonephritis. The drug has previously received FDA fast-track designation, and the FDA has set a target action date of February 22, 2024.

In a statement, Venatorx said its new drug application is supported by phase 3 study findings that evaluated the efficacy and safety of cefepime-taniborbactam compared to meropenem for treating cUTIs caused by extended-spectrum beta-lactamase (ESBL)-producing Enterobacterales and carbapenem-resistant Enterobacterales. The drug was superior to meropenem for efficacy and was well tolerated, with no new safety issues.

Broad activity against key resistant pathogens

Paul McGovern, MD, the company's senior vice president, said cefepime-taniborbactam has broad-spectrum in vitro activity against established and rapidly increasing carbapenem resistance mechanisms such as serine- and metallo-beta-lactamases. He added that the drug, "if approved, will address a critical unmet need and be a potentially essential treatment option in the continuing fight against antimicrobial resistance in gram-negative bacterial infections."

If approved, [the drug] will address a critical unmet need and be a potentially essential treatment option in the continuing fight against antimicrobial resistance in gram-negative bacterial infections.

More specifically, the drug combo has shown in vitro activity against Centers for Disease Control and Prevention urgent and serious threat pathogens, including carbapenem-resistant Enterobacterales, ESBL-producing Enterobacterales, and multidrug-resistant Pseudomonas aeruginosa.

Venatorx is also evaluating cefepime-taniborbactam as a treatment for hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia.

Sequential vaccines, like those used for COVID-19, may elicit a greater immune response if the recipient has the same arm injected, called ipsilateral vaccination, as opposed to contralateral vaccination, in which the primary vaccination is delivered in one arm and booster dose is delivered to the opposite. The research is published in EBioMedicine.

German scientists tested immune response and ipsilateral versus contralateral vaccination by looking at data from 303 people who received the Pfizer-BioNTech COVID mRNA vaccine. None participants had not contracted COVID-19 prior to vaccination.

Antibody levels were measured 2 weeks after the second dose in 147 participants who received the second dose of COVID-19 vaccine in the same arm as the first, and 156 who got the second shot in the opposite arm. A subgroup of 143 individuals (64 ipsilateral, 79 contralateral) was analyzed for spike-specific CD4 and CD8 T-cells using flow cytometry, the authors said.

Median spike-specific immunoglobulin levels did not differ between the two groups, but neutralizing activity was significantly lower after contralateral vaccination. The number of cytotoxic CD8+ T cells, known as killer T cells, were detected in 67% of same-arm participants, compared to just 43% of the contralaterally vaccinated subjects.

Our study indicates that ipsilateral vaccinations generate a stronger immune response than contralateral vaccinations.

"Our study indicates that ipsilateral vaccinations generate a stronger immune response than contralateral vaccinations," said researcher Laura Ziegler in a Saarland University press release.

More research needs to be done to confirm these findings, the authors said, but they suggest the effect might be due booster vaccination drainage by the same lymph nodes used for priming.

China has reported three plague cases, involving members of the same family from Inner Mongolia autonomous region, Hong Kong's Centre for Health Protection (CHP) said in a statement today.

A woman, from Xilin Gol Meng, was diagnosed as having plague on August 7, and the infections of her husband and daughter were confirmed on August 12.

Plague is caused by the bacterium Yersinia pestis. The disease is transmitted from infected animals, such as rodents, to humans through flea bites. Other transmission modes include breaks in skin that come in contact with body fluids or tissue of infected animals, consuming infected animal tissue, or inhaling respiratory droplets.

The CHP didn't say how the people contracted their infections of what type of plague they had, but a Reuters report that cited a local government statement said the cases are the more common bubonic type.

• Over the past 2 days, virologists in Israel and Denmark have reported what appears to be a second-generation BA.2 lineage Omicron virus that has numerous mutations in the spike protein, while noting that it's too soon to say what impact it will have and exactly what variant it originated from. T. Ryan Gregory, PhD, an evolutionary biologist who specialized in genomic evolution at the University of Guelph in Canada, said on Twitter that it's notable that the virus isn't restricted to one region. Meanwhile, J. Weiland, an infectious disease modeler, said the yet-unnamed new virus' many spike mutations may come with a wider range of outcomes.
• Finland has announced a plan to test all fur farms for avian flu, which would involve inspections at more than 400 facilities, according to Finnish Broadcasting Corp (YLE). So far, the number of fur farms reporting outbreaks in the country stands at 24. Culling has been ordered at 12 farms, 9 are under surveillance, and 3 are being assessed. Elsewhere, the UK Department for Environment, Food, and Rural Affairs (DEFRA) yesterday published guidance on how to keep pets safe from avian flu, which follows recent detections in cats in Poland and South Korea. The guidance urges people to keep their pets away from dead or sick wild birds, keep them under control in areas where wild birds are located, and avoid feeding pets noncommercial raw poultry meat, game bird, waterfowl, or other wild bird meat.
• The Rhode Island Department of Health today reported a fatal tickborne Powassan virus case, which involved a woman older than 80 years from Washington County, located in the southern region of the state. She experienced neurologic symptoms and died in the middle of July. The Centers for Disease Control and Prevention (CDC) confirmed the findings earlier this month. Powassan virus cases are rare but have increased in recent years. They are most common in the Northeast and Great Lakes regions. Of 239 cases reported over the past decade, 5 were in Rhode Island.