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When Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) was founded in 2016, the early-stage antibiotic pipeline was stalled.

Since its inception, CARB-X has supported 115 R&D projects in 14 countries, and CARB-X product developers have made significant progress.

Recently, CARB-X awarded Baxiva AG $3 million to develop its multivalent glycoconjugate vaccine to prevent extraintestinal pathogenic Escherichia coli (ExPEC) infections.

Baxiva's proprietary conjugation platform streamlines the development of multivalent vaccines targeting the serotype-specific polysaccharides of Gram-negative bacteria, including capsule and O antigens.

The multivalent vaccine targets the most common serotypes associated with invasive ExPEC infections.

Multivalent vaccines are designed to prevent infections caused by multiple strains or types of a single pathogen. The glycoconjugate formulation combines polysaccharide (sugar) from a pathogen's surface with a carrier protein to enhance immune response and therefore the effectiveness of the vaccine.

Escherichia coli is the leading cause of urinary tract infections, a frequent cause of neonatal sepsis, and is among the leading causes of antimicrobial resistance-associated deaths globally.

"Vaccines are a powerful tool in the global effort to prevent infections and curb the spread of antimicrobial resistance," said Erin Duffy, PhD, R&D Chief of CARB-X, in a press release on August 21, 2025.

"Baxiva's multivalent glycoconjugate vaccine project explores a range of novel polysaccharide antigens in vaccine candidate solutions, addressing a critical unmet need in infection prevention."

"We are excited to welcome Baxiva into the CARB-X portfolio and support the advancement of their platform."

The E. coli bacteria cause most urinary tract infections (UTIs).

As of August 2025, UTI vaccines are unavailable in the United States.

The U.S. National Institute of Allergy and Infectious Diseases has initiated a Phase 1 clinical trial for a new ferritin-based nanoparticle vaccine aimed at preventing infection by Epstein-Barr virus (EBV).

Since May 2025, this study has been conducted at the National Institutes of Health Clinical Center in Maryland, and began to evaluate the safety of a 3-dose vaccination regimen of an adjuvanted EBV gH/gL/gp42-ferritin nanoparticle vaccine with or without gp350-ferritin, with 750 participants. 

This represents a significant milestone in the development of an EBV vaccine, as there is currently no FDA-approved vaccine available for this virus.

The U.S. CDC states most people will get infected with EBV in their lifetime, especially in childhood, and will not have symptoms. EBV is known to cause infectious mononucleosis and has been associated with several autoimmune diseases and cancers.

According to a NIH media release in 2022, "A vaccine that could prevent or reduce the severity of infection with the Epstein-Barr virus could reduce the incidence of infectious mononucleosis and might also reduce the incidence of EBV-associated malignancies and autoimmune diseases," said NIAID Director Anthony S. Fauci, M.D.

According to ClinicalTrials.gov, this study's expected completion date is October 2027.

Valneva SE announced today that it continues co-developing VLA15, a Phase 3 vaccine candidate, the only Lyme disease program in late-stage clinical development.

VLA15 is a multivalent recombinant protein vaccine that targets six serotypes of Borrelia, representing the most common serotypes found in the United States and Europe.

On August 12, 2025, Valneva confirmed its development partner, Pfizer Inc., is currently executing the randomized, placebo-controlled Phase 3 field efficacy study. The participants will be monitored for the occurrence of Lyme disease cases until the end of the 2025 Lyme disease season in the U.S. (end of October), with topline data expected as soon as all Lyme disease cases are confirmed.

In a press release, Valneva wrote that Pfizer aims to submit a Biologics License Application to the U.S. Food and Drug Administration and a Marketing Authorization Application to the European Medicines Agency in 2026, subject to positive Phase 3 data.

Lyme disease is the most common tickborne disease in the United States and Europe.

Lyme disease remains an expanding health risk in the U.S. It is a bacterial illness transmitted to humans through the bite of infected ticks. These ticks become infected by feeding on animals that carry the bacteria in their blood.

Over 89,000 cases of Lyme disease were reported to the U.S. CDC by state health departments and the District of Columbia in 2023. Recent estimates using other methods suggest that approximately 476,000 people may be diagnosed and treated for Lyme disease each year in the U.S.

The incidence of Lyme disease in Europe is highest in the Scandinavian and Baltic states in northern Europe and Austria, the Czech Republic, Germany, and Slovenia in central Europe.