N. gonorrhoeae causes gonorrhea, one of the most commonly reported sexually transmitted bacterial infections responsible for over 80 million new infections annually. The disease can lead to severe complications including pelvic inflammatory disease, infertility, and an increased risk of contracting HIV, while many infections go undiagnosed due to the absence of symptoms.
Furthermore, N. gonorrhoeae does not induce durable natural immunity, resulting in frequent reinfections and repeated courses of antibiotic treatment. The cycle of reinfection and antibiotic exposure has contributed to escalating antimicrobial resistance.
"Clinical management of gonorrhea is becoming increasingly complex due to rising antimicrobial resistance and limited treatment options," said Richard Alm, interim Chief of R&D at CARB-X. "AdJane's approach represents a technically grounded strategy that aims to address key challenges in generating protective immunity to reduce the infection rate of gonorrhea and slow the spread of antimicrobial resistance."
AdJane's nOMV platform, building on a completed Phase I clinical trial that demonstrated a favorable safety profile in humans, is being applied to gonorrhea through a heterologous approach. This strategy combines a broad, platform-driven antigenic background with the targeted expression of multiple highly conserved gonococcal antigens to elicit a targeted, broad-spectrum immune response to N. gonorrhoeae.
"We are delighted to join the CARB-X portfolio and grateful for the support as we advance our vision to address antimicrobial resistance through our platform," said Anita Gashi, Managing Director of AdJane. "This award recognizes the potential of our next-generation nOMV platform to address global health challenges such as gonorrhea. Our heterologous approach enables the creation of a single component vaccine construct designed to deliver both broad and targeted immune protection, while supporting streamlined development and manufacturing."
The AdJane award is a continuation of a previous CARB-X award to support the development of a vaccine to prevent gonorrhea.
When CARB-X was founded in 2016, the early-stage antibiotic pipeline was stalled. Since then, CARB-X has supported 123 R&D projects in 14 countries, and CARB-X product developers have made significant progress: 25 projects have advanced into or completed clinical trials; 14 remain active in clinical development, including late-stage clinical trials; and three products have reached the market. Additionally, at least 10 product developers with active R&D projects have already secured advanced development partnerships which can help support their clinical development after leaving the CARB-X portfolio. All CARB-X-funded product developers are contractually obligated to develop a Stewardship and Access Plan for their product, outlining strategies to ensure responsible stewardship and appropriate access in low- and middle-income countries.
CARB-X is funded in part with federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA) under agreement number 75A50122C00028 and by ...
