Positive data from NovaDigm's NDV-3 vaccine preclinical study on VVC

NovaDigm Therapeutics, a company developing innovative vaccines for fungal and bacterial infections, today announced the presentation of positive data from a preclinical study evaluating the efficacy its NDV-3 vaccine in a model of vulvovaginal candidiasis (VVC), which is primarily caused by Candida albicans. The results were presented at the 51st Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). NDV-3 is a prophylactic vaccine being developed for Candida and Staphylococcus aureus (including methicillin-resistant S. aureus, or MRSA), and recently completed a Phase 1 trial evaluating its safety and immunogenicity. NDV-3 is the first vaccine to demonstrate preclinical "cross-kingdom" protective efficacy against both fungal and bacterial pathogens.

The study concluded that vaccination with NDV-3 induced potent, protective immune responses against VVC that were characterized by high anti-NDV-3 antibodies. These immune responses led to decreases in vaginal fungal burden. The study found that the mechanism of protection elicited by NDV-3 against VVC was mediated by both T-cells and B-cells.

"This preclinical efficacy data for NDV-3 in a specific fungal disease indication further supports prior preclinical data, and also complements the positive immune response activity that NovaDigm recently reported from the Phase 1 trial for this vaccine," said Timothy Cooke, Ph.D., NovaDigm's Chief Executive Officer. "NDV-3 holds significant promise as a vaccine against VVC, which is one of the potential indications that NovaDigm is pursuing for this program."