NovaDigm Therapeutics, a company developing innovative vaccines for fungal and bacterial infections, today announced the publication of data from its first-in-human Phase 1 study of its NDV-3 vaccine program in the journal Vaccine. The data demonstrate that a single dose of NDV-3 with alum adjuvant was safe, well-tolerated and induced strong antibody and T-cell immune responses in healthy adults.
NDV-3 is a vaccine being developed for the treatment and prevention of infections caused by the fungus Candida and the bacterium Staphylococcus aureus (including methicillin-resistant S. aureus, or MRSA). NDV-3 is the first vaccine to demonstrate preclinical "cross-kingdom" protective efficacy against both fungal and bacterial pathogens.
"The publication of this positive data provides further validation for NovaDigm as we prepare to begin a Phase 2 efficacy study with an optimized vaccine formulation in the first half of 2013," said Timothy Cooke, Ph.D., NovaDigm's Chief Executive Officer. "We are encouraged that NDV-3 was shown to be safe and well-tolerated, with a very promising immunogenicity profile, in two Phase 1 studies. We are confident that it can play an important role in treating community- and hospital- acquired infections caused by these pathogens, which represent significant medical needs and large commercial potential."
"There is a great need for vaccines that can safely treat the wide array of infections caused by both Candida and Staph aureus," commented John Hennessey, Ph.D., corresponding author of the study and Vice President of Research & Development at NovaDigm. "In addition to the rapid antibody responses following a single dose, there were also substantial T-cell responses. These included responses to Th1 and Th17 T-cells, which are believed to be important for protection against both Candida and Staph aureus. This study is also the first to demonstrate vaccine-induced Th17 responses in humans."
The objectives of this first-in-human Phase 1 clinical trial were to evaluate the safety, tolerability and immunogenicity of NDV-3 at two different antigen levels compared to a saline placebo. Forty healthy, adult subjects were randomized to receive NDV-3 containing either 30 µg or 300 µg of the Als3 antigen with alum adjuvant or placebo. The trial data published in Vaccine indicated that NDV-3 was safe and well-tolerated after one or two doses, with the most common adverse event being injection site pain that was typically mild and lasted 1 to 2 days after vaccination.