NovaDigm Therapeutics, a company developing innovative vaccines for fungal and bacterial infections, announced the presentation of positive data for its NDV-3 vaccine program in a second Phase 1 study. The presentation was made at the 15th Annual Conference on Vaccine Research, sponsored by the National Foundation for Infectious Diseases and held in Baltimore, MD. NDV-3 is a vaccine being developed for the prevention and treatment of diseases caused by Candida and Staphylococcus aureus (including methicillin-resistant S. aureus, or MRSA). NDV-3 contains recombinant Als3, a surface adhesin/invasin from Candida albicans, which is the first vaccine antigen to demonstrate preclinical “cross-kingdom” protective efficacy against both fungal and bacterial pathogens. Results from the new study demonstrated that a single dose of NDV-3 with or without alum adjuvant was safe, well-tolerated and induced strong antibody and T-cell immune responses.
“The data from our second Phase 1 study confirms positive results from our initial Phase 1 study and shows that those receiving adjuvant-free NDV-3 had robust immune responses, as did those receiving NDV-3 with alum adjuvant,” said Timothy Cooke, Ph.D., NovaDigm’s Chief Executive Officer. “These results position us to begin Phase 2 efficacy studies with an optimized vaccine formulation and a Phase 1 safety database of 200 adults.”
The second Phase 1 trial was a double-blind, placebo-controlled study in 160 healthy adults evaluating the safety, tolerability and immunogenicity of a single dose of three different formulations and two routes of administration. A dose of the vaccine containing 300 µg of Als3 was administered intramuscularly with and without alum adjuvant to assess the impact of the adjuvant. In the third vaccinated group, a dose of NDV-3 containing 30 µg of Als3 was administered intradermally without alum adjuvant.
Results from the study demonstrated the safety and tolerability of NDV-3 in all three vaccinated groups compared to the saline placebo group. All three vaccinated groups showed rapid increases in serum and vaginal immunoglobulin G (IgG) and immunoglobulin A1 (IgA1) antibodies by day 7 following vaccination, which peaked at day 14. The demonstration of vaginal antibody responses to NDV-3 may be important in preventing vaginal yeast infections caused by Candida albicans, which is the objective of a planned Phase 2 efficacy study. The majority of subjects that received NDV-3 also demonstrated significant Als3-stimulated production of the T-cell cytokines IL-17A and IFN-γ between 7 and 14 days post-vaccination relative to subjects receiving placebo.
The Phase 1 data were presented in an oral presentation titled, NDV-3, a Recombinant Vaccine for Candida and Staphylococcus aureus is Safe and Immunogenic in Healthy Adults, by John Hennessey, Ph.D., Vice President of R&D for NovaDigm, on Monday, May 7, 2012 at 3:30pm in a session entitled “Vaccine Candidates: Preclinical and Clinical Studies.”
Date: May 7, 2012
Source: NovaDigm Therapeutics
Filed Under: Drug Discovery