Print 03 October 2013
GRAND FORKS, N.D. – October 3, 2013 – NovaDigm Therapeutics, a company developing innovative vaccines for fungal and bacterial infections, today announced that it has closed a $14M Series B financing. Participating investors included new investor RusnanoMedInvest (RMI) and current investor Domain Associates. The proceeds from this financing will be used to conduct an ongoing Phase 2 clinical trial of NovaDigm’s NDV-3 vaccine in patients with recurrent vulvovaginal candidiasis (RVVC), also known as recurrent vaginal yeast infections. In addition, the company will pursue the development of additional antigens to be used in vaccines against Candida.
NDV-3 is a vaccine being developed for the treatment and prevention of infections caused by several species of the fungus Candida, including Candida albicans (yeast), and the bacterium Staphylococcus aureus (including methicillin-resistant Staphylococcus aureus, or MRSA). NDV-3 is the first vaccine to demonstrate preclinical “cross-kingdom” protective efficacy against both fungal and bacterial pathogens.
“This Series B investment will support the Phase 2 trial of NDV-3 as an active immunotherapeutic for patients with RVVC, a condition that affects approximately six percent of the female population between the ages of 16-55 and for whom there is a significant need to reduce recurrent infections,” said Timothy Cooke, Ph.D., NovaDigm’s Chief Executive Officer. “We are pleased to have Domain’s continued support and to have RMI join as a new investor at this exciting time in NovaDigm’s corporate development.”
NDV-3 Development Program
NDV-3 is a vaccine candidate containing a recombinant form of the Candida albicans surface protein Als3, which facilitates Candida adherence to and invasion of human endothelial cells. This vaccine was developed as a result of research in the labs of NovaDigm’s scientific founders at the Los Angeles BioMedical Research Institute at Harbor-UCLA Medical Center, demonstrating that several members of the agglutinin-like sequence (Als) family of proteins induce protective immunity in preclinical models. NDV-3 is the first vaccine to demonstrate protective efficacy against both fungal and bacterial pathogens. Preclinical studies have shown that NDV-3 confers a high survival rate following a challenge with highly virulent doses of Candida albicans or against one of several strains of Staphylococcus aureus, including methicillin-resistant Staphylococcus aureus (MRSA). Two Phase 1 studies involving 200 healthy adults have indicated that NDV-3 is safe, well-tolerated and induces rapid antibody and T-cell responses after a single dose, with or without alum adjuvant. This work was supported in part by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (Grant Numbers AI19990, AI063382 and AI071554) and by the Department of the Army (Award Numbers JW81XWH-10-2-0035 and W81XWH-11-1-0686).
NovaDigm is developing innovative vaccines to protect patients from fungal and bacterial infections, which can be recurrent, drug-resistant and in some cases, life-threatening. The Company’s founding scientists from the Los Angeles BioMedical Research Institute at Harbor-UCLA Medical Center (LA BioMed) are recognized leaders in the field of infectious disease and the emerging threat of “superbugs”. Their work has been largely funded by the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIH NIAID). NovaDigm’s lead product candidates target Candida, a fungal pathogen, and Staphylococcus aureus, including MRSA. Based in North Dakota with additional research activities at LA BioMed, NovaDigm has received funding from Domain Associates and RusnanoMedInvest and collaborates with multiple government agencies.
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