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NovaDigm Therapeutics Announces Initiation of Phase 2a Clinical Trial of NDV-3A in Staphylococcus aureus

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Assessing the Impact of NDV-3A Vaccine on S. aureus Colonization in
Military Trainees

NovaDigm
Therapeutics
, a company developing innovative immuno-therapeutics
and preventative vaccines for fungal and bacterial infections, today
announced the initiation of a Phase 2a study evaluating NDV-3A for the
reduction of Staphylococcus aureus (S. aureus)
colonization in a high-risk population of military trainees. The study
is being conducted with the Uniformed Services University of the Health
Sciences (USU) and is enrolling U.S. Army Infantry trainees at Fort
Benning, GA. NDV-3A is the company's lead development candidate to
potentially treat antimicrobial resistant fungal and bacterial pathogens.

"Military recruits who are colonized with Staph aureus are at
increased risk for skin infections, which can manifest in various ways
including benign boils, cellulitis or more severe, invasive soft-tissue
infections. The goal of this study is to reduce colonization during
basic training with the NDV-3A vaccine," said Timothy Cooke, CEO of
NovaDigm. "Following on the results of this trial, a larger study would
be conducted to demonstrate a reduction in skin infections. We look
forward to continuing our collaboration with the Department of Defense,
which plays a critical role in the support of innovative approaches to
address antimicrobial-resistant pathogens."

Military recruits are known to be at increased risk for S. aureus colonization
and infection, attributable to a number of factors in the military
training environment that may enhance the acquisition and transmission
of S. aureus (e.g. limited access to hygiene during field
training, crowding, etc.). The development of countermeasures to treat
and prevent infections affecting medical readiness, such as those caused
by S. aureus and MRSA (methicillin-resistant S. aureus),
are an important focus for the military. NDV-3A has been demonstrated to
be both safe and highly immunogenic in healthy human volunteers.
Preclinical studies of NDV-3A have demonstrated its effectiveness in
reducing the impact of bloodstream and skin infections caused by S.
aureus
.

The investigative team has initiated enrollment for the
individually-randomized, double-blind, placebo-controlled clinical trial
to assess the safety, immunogenicity and efficacy of NDV-3A in reducing
nasal/oral acquisition of S. aureus. With a target enrollment of
approximately 400 participants, infantry trainees from four classes will
be recruited for the study, with receipt of NDV-3A occurring shortly
after arrival at Fort Benning. Follow-up visits will occur throughout
the 14-week training cycle to assess S. aureus colonization
status of study participants.

About the NDV-3A Development Program
NDV-3A is being
developed as an immunotherapy and as a preventative vaccine for
infections caused by several species of the fungus Candida,
including Candida albicans, multidrug-resistant Candida auris and
the bacterium Staphylococcus aureus, including MRSA. NDV-3A
contains a recombinant form of the Candida albicans
agglutinin-like sequence 3 (Als3) surface protein, which facilitates Candida
adherence to and invasion of human endothelial cells. Als3 has been
shown to have strong structural homology to surface proteins responsible
for adherence of S. aureus to human endothelial cells. This
finding helps to explain why NDV-3A is the first vaccine candidate to
demonstrate "cross-kingdom" protection against both fungal and bacterial
pathogens in preclinical studies. These studies showed that NDV-3A
confers significant protection compared to placebo following bloodstream
or mucocutaneous challenge with highly virulent doses of several species
of Candida or several strains of Staphylococcus aureus,
including MRSA strains. Two Phase 1 studies involving 200 healthy adults
suggested that the vaccine is well-tolerated, safe, and induces rapid
antibody and T-cell responses after a single dose, with or without alum
adjuvant. A Phase 2 efficacy study of NDV-3A versus placebo in 188
patients with recurrent vulvovaginal candidiasis (RVVC) demonstrated
that a single dose of NDV-3A resulted in an increase in the
recurrence-free rate out to 12 months and extended the time to first
recurrence for those that had a recurrence. This development program was
based on research in the laboratories of NovaDigm's scientific founders
at the Los Angeles BioMedical Research Institute at Harbor-UCLA Medical
Center. The 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,
W81XWH-11-1-0686 and W81XWH-16-C-0125).

About the Uniformed Services University of the Health Sciences:
The
Uniformed Services University of the Health Sciences, founded by an act
of Congress in 1972, is the nation's federal health sciences university
and the academic heart of the Military Health System. USU students are
primarily active duty uniformed officers in the Army, Navy, Air Force
and Public Health Service who receive specialized education in tropical
and infectious diseases, TBI and PTSD, disaster response and
humanitarian assistance, global health, and acute trauma care. A large
percentage of the university's more than 5,800 physician and 1,000
advanced practice nursing alumni are supporting operations around the
world, offering their leadership and expertise. USU also has graduate
programs in biomedical sciences, public health and oral biology
committed to excellence in research. The University's research program
covers a wide range of clinical and other areas important to both the
military and public health. For more information about USU and its
programs, visit www.usuhs.edu.

About NovaDigm
NovaDigm is developing innovative
immunotherapeutic and preventative vaccines to protect patients from
fungal and bacterial diseases, which can be recurrent, drug-resistant
and in some cases, life-threatening. NovaDigm's lead development
candidate, NDV-3A, is the first vaccine to demonstrate preclinical
efficacy in reducing the severity of disease caused by both fungal and
bacterial pathogens. NDV-3A is in Phase 2 clinical development for
recurrent vulvovaginal candidiasis (RVVC) with follow-on indications
planned for diseases associated with Candida and Staphylococcus
aureus infections
. www.novadigmtherapeutics.com

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