NovaDigm Therapeutics
John P. Hennessey, Jr. is the Vice President, Research & Developmentand Tim Cooke is the CEO of NovaDigm Therapeutics
How and when did your company start, and where are you located?
NovaDigm was founded in 2005 by a group of investigators at the Los Angeles Biomedical Research Institute (LA BioMed) and the Division of Infectious Diseases at Harbor-UCLA Medical Center. The company received its first venture capital funding from Domain Associates in 2008 and established its corporate headquarters and laboratory in Grand Forks, North Dakota in 2009.
How many employees do you have, and how do you find / attract them?
We have 11 full-time employees and a strong network of consultants. We have found our lab-based employees in North Dakota through local advertising and networking. Our other employees and consultants are drawn mainly from our established networks within the vaccine industry.
What are the main focus and platform technology(ies) of your company?
NovaDigm is a product-focused company based on recombinant antigens from the fungal pathogen Candida albicans that were in-licensed from LA BioMed. We are currently developing vaccines using two of these antigens, rAls3 and rHyr1. By analyzing the structure of these antigens, our scientific founders discovered structural homologies between Als3 and two surface proteins on Staphylococcus aureus and between Hyr1 and a surface protein on Acinetobacter baumannii. Subsequent studies in preclinical models demonstrated cross-kingdom protection (i.e. protection against both a fungal pathogen and a bacterial pathogen), the first reports of such broad protection for a single antigen.
Can you provide a short overview of your product pipeline?
Our lead program is the NDV-3 vaccine, containing the rAls3 protein. NDV-3 has completed two Phase 1 studies in 200 healthy adults. In July 2013 we initiated a Phase 1b/2a efficacy study of NDV-3 as a therapeutic vaccine to prevent recurrences of vaginal yeast infections in women with chronic yeast infections due to Candida (recurrent vulvovaginal candidiasis).
Who is your competition, and what advantage(s) does your products / technology offer?
The only other company with a clinical-stage Candida vaccine is Pevion, a Swiss biotech company. They are also targeting recurrent vaginal yeastinfections due to Candida as an initial indication. Pevion’s vaccine has completed an initial Phase 1 study.
However, Candida is also the third most prevalent pathogen in ICUs worldwide, and causes invasive infections that have 30-40% mortality rates. The eventual use of our vaccines to prevent these deadly nosocomial (healthcare-associated) infections is a key mission of NovaDigm. For these indications, the cross-protection of our vaccines against other major nosocomial pathogens like S. aureus and A. baumannii would be a major advantage.
What were the “highlights“ in your recent development of vaccines / immunotherapeutics?
NDV-3 demonstrated rapid and robust immune responses to rAls3 after a single dose in Phase 1 clinical studies. Nearly all vaccinees had evidence of natural pre-exposure to Als3 and all NDV-3 vaccinees had anamnestic responses to the rAls3 antigen, with peak antibody titers at 14 days post-vaccination. The responses included increases in serum and vaginal IgG and IgA titers, as well as Als3-specific activation of Th1 and Th17 T-cells. Similar responses to rAls3 were observed whether it was formulated with and without alum adjuvant, although antibody titers were 2-3-fold higher with alum.
What have been the most critical problems in developing products in your field, and how can your company’s technology help overcome these problems?
Since there have been no prior efficacy studies performed with a Candida vaccine, there are no established correlates or surrogates of protection. This imposes a limitation that leaves assessment of protective efficacy as the only valid end point for clinical evaluations. Additionally, rodent species typically used in preclinical research models are not naturally exposed to Candida and therefore do not have a pre-existing immune response to Candida as do humans. While non-human primates do not have this limitation, they are not a practical solution to this problem. The only way to address these limitations that are common for novel vaccines at this stage of development is to perform the appropriate clinical studies to generate safety, immunogencity and efficacy data. Results from our Phase 1 studies and our recently initiated efficacy study will help us to overcome these limitations.
What is your company's value proposition?
We are developing a novel vaccine targeting Candida and have additional value that can be created from the cross-protection of our antigens to the bacterial targets S. aureus and A. baumannii. We intend to develop our vaccine candidates through the Phase 2 efficacy stage and then are likely to hand off late stage development and commercialization to a company with far greater resources than NovaDigm has access to.
What business development strategy do you pursue?
NovaDigm is a product-focused rather a platform technology company. We are therefore interested in having a larger company acquire the entire product family rather than licensing out closely-related product assets.
How does your company attract partners?
The vaccine world is rather small so it it is not hard to identify the most likely industry partners that have the resources and the expertise to successfully bring our vaccines forward to the patients who need them.
Who are your most important partners?
Our most important partner continues to be LA BioMed, from whom we have in-licensed our vaccine antigens. We continue to collaborate closely with our scientific founders at LA BioMed on the development of our current and future vaccine candidates. The US National Institutes of Health and the Department for Defense are also key partners that have been providing funding and technical expertise to support our programs.
How do you balance performing work in-house vs out-sourcing?
For each activity, we assess the relative costs, risks and timing of out-sourcing versus in-sourcing on a case-by-case basis. While we have tended to out-source most of our activities, we are methodically building the expertise and capacity to bring our most important activities in-house.
What are your product development goals for the next 3 years?
We have just initiated a Phase 1b/2a efficacy study to prevent recurrences of vaginal yeast infections in women with chronic yeast infections due to Candida (recurrent vulvovaginal candidiasis or RVVC). This study is being performed with rAls3 antigen as a monovalent vaccine. In parallel, we are assessing rAls3 in combination with the rHyr1 antigen mentioned above in preclinical models. We intend to take this bivalent combination vaccine into Phase 1 evaluation as a potential second generation RVVC vaccine and as a first generation nosocomial infection vaccine targeting Candida, S. aureus and A. baumannii. This latter indication would be a very attractive vaccine candidate for potential broad protection against nosocomial pathogens.
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