QSV Biologics, Ltd. and, NovaDigm Therapeutics, Inc., Sign Contract for cGMP Manufacture of Vaccine for Candidiasis & MRSA



    EDMONTON, Sept. 30 /CNW/ - QSV Biologics, Ltd (QSV), a North American
based biologics CMO located in Edmonton, Canada, and NovaDigm Therapeutics,
Inc., (NovaDigm) a Candida and Staphylococcus aureus vaccine company located
in Torrance, California, U.S.A., announced today the signing of a contract for
the process development and cGMP manufacturing of a recombinant protein
vaccine against candidiasis and Methicillin Resistant Staphylococus aureus
(MRSA). QSV will be responsible for technology transfer, process development,
scale-up and cGMP production of the phase I clinical trial material in their
commercially licensed cGMP manufacturing facility. The vaccine, invented by
NovaDigm founding scientists at Los Angeles Biomedical Research Institute (LA
BioMed), is based upon a family of highly conserved proteins found in Candida
albicans that have close structural and functional homology to proteins also
present in Staphylococus aureus. Candida and Staphylococcus are the causal
pathogens for a range of infectious, inflammatory and life-threatening
diseases, including invasive candidiasis and MRSA infections. If successful,
the NovaDigm technology would be the first vaccine to prevent infection by
both fungi and bacteria.
    Graeme Macaloney PhD, PEng, QSV President & CEO, QSV Biologics said:
"Infectious microbes like MRSA have mutated to develop alarming rates of
resistance to antibiotics. Vaccines help our immune systems fight off these
infections allowing us to ultimately defeat these serious life threatening and
debilitating diseases. NovaDigm's ingenious approach is to target proteins
that these 'bugs' always carry despite their ever-mutating nature and arm our
own immune systems to seek and destroy these proteins and hence their
associated host microbes. NovaDigm has remarkable technology in this regard
and QSV is pleased and excited to be a vital part of bringing these new
vaccines to patients."
    Tuomas Holmberg, Vice President, NovaDigm Therapeutics said: "A key
aspect of the NovaDigm vaccine development program that will bring our novel
vaccines rapidly and safely to market rests with our chosen contract
manufacturer. We have taken care in our diligence process by having a team of
highly experienced auditors (including ex-FDA inspectors) evaluate the
facilities and capabilities of QSV. Having requested proposals from 8 U.S. and
international CMOs, we are confident that we have chosen the ideal
manufacturing partner to accelerate our advancing this first and future
vaccines forward to the clinic, ultimately for the benefit of hundreds of
millions of patients. QSV has distinguished itself as being truly customer
focused as well as demonstrating flexibility and responsiveness to our needs
as a small business."

    NovaDigm Therapeutics, Inc. (www.novadigm.net), was founded in November
2005 by six NIH-funded, academic scientists from the Division of Infectious
Diseases at LA BioMed at Harbor-UCLA Medical Center. The company is currently
developing several platform technologies, the lead compound of which is a
vaccine that targets both Candida and Staphylococcus aureus. NovaDigm, in
partnership with the Los Angeles Biomedical Research Institute, has platform
technologies that are aimed at defeating infection and other diseases by
incorporating the human immune system. All of our technologies were developed
keeping in mind the enormous ability of microorganisms to adapt and survive by
developing resistance to therapies.

    QSV Biologics, Ltd. (www.qsvbiologics.com), is an international cGMP
biologics contract manufacturer (CMO) providing microbial fermentation,
mammalian and insect cell culture, and purification services. QSV's facility
has a 12 yr track-record including a commercial Establishment License suitable
for manufacturing clinical trial and commercial biologics. QSV was the sole
recipient of the prestigious international Frost & Sullivan "Customer Value
Enhancement Award" in 2005, and of "Company of the Year", by BioAlberta in
2007. QSV's clientele spans three continents and develops protein
therapeutics, monoclonal antibodies & vaccines. As a dedicated CMO with no
competing products of its own, QSV builds value for its clients by producing
quality products in a timely manner. Hence its acronym: QSV: Quality & Speed
build Value.





For further information:

For further information: Richard Hetrick, M.Sc., B.Sc., Director of
Business Development, QSV Biologics, Ltd., Ph: (780) 438-5722 Ext. 1, Email:
RHetrick@QSVBiologics.com; Tuomas Holmberg, MBA., BSc., Vice President,
Business Development, NovaDigm Therapeutics, Inc., Ph: (310) 689-6493, Email:
tuomas@speakeasy.net

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