New Zealand’s GMO releases - EPA · New Zealand’s GMO releases: Oncolytic viruses for cancer...
Transcript of New Zealand’s GMO releases - EPA · New Zealand’s GMO releases: Oncolytic viruses for cancer...
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New Zealand’s GMO releases:
Oncolytic viruses for cancer
therapy clinical trials
Dr Tim Strabala, Principal Scientist, New Organisms
19 APRIL 2018
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What is the benefit to New Zealand?
As at April 2016 (Baltimore, Chicago, Billings, Knoxville); https://clinicaltrials.gov/ct2/show/NCT02562755
• About 180 new HCC cases per year in NZ
• 3X more prevalent in men than women
• 5X more prevalent in Māori men than non-Māori
• 3X more prevalent in Māori women than non-Māori
PHOCUS trial (Sponsor – SillaJen)
• Global Phase 3 clinical trial
Why New Zealand?
• Rapid environmental assessment pathway
allowed two New Zealand sites to be
among the first six sites to commence
Pexa-Vec phase 3 trials for HCC1 (Now
more than 100 around the world)
Pexa-Vec: New Zealand’s first GM cancer therapy approval
EPA approved October 2015, followed by Medsafe approval
Trial commenced January 2016
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Variola (smallpox) virus Vaccinia virus
• Used to vaccinate against
smallpox (cross-protective)
• Administered to 100s of
millions of people
• Infection causes smallpox
• High mortality rate
• Global vaccination
programme eradicated
variola in 1980
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Kim et al. (2006) Mol. Therapy 14:361
4 Pexa-Vec
• A GM, viable vaccinia virus
• Disrupted thymidine kinase gene (selective
growth in cancer cells)
• Insert contains immune-stimulating genes, and
a “reporter” gene
• Conditional approval for clinical trials on liver
cancer
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Hernandez-Gea et al. (2013) J. Hepatology 59:882
7Selective replication and tumour killing
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8 Human adenovirus 5
• “The common cold”
• Among the most
common human
adenovirus types
• Most people have immunity
by age 5-7
• HAd-5 vectors used
extensively in gene therapy,
cancer therapy
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9 Telomelysin
• A GM, viable adenovirus
• Changed regulation of early viral gene
expression
• No genes changed in the virus
• Virus replication is dependent on a protein
found at high levels in cancer cells
• Conditional approval for inoperable
melanoma
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Oncolys Biopharma website
10Selective replication and oncolysis
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For more information contact:
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Phone +64 4 916 2426 Fax +64 4 914 0433