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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

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

Hernandez-Gea et al. (2013) J. Hepatology 59:882

7Selective replication and tumour killing

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

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

Oncolys Biopharma website

10Selective replication and oncolysis

For more information contact:

General enquiries

Phone +64 4 916 2426 Fax +64 4 914 0433

info@epa.govt.nz