New Zealands GMO releases: Oncolytic viruses for cancer therapy - PowerPoint PPT Presentation

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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Pexa- Vec: New Zealand’s first GM cancer therapy approval EPA approved October 2015, followed by Medsafe approval 2 Trial commenced January 2016 What is the benefit to New Zealand? • 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) As at April 2016 (Baltimore, Chicago, Billings, Knoxville); https://clinicaltrials.gov/ct2/show/NCT02562755

3 Variola (smallpox) virus Vaccinia virus • Infection causes smallpox • Used to vaccinate against smallpox (cross-protective) • High mortality rate • Administered to 100s of • Global vaccination millions of people programme eradicated variola in 1980

Pexa-Vec 4 • 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 Kim et al. (2006) Mol. Therapy 14:361

Selective replication and tumour killing 7 Hernandez-Gea et al. (2013) J. Hepatology 59:882

8 Human adenovirus 5 • “ The common cold ” • Most people have immunity by age 5-7 • Among the most • HAd-5 vectors used common human extensively in gene therapy, adenovirus types 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

Selective replication and oncolysis 10 Oncolys Biopharma website

For more information contact: General enquiries Phone +64 4 916 2426 Fax +64 4 914 0433 info@epa.govt.nz