A vaccine for rheumatoid arthritis

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1 A vaccine for rheumatoid arthritis Professor Ranjeny Thomas Founder and Director of Dendright Pty Limited Head, Autoimmunity Division, Diamantina Institute, The University of Queensland

2 About Dendright Established 2005 as UniQuest startup >15 years study of dendritic cells in autoimmune diseases Therapeutic vaccine for rheumatoid arthritis (RA) Personally supported by Arthritis Queensland Funded by Government innovation grants Janssen collaboration announced January 2012

3 The discovery E.COLI By turning off a key molecule (NF-kB), dendritic cells can be changed to silence the immune system rather than to activate it Patent application in National Phase in major territories

4 What the product looks like

5 How did I get here? More than research: Management & leadership Organisational strategy Product development Industry engagement

6 Patent and publish UniQuest support Published January 2003 Priority date August 2002

7 Clinical translation 2003 plan to translate discovery in to proof-ofconcept Lead indication is rheumatoid arthritis But how to fund? UniQuest helped identify and obtain nontraditional funding for research

8 Clinical translation Soft funding Biotechnology Innovation Fund Innovation Start Up Scheme Dendright Pty Limited is established in 2005

9 Clinical translation Pharma & VC active pitching to: Venture capital firms Pharmaceutical companies One or more pitches to 26 different entities around the world Re-occurring themes: Don t like cell therapy Can you target to the Dendritic Cells? What s your business model?

10 Clinical translation Pivot point 1 First-in-man trial starts in 2010 after years of: pre-clinical research satisfying the TGA with toxicology studies three Ethics committees getting insurance writing the protocol (at least I was good at this)

11 Clinical translation First-in-man trial

12 Clinical translation Pivot point 2 Dendright poster describing preclinical development of tolerising dendritic cells Dr Michael Elliot Entrepreneur in Residence, Janssen R&D, USA

13 Clinical translation Plenary talk Dr Anuk Das Scientific Director, Immunology, Janssen R&D

14 Clinical translation Deal drive Kathy Connell Senior Manager, Innovation & Investment, Janssen ANZ Dr Anuk Das Scientific Director, Immunology, Janssen R&D Dr Paul Stoffels, M.D. Worldwide Chairman, Pharmaceutical Research Director & CSO, Janssen R&D Dr Michael Elliot Entrepreneur in Residence, Janssen R&D, USA

15 Innovative Rheumatoid Arthritis Therapy Receives Backing from Janssen 16 January 2012 Dendright Pty Ltd received a seed grant from Janssen-Cilag Pty Ltd in Australia Funds pre-clinical development of Dendright product as treatment for RA Dendright remains 100% owned by UniQuest Agreement facilitated by UniQuest

16 Dendright next steps Further clinical trials for RA planned Develop biomarkers for RA patient selection Second product will target type 1 diabetes

17 Critical inputs to date Clinical Have a drug candidate Clear patient need Solid science Collaboration Open and willing to engage with partners Mutual desire to help patients Corporate (UniQuest) Good corporate governance Solid patent applications Integrated management team driving industry engagement and negotiating appropriate deal terms Janssen partnership brings much more than money

18 Janssen brings much more than money Scientific input Formulation expertise Clinical trial design Demonstrated broad commitment from Janssen In the end, it means we can focus on delivering the R&D to benefit the patients

19 What I have learned? While commercialisation is a long haul, it is the only way for an idea to get to the clinic and to patients. Have persistence and the right partners involved. Prophetic vision is what creates intellectual property. This means others won t share your vision for quite a while but once they catch on it s a landslide. The school of hard knocks is OK.

20 Acknowledgements Dendright research team Dr Brendan O Sullivan Dendright co-inventor Dr Victor Argaet IP Counsel Partner, Davies Collison Cave Dr Lisa Bidwell Project Manager, Dendright Manager Innovation and Commercial Development, Diamantina Institute, UniQuest Dr Craig Belcher Chairman, Dendright Manager of Business Development, UniQuest

21 A vaccine for rheumatoid arthritis Professor Ranjeny Thomas Founder and Director of Dendright Pty Limited Head, Autoimmunity Division, Diamantina Institute, The University of Queensland

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