Attacking cancer with oncolytic virotherapeutics - Viralyticsviralytics.com/media/download_gallery/2011-06-17 USA Presentation... · US $116 m. European rights ... tolerated: no SAEs

Attacking Cancer withOncolytic Virotherapeutics

[email protected] | www.viralytics.com | Listed on the Australian Stock Exchange: VLA and OTC: VRACY

Bryan DulhuntyManaging Director

1. The exciting frontier of Oncolytic Virotherapeutics2. The Viralytics story

I. Our developmentII. Our lead drug - CAVATAK™III. Clinical developmentIV. Management and financial resources

[email protected] | +61433 217876

Today’s discussion

1. The exciting frontier of Oncolytic Virotherapeutics


What is Virotherapeutics

The treatment of cancer by infecting cancer cells with viruses, resulting inthe destruction of cancer cells while leaving other cells undamaged.


Coxsackievirus A21 CAVATAK™ Viralytic’s lead candidate

AdenovirusHerpesvirusVacciniavirus Reovirus Coxsackievirus A21

Representative scales of viruses


Can a virus be used to treat cancer?

The world’s largest biotechnology company certainly believes so with its $1billion 2011 acquisition of Biovex

Drivers of Virotherapeutics o Strong scientific researcho Quality clinical trial datao Commercial investment


Pushing the Virotherapeutics frontier

2005 2006 2007 2008 20090

100

200

300

400

Exponential increase in scientific papers published

Company Product, Virus Ownership Commercial Value/Deals Stage of Development

Biovex Inc (USA)

OncoVEXherpes virus

Acquired by Amgen 2011(previously private)

US $1 billion amount Amgen paid for Biovex 2011

Phase III: Melanoma and Head & Neck cancer

Oncolytics Biotech (Canada)

REOLYSINReovirus

Publically Listed - NASDAQUS $450 mMarket Capitalisation

Phase III: Head and Neck cancer

Jennerex (USA)

JX-594Pox virus

PrivateUS $116 mEuropean rights licensing development deal 2010

Phase II: Liver cancer

Viralytics (Australia)

CAVATAK™ CoxsackievirusEVATAK™Echovirus

Publically Listed - ASXUS $50millionMarket Capitalisation

Phase II: Melanoma impending US Trial. Phase I:Melanoma, Breast, Prostate, Gioblastoma


Virotherapeutics in development

2. The Viralytics story


Acquired portfolio of virus technologies from an Australian University

Decision to commercialize Coxsackievirus A21 - trademarked CAVATAK™

CAVATAK™ receives orphan drug status from FDA

US and European patents granted for CAVATAK™

Multiple Phase I intratumoral and intravenous studies commenced in a number of cancer indications using CAVATAK™

IND approval for Phase II melanoma trial using CAVATAK™ expected imminently

I. Our development


2005

2011

2006

2008

CAVATAK™ - naturally occurring, genetically unaltered Coxsackievirus A21 targeting the ICAM -1 receptor dominant on metastatic cancer

EVATAK™ - naturally occurring, genetically unaltered echovirus type 1 targeting integrin a2b1


Viralytics’ Oncolytic Viruses


Our pipeline - more than melanoma

o Trademarked name of Coxsackievirus A21

o Enterovirus forming part of the common cold family of viruses

o Has not been genetically altered

o Infects and destroys a wide range of cancer cells (in tumors and metastases) leaving healthy cells intact. Destruction of tumor cells elicits body’s own immune response against remaining cancer cells

o Superior dosing regime provides highly concentrated dose directly to cancer as a result of CAVATAK™ size, unique exterior binding mechanism and speed of replication

II. Our lead drug - CAVATAKTM


Specific attachment & infection of cancer cell

Rapid replication of CAVATAK™

Cancer cell death

Every virus that successfully infects a cancer cell results in thousands of progeny viruses that can potentially infect and destroy more cancer cells.


Mode of action

1

2

3

CAVATAK3

2

1

“This is probably the lowest dose of virus administered that has had therapeutic benefit in an animal model that I have seen published”

Professor BellVirotherapy paves the way for new cancer treatment Lancet Oncology Vol 5, No. 3 2004 p135-196


Oncologist endorsement of CAVATAK™

CAVA

TAKTM

salin

e

Intravenous Intratumoral

Intratumoral deliveryMelanomao Phase I Australian trial in single dose studies completed. Safe, well

tolerated: no SAEs reported. 57% experienced reductions in injectedtumour volume or stabilisation following multiple single injections. 2 patients displayed stable disease (RECIST 1.0)

o Phase II USA trial - FDA approval pending. 63 patient intratumoural trial, multiple tumours, multiple injections

Head and Necko Ongoing Phase I trial

Intravenous delivery o Ongoing Phase I trial - solid tumour cancers - prostate, breast & melanoma

III. Clinical development


Injected Tumour Response

Trial X01/X02(n=5)

Trial X-03(n=6)

% Patients

Reduction 2a 3b 35.7

Stable 1c 2c 21.4

Progressive 2d 4d 42.9

Reduction + Stable 57.1

a) Reduction=decrease in longest diameter ≥20% (calipers) or visual tumour flatteningb) Reduction= transient decrease in volume ≥25% (ultrasound)c) Stable= decrease in tumour volume of <25% or <20% increase in tumour volume (ultrasound)d) Progressive= increase in tumour volume of >20% (ultrasound)


Phase 1 melanoma trial results

To investigate CAVATAK™ for the treatment of Late Stage Melanoma.

IND application to the USA FDA submitted. Considering other countries for study.

Site selection for study has commenced. Recruitment in the US will begin once the study is approved by the FDA.


IND allowed Phase II CALM study

Listed - on the Australian Stock Exchange (VLA) and the OTC market (VRACY). One of two publicly traded Virotherapy companies in the world

Head Office - Sydney

Research & Operations - Newcastle University, Australia

Manufacturing - cGMP manufacture of CAVATAK™ in USA.


Corporate overview

PCT/AU2000/001461A Method of Treating a Malignancy in a Subject and a Pharmaceutical Composition for Use in the Same.Granted: Australia, Europe, USA Pending: Canada, Japan, NZ Divisional Granted: Australia Divisional Pending: Australia, Europe, USA

PCT/AU2003/001688A Method of Treating a Malignancy in a Subject via Direct Picornaviral-Mediated Oncolysis.Granted: Australian, India, NZ, Singapore, South Africa, USA Pending: Canada, China, Europe, Japan, South Korea, Hong Kong Divisional Granted: India Divisional Pending: USA

PCT/AU2005/000048Modified Oncolytic Viruses.Granted: South Africa Pending: Australia, Hong Kong, India, Japan, New Zealand, USA

PCT/AU2005/001257Methods and Compositions for Treatment of Hematologic Cancers.Pending: Australia, Canada, China, Europe, Hong Kong, India, Japan, NZ, Singapore, South Africa, South Korea, USA

PCT/AU2006/000051Method and Composition for Treatment of Neoplasms.Pending: Australia, China, Europe, Hong Kong, India, USA


Worldwide patent coverage

BoardMr Paul Hopper | Chairman - US based director of NASDAQ listedBiotechs with extensive capital markets experience in US and Asia

Dr Phillip Altman | extensive clinical trial background havingestablished his own clinical research organization

Mr Peter Molloy | prior MD of Biota Inc., ex large pharmaceuticalexecutive - VP Strategic Marketing for Pharmacia

ManagementMr Bryan Dulhunty | Managing Director, long term capital intensiveproject specialist

Professor Darren Shafren | CSO and Inventor of Technology


IV. Management & financial resources

Scientific Advisory BoardCurrent SAB to be significantly strengthened through recruitment ofinternationally recognised members. Announcement to be madeshortly.

CollaborationsInternational clinical collaborations are being formed to pursueclinical research of CAVATAK™ use with bladder, lung and pancreaticcancers.


Management capabilities

Market Capitalisation US$60m

Share Price US$0.11

Cash on Hand US$5.6m

Burn Rate - historical US$3.5m p.a.

Shares on Issue 587m

Shareholders 5,700

Financials

A stable company here for the long term


Phase II Intratumoral trial US$5mPhase II Intravenous trial US$5mScientific and clinical collaborations US$3mDevelopment of EVATAK virus US$2mOngoing research US$3mCorporate activities US$3mTotal estimated 3 year spend US$21m


Forecast funding needs - 3 years

Market needo Very large unmet need and growing demando Market is looking for more effective products with fewer side effects

CAVATAK™ meets that needo Potential for effective treatment in many cancerso Potential for a well tolerated product with minimal side effects

Pivotal timingo Biovex (Phase III trial underway) acquired by Amgen for c.$US1B o Nasdaq listed Oncolytic Biotech (in Phase III trial) - market cap $US450mo Viralytics to commence Phase II USA trial - market cap $US60m


Very strong reasons to invest

Clinical Developmento Phase 2 Trial - The CALM study - Commencing international

efficacy study of CAVATAK™ for Late Stage Melanomao Completing Phase 1 Head and Neck Trialo Completing Phase 1 Breast, Prostate & Melanoma trialo Developing pipeline for demonstrating the use of CAVATAK™ to

treat a wide range of cancers – to extend life & improve the quality of life

Licensingo Develop opportunities based on growth of Virotherapy and Viralytics

Resourceso Secure intellectual property, strong management team


Summary

Mr. Bryan DulhuntyManaging Director & CEO

Mobile: +61 2 433 217 876Phone: +61 2 9988 4000Email: [email protected]: www.viralytics.com


Contact

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Attacking cancer with oncolytic virotherapeutics - Viralyticsviralytics.com/media/download_gallery/2011-06-17 USA Presentation... · US $116 m. European rights ... tolerated: no SAEs