Attacking Cancer with Oncolytic Virotherapeutics Bryan Dulhunty - - PowerPoint PPT Presentation

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Attacking Cancer with Oncolytic Virotherapeutics Bryan Dulhunty - - PowerPoint PPT Presentation

Jan 29, 2023 365 likes •643 views

Attacking Cancer with Oncolytic Virotherapeutics Bryan Dulhunty Managing Director bryan.dulhunty@viralytics.com | www.viralytics.com | Listed on the Australian Stock Exchange: VLA and OTC: VRACY Todays discussion 1. The exciting frontier of

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Attacking Cancer with Oncolytic Virotherapeutics

bryan.dulhunty@viralytics.com | www.viralytics.com | Listed on the Australian Stock Exchange: VLA and OTC: VRACY

Bryan Dulhunty Managing Director

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  • 1. The exciting frontier of Oncolytic Virotherapeutics
  • 2. The Viralytics story

I.

Our development

II.

Our lead drug - CAVATAK™

III.

Clinical development

IV.

Management and financial resources

bryan.dulhunty@viralytics.com | +61433 217876

Today’s discussion

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  • 1. The exciting frontier of

Oncolytic Virotherapeutics

bryan.dulhunty@viralytics.com | +61433 217876

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What is Virotherapeutics

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

bryan.dulhunty@viralytics.com | +61433 217876

Coxsackievirus A21 CAVATAK™ Viralytic’s lead candidate

Adenovirus Herpesvirus Vacciniavirus Reovirus Coxsackievirus A21

Representative scales of viruses

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bryan.dulhunty@viralytics.com | +61433 217876

Can a virus be used to treat cancer?

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

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Drivers of Virotherapeutics

  • Strong scientific research
  • Quality clinical trial data
  • Commercial investment

bryan.dulhunty@viralytics.com | +61433 217876

Pushing the Virotherapeutics frontier

2005 2006 2007 2008 2009 100 200 300 400

Exponential increase in scientific papers published

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Company Product, Virus Ownership Commercial Value/Deals Stage of Development Biovex Inc (USA) OncoVEX herpes 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) REOLYSIN Reovirus Publically Listed - NASDAQ US $450 m Market Capitalisation Phase III: Head and Neck cancer Jennerex (USA) JX-594 Pox virus Private US $116 m European rights licensing development deal 2010 Phase II: Liver cancer Viralytics (Australia) CAVATAK™ Coxsackievirus EVATAK™ Echovirus Publically Listed - ASX US $50million Market Capitalisation Phase II: Melanoma impending US Trial. Phase I: Melanoma, Breast, Prostate, Gioblastoma

bryan.dulhunty@viralytics.com | +61433 217876

Virotherapeutics in development

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  • 2. The Viralytics story

bryan.dulhunty@viralytics.com | +61433 217876

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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

bryan.dulhunty@viralytics.com | +61433 217876

2005 2011 2006 2008

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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

bryan.dulhunty@viralytics.com | +61433 217876

Viralytics’ Oncolytic Viruses

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bryan.dulhunty@viralytics.com | +61433 217876

Our pipeline - more than melanoma

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  • Trademarked name of Coxsackievirus A21
  • Enterovirus forming part of the common cold family of viruses
  • Has not been genetically altered
  • 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

  • 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 - CAVATAK

TM

bryan.dulhunty@viralytics.com | +61433 217876

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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.

bryan.dulhunty@viralytics.com | +61433 217876

Mode of action

1 2 3

CAVATAK

3 2 1

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“This is probably the lowest dose

  • f virus administered that has had

therapeutic benefit in an animal model that I have seen published” Professor Bell Virotherapy paves the way for new cancer treatment Lancet Oncology

Vol 5, No. 3 2004 p135-196

bryan.dulhunty@viralytics.com | +61433 217876

Oncologist endorsement of CAVATAK™

CAVATAK

TM

saline

Intravenous Intratumoral

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Intratumoral delivery Melanoma

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

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

  • Phase II USA trial - FDA approval pending. 63 patient intratumoural trial,

multiple tumours, multiple injections Head and Neck

  • Ongoing Phase I trial

Intravenous delivery

  • Ongoing Phase I trial - solid tumour cancers - prostate, breast & melanoma
  • III. Clinical development

bryan.dulhunty@viralytics.com | +61433 217876

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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 flattening b) 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)

bryan.dulhunty@viralytics.com | +61433 217876

Phase 1 melanoma trial results

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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.

bryan.dulhunty@viralytics.com | +61433 217876

IND allowed Phase II CALM study

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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

  • f CAVATAK™ in USA.

bryan.dulhunty@viralytics.com | +61433 217876

Corporate overview

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PCT/AU2000/001461

A 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/AU2003/001688

A 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/AU2005/000048

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

PCT/AU2005/001257

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

PCT/AU2006/000051

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

bryan.dulhunty@viralytics.com | +61433 217876

Worldwide patent coverage

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Board Mr Paul Hopper | Chairman - US based director of NASDAQ listed Biotechs with extensive capital markets experience in US and Asia Dr Phillip Altman | extensive clinical trial background having established his own clinical research organization Mr Peter Molloy | prior MD of Biota Inc., ex large pharmaceutical executive - VP Strategic Marketing for Pharmacia Management Mr Bryan Dulhunty | Managing Director, long term capital intensive project specialist Professor Darren Shafren | CSO and Inventor of Technology

bryan.dulhunty@viralytics.com | +61433 217876

  • IV. Management & financial resources
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Scientific Advisory Board Current SAB to be significantly strengthened through recruitment of internationally recognised members. Announcement to be made shortly. Collaborations International clinical collaborations are being formed to pursue clinical research of CAVATAK™ use with bladder, lung and pancreatic cancers.

bryan.dulhunty@viralytics.com | +61433 217876

Management capabilities

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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

bryan.dulhunty@viralytics.com | +61433 217876

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Phase II Intratumoral trial US$5m Phase II Intravenous trial US$5m Scientific and clinical collaborations US$3m Development of EVATAK virus US$2m Ongoing research US$3m Corporate activities US$3m Total estimated 3 year spend US$21m

bryan.dulhunty@viralytics.com | +61433 217876

Forecast funding needs - 3 years

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Market need

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

CAVATAK™ meets that need

  • Potential for effective treatment in many cancers
  • Potential for a well tolerated product with minimal side effects

Pivotal timing

  • Biovex (Phase III trial underway) acquired by Amgen for c.$US1B
  • Nasdaq listed Oncolytic Biotech (in Phase III trial) - market cap $US450m
  • Viralytics to commence Phase II USA trial - market cap $US60m

bryan.dulhunty@viralytics.com | +61433 217876

Very strong reasons to invest

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Clinical Development

  • Phase 2 Trial - The CALM study - Commencing international

efficacy study of CAVATAK™ for Late Stage Melanoma

  • Completing Phase 1 Head and Neck Trial
  • Completing Phase 1 Breast, Prostate & Melanoma trial
  • Developing pipeline for demonstrating the use of CAVATAK™ to

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

  • Develop opportunities based on growth of Virotherapy and Viralytics

Resources

  • Secure intellectual property, strong management team

bryan.dulhunty@viralytics.com | +61433 217876

Summary

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  • Mr. Bryan Dulhunty

Managing Director & CEO Mobile: +61 2 433 217 876 Phone: +61 2 9988 4000 Email: viralytics@viralytics.com Web: www.viralytics.com

bryan.dulhunty@viralytics.com | +61433 217876

Contact