Viralytics is an Australian biotechnology company, listed on the Australian Stock Exchange (ASX:VLA) and is quoted on the OTC market (VRACY). Focused on developing oncolytic virotherapy for the treatment of a wide range of cancers Viralytics' headquarters are in Sydney, Australia and research and operations are in Newcastle, Australia.
Oncolytic virotherapy makes use of the cancer destroying capabilities of a range of benign viruses. The potential of oncolytic virotherapy is the ability to treat cancers more effectively and with minimum side-effects.
Viralytics lead product CAVATAK™ has now entered the global phase II stage of clinical trial development with a Phase II trial, for Late Stage Melanoma - the CALM study - having been recently given the green light from the USA Food and Drug Administration (FDA) for proceeding in the USA. Viralytics has had it's successful Investigational New Drug (IND) application allowed, enabling this trial to be commenced in the USA during 2011. The Phase II trial will investigate the effectiveness of intratumourally adminstered CAVATAK™ in the treatment of Late Stage Melanoma.
CAVATAK™, is part of the common cold family of viruses. It is naturally occurring, genetically unaltered Coxsackievirus A21. As a cancer therapy CAVATAK™ has the potential to directly target, infect, multiply within and subsequently destroy a wide range of primary and metastasized cancer cells, while leaving healthy cells intact. It works by seeking out and attaching itself to a protein that is highly expressed on cancer cells – (ICAM-1 protein). Once attached to this protein the virus is then able to insert itself into the cancer cell, replicate and literally burst the cancer cell apart. Thousands of progeny then spread and replicate this cycle of destruction. Once the cancer cells have been destroyed, tumour proteins are released into the blood which activates the body’s own immune system, identifying the tumour as foreign which enables the bodies own defences to come into play.
Viralytics' Phase I trials of CAVATAK™ have shown that the product is well tolerated in humans.
In addition to CAVATAK™, Viralytics is also investigating 4 other oncolytic viruses, Coxsackievirus A18,15,13 and ECHOvirus1 (trademarked EVATAK™) as cancer therapeutics. These could be effective as oncolytic therapeutics in their own right or could potentially be used in combination with CAVATAK™.
The Company holds granted patents in all major markets including the USA and Europe.
DRUG DEVELOPMENT PIPELINE
COMPETITOR VALUE COMPARISON:
There are approximately a dozen companies internationally investigating oncolytic viruses for virotherapy.
Most of these are conducting Phase I trial or involved with pre-clinical work. However there are 3 international companies in later stage development that demonstrate the potential commercial value of virotherapy companies.
Biovex (MA, USA)
In January 2011, Amgen acquired BioVex (a private USA based company) for US$ 1 Billion.
Biovex use a genetically modified Herpes virus. Biovex were conducting 2 Phase III clinical trials, one in late stage melanoma and the other in late stage head & neck cancer.
Oncolytics Biotech Inc.(Calgary, Canada)
Oncolytic Biotech is a NASDAQ listed company that, at the end of February 2011, had a market capitalization of approximately $US450m. Oncolytics Biotech use a naturally occurring Reovirus. Oncolytic Biotech are conducting a Phase III clincial trial in late stage head and neck cancer trial
Jennerex (CA, USA)
In September 2010, Jennerex announced that it had awarded Transgene the exclusive rights to develop and commercialize its lead oncolytic virotherapy product JX-594 in Europe, the Commonwealth of Independent States and the Middle East. Transgene paid Jennerex US$116 million in development and registration milestones as well as double digit royalties on a tiered structure. JX-594 is a genetically modified pox virus and has demonstrated anticancer activity in Phase I and Phase II clinical trials
Viralytics (Sydney, Australia)
Viralytics is running clinical trials to investigate the use of CAVATAK™ as an oncolytic virotherapy. CAVATAK™ is a natural, genetically unaltered coxsackie virus (part of the common cold family of viruses). Viralytics received approval from the FDA to use its Investigational New Drug, CAVATAKTM in a phase II trial in the USA, to investigate its effectiveness for the treatment of Late-Stage Melanoma. Phase I trials are still being carried out in Head and Neck, Melanoma, Breast and Prostate cancers. Viralytics is listed on the Australian Stock Exchange and had a market value of approximately $40m in May 2011.
The commercial value and deal values of the most active of these companies are tabulated:
| Company | Product, Virus | Ownership | Commercial Value/Deals | Stage of Development |
|---|---|---|---|---|
|
Biovex Inc (USA) |
OncoVEX herpes virus |
Aquired by Amgen 2011 (previously private) |
$US 1 billion amount Amgen paid for Biovex 2011 |
Phase III: Melanoma and Head & Neck cancer |
|
Oncolytics Biotech (Canada) |
REOLYSIN reovirus |
Publically Listed - NASDAQ |
US$ 300 million Market Capitalisation |
Phase III: Head & Neck cancer |
|
Viralytics (Australia) |
CAVATAKTM coxsackie virus |
Publically Listed -ASX |
A$ 30 million Market Capitalisation, October 2011 |
Phase II: Melanoma, impending in US. Phase I trials: Melanoma, Breast, Prostate, Gioblastoma |
|
Jennerex (USA) |
JX-594 Pox virus |
Private |
US $116 million European rights licensing development deal, completed in 2010 |
Phase II: liver cancer |
