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The Opportunity

CAVATAK® is a naturally occurring, genetically unaltered virus with potential activity in a range of cancer types and via intra-tumoural, intravesical and intravenous administration. Oncolytic viruses comprise one type of cancer immunotherapy which leverages the patient’s immune system to eliminate or slow the growth of cancerous cells. The annual global market opportunity for cancer immunotherapies is estimated at $42 billion by the year 2020, according to Credit Suisse.

Viralytics’ completed Phase 2 CALM trial demonstrated CAVATAK’s efficacy and tolerability as a single agent for patients with late-stage melanoma. Also completed is a Phase 1 trial assessing CAVATAK as a single agent and in combination with standard chemotherapy for patients with superficial bladder cancer.  CAVATAK is currently being investigated in several Phase 1b clinical trials in combination with checkpoint inhibitors for patients with advanced melanoma, lung cancer, and bladder cancer. These comprise three of the six most prevalent cancer types in the United States:

Cancer Type Rank * Estimated New Cases *

Lung

2nd

224,390

Bladder

5th

76,960

Melanoma

6th

76,380

* Year 2016 – USA National Cancer Institute

In addition to the indications in human trials, pre-clinical studies suggest potential benefit in the following cancers:

  • Breast cancer
  • Multiple myeloma
  • Pancreatic cancer
  • Malignant Glioma
  • Acute myeloid leukemia (AML) and Chronic lymphocytic leukemia (CLL)

Further clinical trials in a range of indications and combinations are under consideration.

About Non-Small Cell Lung Cancer (NSCLC)

Non-small-cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for about 85% of cases. For men, it is the most common type of cancer after prostate cancer, and for women, the most common after breast cancer, not counting skin cancer. Lung cancer (including both small cell and non-small cell) is the leading cause of cancer death among both men and women in the U.S., responsible for about 25% of all cancer deaths. Smoking is by far the leading risk factor for lung cancer, with about 80% of lung cancer deaths thought to result from smoking tobacco. Other carcinogens, such as second-hand smoke, air pollution, radon, and asbestos, have all been associated with NSCLC. Unfortunately, most cases of NSCLC are not detected until they are at an advanced, difficult-to-treat stage. Five-year survival rates for NSCLC range from 49% (early-stage disease) to less than 5% (late-stage disease). Treatment options include surgery, radiation and chemotherapy, along with newer therapeutic approaches such as targeted therapies and immunotherapy, including checkpoint inhibitors.

CAVATAK is being investigated in combination with the checkpoint inhibitor KEYTRUDA® to assess its potential to enhance the activity of that agent in NSCLC.

For more information about NSCLC, please visit:
http://www.cancer.org/cancer/lungcancer-non-smallcell/detailedguide/non-small-cell-lung-cancer-what-is-non-small-cell-lung-cancer

About Melanoma

Melanoma, the most dangerous form of skin cancer, is a potentially fatal malignant skin tumour that can grow and spread to lymph nodes and internal organs. Melanoma is caused mainly by intense, occasional UV exposure (frequently leading to sunburn), especially in those who are genetically predisposed to the disease. Almost 77,000 people are diagnosed with melanoma in the U.S. each year, according to National Cancer Institute, making it the sixth most common cancer in the country. In addition, the World Health Organization has determined that melanoma, which affects an estimated 132,000 people globally, is the fastest growing cancer type in the world. With early diagnosis, the prognosis for cancer patients is good, however only a small percentage of patients with Stage IV disease survive five years.

The CAVATAK programme is targeted at later stage melanoma patients whose treatment options are limited by problems such as drug resistance and toxicity.

For more information about melanoma, please visit:
http://www.skincancer.org/skin-cancer-information/melanoma
http://www.cancer.org/cancer/skincancer-melanoma/index

About Bladder Cancer

The most common malignancy of the urinary tract, bladder cancer is one of the most costly cancers to treat. An unmet need exists for treatments which offer fewer complications, better patient compliance and decreased healthcare costs.

Bladder cancer is the fifth most common cancer type in the US with about 77,000 new cases and 15,000 deaths each year. Globally, more than 330,000 people are diagnosed with bladder cancer annually. Bladder cancer affects three times as many men as women and occurs mainly in people over the age of 55.

Bladder cancer is initial treated with surgery (transurethral resection, or TUR) to remove the tumour; however the cancer has a tendency to recur. A common follow-up treatment is the delivery of live bacterial preparation Bacille Calmette Guerin (BCG) directly into the bladder.
CAVATAK, is being investigated in combination with the checkpoint inhibitor KEYTRUDA to assess its potential to enhance the activity of that agent in bladder cancer.

For more information about Bladder Cancer please visit:
http://www.cancer.gov/cancertopics/types/commoncancers

Viralytics Limited
Suite 305, Level 3, 66 Hunter Street
Sydney NSW 2000 Australia
T: +61 (0)2 9988 4000 F: +61 (0)2 8068 6038

© Viralytics Limited 2017
This information does not take your circumstances into account. Read the relevant ASX releases, financial reports and prospectuses before making an investment decision. Shares in Viralytics Limited, ABN 12 010 657 351, are traded on the Australian Stock Exchange (ASX:VLA) and on the over-the-counter market (OTC: VRACY).