Viralytics traces its beginnings to research conducted by Darren Shafren, Ph.D., Associate Professor of Virology at the University of Newcastle who, with his team, first developed a proprietary formulation of the oncolytic virus, Coxsackievirus A21 (a form of common cold) for potential use as a cancer treatment. Based on this work, the company was founded with a focus on investigating oncolytic viruses in a range of cancer types such as melanoma, lung, breast, prostate, ovarian, colorectal, and lymphoid cancers.
Encouraging Clinical Trials
The first Phase 1 clinical trial of Coxsackievirus A21, trademarked CAVATAK®, was conducted in patients with end-stage melanoma. We were later granted orphan drug designation from the FDA for the treatment of late stage melanoma. Results of our first-in-man studies were encouraging. Additional Phase 1 clinical trials designed to evaluate different doses of CAVATAK given intra-tumourally as well as intravenously were then conducted in a number of indications. Data Safety Committee reports demonstrated no significant product-related safety concerns, and approval to proceed to higher dosing levels was granted at each stage of the process. The company at this stage secured the services of a US based GMP compliant contract manufacturer specialising in virus manufacture to produce CAVATAK.
In 2011 the FDA granted Viralytics an Investigational New Drug (IND) application for a Phase 2 clinical trial evaluating CAVATAK administered intra-tumourally to patients with late-stage melanoma. Known as the CALM study (CAVATAK in Late stage Melanoma), this trial achieved its primary endpoint ahead of schedule in September 2013 and is now complete. Further information can be found on the CALM Clinical Trial page.
Viralytics is now progressing a number of trials of CAVATAK in combination with other agents in patients with melanoma, lung and bladder cancer. This includes a collaboration with Merck & Co., Inc., Kenilworth, New Jersey, U.S.A. (known as MSD outside the United States and Canada) utilising KEYTRUDA in combination with CAVATAK in Non Small Cell Lung Cancer and Bladder Cancer patients. Full details of this and other combination trials can be found at our Clinical Trials page.
Results from all our trials have been presented at major global oncology conferences in recent years, including the American Society of Clinical Oncology (ASCO) and the American Association of Cancer Research (AACR). Further information can be found at our Scientific Presentations page.
Positioned for Growth
In 2014 and 2016 Viralytics completed two substantial capital raises introducing a significant and high quality institutional presence to our register. As of late 2016 US based specialist healthcare funds held approximately one third of the company’s shares on issue. These transactions provided further validation of the therapeutic and commercial potential of CAVATAK and give the company the financial security to fund its trial programme and explore other indications and combination strategies.
We continue to evaluate strategies for development of our clinical programme in order to establish the best path to market for CAVATAK. Extensive preclinical work continues to assess the best possible candidates for future development. Details can be found on our preclinical studies page.
Viralytics looks forward to an exciting future as we aim to create new and better treatment options for patients with cancer.