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
Since 2014 Viralytics has completed substantial capital raises introducing a significant and high quality institutional presence to our register, with institutional investors now holding approximately one half of the company’s shares on issue. In January 2018 Lepu Medical Group, a leading Chinese Life Sciences conglomerate, took a 13% stake in Viralytics through a private placement, paying a premium to the prevailing market value of Viralytics shares. In February 2018 Viralytics and MSD (Trade name of Merck & Co. Inc) announced a Scheme of Arrangement in which the board of directors unanimously recommended a bid by MSD to acquire 100% of shares in the company. Subject to the vote of shareholders and successful completion of the scheme, Viralytics will become a subsidiary of MSD in June 2018.
Viralytics continues to progress the clinical and pre-clinical programmes under the Scheme of Arrangement. The strategic direction of those programmes will be controlled by MSD upon successful completion of the Scheme.
Viralytics looks forward to an exciting future as we aim to create new and better treatment options for patients with cancer.