Calgary’s Oncolytics Biotech grew out of discoveries made in the 1990’s in the Department of Microbiology and Infectious Diseases at the University of Calgary. The Company’s Reolysin, a formulation of reovirus, a family of viruses that can affect the gastrointestinal system and have shown to have oncolytic, or cancer killing properties, is about to enter Phase 3 trials. Recently, Cantech Letter’s Nick Waddell talked to Dr. Brad Thompson, Oncolytics President and CEO.
For our readers that are unfamiliar, what is reovirus and what are the possibilities for its use in cancer treatments?
Reovirus is a virus naturally found in mammalian respiratory and bowel systems. Most people have been exposed to reovirus by adulthood, but the infection does not typically produce symptoms. Reovirus was noted to be a potential cancer therapeutic when early studies suggested it reproduces well in certain cancer cell lines. It has since been shown to replicate specifically in cells that have an activated Ras pathway (a characteristic that may play a role in more than two thirds of all human cancers and in most metastatic disease), while leaving healthy cells that do not have active Ras pathways unharmed. This suggests that REOLYSIN®, a proprietary formulation of human reovirus, may be an effective therapeutic for many Ras-activated tumor types and potentially for some cell proliferative disorders.
Oncolytics’ technologies are based on discoveries made in the 1990s in the Department of Microbiology and Infectious Diseases at the University of Calgary. Do you feel the biotech work being done in Canadian Universities is important enough to support financially, even if there is no immediate financial benefit?
Absolutely. Pharmaceutical companies continue to look to biotech companies for novel technologies and products to help fill their pipelines and support long-term growth. A fair number of these projects originate in Canadian Universities. I believe that the long-term benefits that may come from such discoveries far outweigh the initial start up and funding challenges.
Can you tell us a bit about your partnership with the Gynecologic Oncology Group?
The Gynecologic Oncology Group (GOG) intends to conduct a randomized Phase II trial of weekly paclitaxel versus weekly paclitaxel with REOLYSIN® in patients with persistent or recurrent, ovarian, fallopian tube or primary peritoneal cancer. The study will be Oncolytics’ second randomized study and will be sponsored by the Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, U.S. National Cancer Institute (NCI), under its Clinical Trials Agreement with Oncolytics. Partnerships like these allow us to cost-effectively expand our clinical program allowing us to look at indications we might not have the resources to be able to address on our own. We have partnerships with a number of groups including the GOG, NCI and the Cancer Therapy & Research Center at the University of Texas Health Science Center.
Oncolytics was formed in 1998 and you are currently conducting a phase III trial for head and neck cancer. If all goes to plan, how long before we see REOLYSIN® on the market?
The Phase III trial for head and neck cancers is designed to enroll 80 patients in the first stage of the trial. The second stage is adaptive, and is designed to enroll between 100 and 400 patients, depending on what we see in the first stage. The range in the number of patients that will be enrolled in the second stage will affect the time to trial completion. Taking this into consideration, along with the time required for regulatory submission and review, we anticipate REOLYSIN® is still at least a couple of years from the market.
Needless to say, curing cancer is the Holy Grail for any biotech company, but just how big is the immediately addressable market for REOLYSIN®?
The value of the head and neck cancer market is in the US$300 to US$500 million globally and we believe REOLYSIN® can address a significant portion of this market. That said, REOLYSIN® is involved in multiple Phase I and II studies in other cancer indications, many with billion dollar plus markets, so there is the potential to substantially expand the total addressable market for the product.
You just announced a CDN $25 million bought deal financing. Where does this level of funding take you?
On closing we ended up raising gross proceeds of $28.77 million as the underwriters elected to fully exercise their overallotment option. The capital we raised in the financing will fully fund the Phase III combination REOLYSIN® and paclitaxel/carboplatin clinical trial for patients with platinum-failed head and neck cancers. This trial is significant because it is the first pivotal study we are conducting and, if successful, will form the basis for our submission to regulatory authorities in multiple jurisdictions. The remainder of the funds will be put towards other REOLYSIN® clinical development programs, which could ultimately help expand our addressable market, and for the manufacture of clinical REOLYSIN® supply.