Oncolytics Biotech Inc. (ONCY)

[onco_investor]

BioScience World - Building a cancer treatment from a virus: Matt Coffey Chief Operating Officer Oncolytics Biotech Inc.

http://www.biotechfocus.com/BuildingacancertreatmentfromavirusMattCoffeyChiefOperatingOfficerOncolyticsBiotechInc

Compiled by Shawn Lawrence

Chemotherapy as any cancer patient will tell you isn’t for the faint of heart but it can kill many forms of cancer. Some forms of chemotherapy, originally
discovered as a cancer treatment almost 70 years ago, are still routinely prescribed for most types of the disease.

The treatment works by targeting fast-growing cells, like those typically found in rapidly growing tumours. But while chemotherapy can shrink tumours, they often grow back and become resistant, or refractory to the treatment.

To combat this resistance, chemotherapy is now often used in combination with other treatments that have different mechanisms for attacking and killing cancer cells.

Doctors must be cautious when combining treatments to ensure that the regimen doesn’t become too toxic for patients to tolerate. The goal is to introduce drugs that can be used synergistically with chemotherapy to not only extend life, but to improve quality of life while undergoing treatment.

One such complimentary drug may be Reolysin, a naturally occurring reovirus developed by Calgary-based Oncolytics Biotech Inc. The treatment is a virus that doesn’t make humans sick, preferentially it replicates in cancer cells with an activated RAS pathway and spares normal cells. The cancer’s Oncolytics has targeted with this reovirus are mostly solid-tumour cancers that have a tendency to spread or metastasize.

Matt Coffey, chief operating officer and co-founder of Oncolytics Biotech Inc. has been with the company every step of the way, from the initial discovery of the product at the bench, to the launch of the company with the help of CEO Brad Thompson, and now as the company prepares to launch its Phase III trial. The planned human trial will assess the intravenous administration of Reolysin with the chemotherapy combination of paclitaxel and carboplatin vs. chemotherapy alone.

The unique part explains Coffey is that it is a cancer treatment built on a virus with no known associated disease.
“Reoviruses are found everywhere in nature and have been isolated from untreated sewage, river and stagnant waters.

Exposure to reovirus is common in humans, with half of all children by the age of 12 having been exposed, so it’s not something new. In terms of the actual product, it is a double-stranded RNA non-enveloped virus that is able to replicate in the cytoplasm and therefore does not integrate into the cell’s DNA,” he explains. “Approximately two thirds of all cancers (including breast, ovarian and small-cell lung cancer cancers that have metastasized, or spread to other parts of the body) have an activated RAS pathway so the possibilities of Reolysin’s efficacy are endless.”

Strong synergy with existing therapies
Thus far, Reolysin has demonstrated impressive results in both clinical trials on its own, and in combination with certain chemotherapeutics. In preclinical studies of a wide variety of cancer cell lines, investigators found that when used together, reovirus and chemotherapy resulted in more efficient anti cancer activity, than when each agent was used on its own. Additionally, in human trials the combination therapy has performed well in refractory head and neck cancer patients, leading to tumour shrinkage without adverse side effects. With these clinical results, a solid manufacturing program and numerous patents approved, Oncolytics is well positioned to launch the final stage of its development of Reolysin.

“The results are so promising that we announced plans to test the treatment combination in a late-stage, pivotal trial in patients with platinum-failed head and neck cancers later this year,” Coffey said adding that Non-small cell lung cancer (NLCLC) is another potential target for this treatment combination. Oncolytics has already started patient treatment in a U.S. Phase II combination Reolysin and chemotherapy trial. The Cancer Therapy & Research Center at the University of Texas Health Science Centre-a big proponent of oncolytic viruses-committed this year to funding up to five, Phase II clinical trials using the combination against a variety of advanced cancers.

Moreover, the company recently reached its biggest milestone to date, an agreement with the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) on the design of the previously mentioned Phase III trial. The agreement is the first of its kind for an intravenously administered oncolytic virus. Shares in the company have soared since the human trial was given the ok to move forward. This is the however the most expensive phase and most important stage, and makes Coffey’s evolving role with the company all the more important. For both Coffey and the company it is the culmination of a long and arduous ten year journey.

“The thing is we weren’t trying to come up with a cancer therapeutic, it was more just following up on an interesting observation with a type two pathogen, looking at basic biology and we got lucky.

I remember thinking to myself when we made the discovery, wow, that’s interesting. It was very akin to Isaac Asimov’s belief that the most exciting phrase to hear in science, the one that heralds new discoveries, isn’t ‘eureka’, but rather ‘that’s funny’. Then the discovery was published in Science and everyone was asking where was I going to be doing my post doc, and I said well actually what I think I’m going to do is start this company. A lot of my thesis advisors felt I was giving up a golden opportunity, ‘you have a set future in academia and you’re just sort of stepping out into the great unknown, why are you doing that?”
Making the leap into the world of business and leaving behind the sheltered life of academia was only the first step; the learning curve was even more intense.

“Just trying to play catch-up in terms of the legal side of things, the regulatory side, the clinical aspects and the politics as chief scientific officer was pretty difficult. As we moved away from the basic research, I moved away from that role into the chief operating officer role and now we’re at a point that while we continue to do a lot of basic research and collaborations with universities throughout the world, things are now much more directed. I’m becoming more involved in the manufacturing aspects, defending and creating new intellectual property, interacting with potential partners at an operations level. It’s a move more towards the actual commercial aspect in the same way the product is inching closer to commercialization,” he said.

For the company, there has also been a few challenges and hurdles along the way.

Among the bigger challenges was overcoming regulators natural biases and fears against the thought of using a virus as a therapeutic.

“For ten years, we were the ugly baby of the industry, and many were concerned with the nature of the agent. You can imagine going to regulators and saying we want to give an unattenuated completely replication competent infectious disease causing vector to the terminally ill. But it was dogged determination more than anything else that helped us overcome the naysayer’s that said it wouldn’t work, you’ll never get a patent, you’ll never get a Phase 1 and you’ll never be able to use the product systemically. But here we are with SPA approval, and now everyone is saying, oh I knew it, I knew it would work. So it’s nice to see the change in the attitude,” he said.

His faith in the product has only grown stronger with every new positive result and as such he is proud to have taken what was once called “an interesting research project” to the brink of the commercialization “You don’t step into a Phase 3 unless you think you’re going to be successful. You don’t go there, you don’t want to risk patients unless you’re absolutely confident it’s going to work, and every indication is it will, I’m very firm in my belief that not just our product but this whole area of using viruses to target malignancy is going to be the next step in the treatment of not just cancer, but human disease as a whole,” said Coffey.

Its taken ten years to get to the point where people have embraced the science, and for Coffey it’s been worth the wait.

“To have taken something from an idea all the way through hundreds of patients, through the manufacturing to create an intellectual property state around it, to have it listed on Toronto and the NASDAQ.

We are the only group that has ever received special protocol assessment (SPA) for a systemically used virus. This is as far out on the edge as you can possibly be, so it’s been a gas. I think 5 or 6 years from now I’ll take a look back and think how did we even do it?”

Thanks to Hellacious_too