Letting The Data Speak For Itself: Scott Cormack discusses why 2008 was a milestone year for OncoGenex

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By Shawn Lawrence

In 2003 Biotechnology Focus ran a spotlight on a Canadian cancer drug developer, OncoGenex technologies, which was then a relatively young unknown upstart out of Vancouver, BC. Co-founded by Scott Cormack and Dr. Martin Gleave, the principal inventor behind the company’s product pipeline, the two were just preparing to take the company’s lead product into Phase II. Six years later, now heading into Phase III, OncoGenex Pharmaceuticals Inc. as it is now known, has gone from an unknown entity, to grabbing national headlines with its promising data.

Beginning with a merger with Sonus Pharmaceuticals Inc. in August, 2008 marked a year of milestones for the University of British Columbia spin-off.

With all its product candidates moving progressively forward, 2009 is looking just as promising.

“We’ve had a pretty spectacular year of activity in terms of our clinical trials. So much has happened starting with the merger with Sonus in August, to launching onto the NASDAQ, and of course obtaining some amazing survival data indicating that we’re headed in the right direction,” states Scott Cormack, president and CEO of the company.

Company shares jumped Dec.3 after news that the company’s cancer-fighting drug had in a randomized study prolonged the life of those being treated for prostate cancer. It was the third Phase II clinical trial in a row that had shown positive survival results. In the preceding two tests, survival rates increased for first-line lung cancer patients, and second-line (those in their second round of chemotherapy) prostate cancer sufferers.

The median survival rate for patients who were receiving their first batch of chemotherapy (called first-line patients) was 16.9 months while the median for those who also took OncoGenex’s OGX-011 was 27.5 months. Essentially the data showed that when added to a chemotherapy combination, OGX-011 helped prostate cancer patients live about 10 months longer than if they got the chemo alone. The need is pressing as prostate cancer is the most common cancer affecting men, and the second leading cause of death of Western world’s men.

Many other things have changed with the company since we last checked in. First, it is no longer housed in the Prostate Centre. Cormack states this is more to do with both parties needing to expand and find different spaces. That said, the relationship shared between the centre and the company hasn’t changed.

“We still very much enjoy an extremely positive relationship with both the Prostate Centre and UBC. We’re an expanded family really, the business model has grown but it hasn’t changed, if anything it’s a continuation,” Cormack said.
The Prostate Centre is a research facility dedicated primarily to understanding the causes of prostate disease progression.

Its resources for discovery and research include an established human tumour tissue bank and a team of more than 100 basic and clinical researchers and support staff involved in activities from discovery to clinical trials.While the company has moved elsewhere for many of its clinical trials, it doesn’t have research labs of its own, and as such the centre remains the best place to conduct this type of research. “It’s a model that we just keep on using and clearly it’s driving a good part of our pipeline progress.”

The company also has contract research agreements with the university most of which are conducted in Dr. Gleave’s lab.

Of course OncoGenex still has license agreements with respect to the product candidates that include royalty obligations going to the university.

But much of the focus falls on its lead candidate, OGX-011, which has shown promise extending life in patients with prostate, lung and breast cancer in combination therapies with docetaxel. But that’s only the start says Cormack.

“With this drug we are reaching the gold standard measurement of prolonging lives. From our perspective, adding to the gold standard is the best way. If you look at prostate cancer patients, docetaxel is the only chemotherapy that has ever shown a survival advantage. If you use that as your baseline comparison and then you add on top of that your agent and improve the gold standard, then you’ve really made a shift in patient care, improving it.”

Cormack notes that there aren’t many prostate cancer drug candidates in late-stage development, other than candidates from Seattle-based Dendreon, Los Angeles-based Cougar Biotechnology, London-based AstraZeneca, and San Francisco-based Medivation. Add to this the high regard towards combination therapy and how prevalent clinical practice in oncology as the best way to overcome the burden in cancer, and Cormack feels he has a winning formula.

OGX-011 has its origins in work done by Gleave, himself a practicing surgeon at the prostate centre. His idea was that if you could block clusterin, a protein associated with helping tumours resist chemotherapy, the chemo would do a better job of killing cancer cells.

“It’s basically a two-hour intravenous administration that’s given once a week, depending on which chemotherapy a patient might be given. It’s very consistent with the normal practice of how patients normally get treated in any kind of hospital setting,” he said.

The company also reached another key milestone with the FDA granting fast track designation for OGX-011 in combination with docetaxel for progressive metastatc cancer. Fast Track designation is granted to products that may provide a significant improvement in the safety or effectiveness of the treatment for a serious or life-threatening disease.

“This basically means the FDA will be going on accelerated review times for us,” states Cormack adding that "they’ve been very responsive in providing appropriate guidance to ensure that the patient populations studied are appropriate and that it will give OncoGenex the most sound approval and label claim at the end of the day should the trial succeed in Phase III. And the team already knows the ins and outs of the process.”

On top of his role with the company, Dr. Gleave is a professor in the department of surgery at UBC, director of Clinical Research at the Prostate Centre at Vancouver General Hospital, and director of research for the division of urology at UBC.

The company also added Dr. Cindy Jacob as chief medical officer and vice president in an effort to augment Dr. Gleave’s skills and give the company the development experience needed to successfully register a drug in oncology with the FDA.

During her six years at Corixa, her team obtained Canadian approval for Melacine, a cancer vaccine for Melanoma, and two US approvals for BEXXAR, a radio-immunotherapy for refractory and relapsed non-Hodgkins lymphoma.

“Personally I think we have one of the best development teams in the country as far as oncology goes. They’ve been there, done that. Coupled with Martin’s experience, it’s a real wow factor when you look at the background of this group.”

Moving forward the next step is to raise funds for Phase III clinical trials, the final stage before the drug can be sold. This will require an infusion of cash states Cormack.

“We’ve been ready to launch Phase III for probably a good six months already. But when you’re dealing with novelty in a marketplace where risk aversion has become a dominant theme, it can be a tough road. If we would have been born in a different time with different access capital like it was in the glory days, I think we would have been further along than we are today for sure.”

“One of the options we are looking into is a partnership for our Phase III clinical trials of OGX-011.”

The total budget for these studies is about $70 million, with only $17 million in the bank, the need for a partner or some other means of cash infusion can be a strain states Cormack and could lead to some tough decisions.

Cormack has already had to make some tough decisions to get the company to this point. His first tough decision came after the merger with Sonus Pharmaceuticals, a company that failed with its lead product and didn’t have much to show for it other than cash. Cormack was forced into laying off 27 employees, nearly half the Sonus work force, including 19 in Bothell and two in Seattle. The lay offs eventually left just seven employees at Sonus’ former offices in Bothell, which employed 64 prior to the merger. Likewise he had to lay off half of his own staff.

But the deal has worked out in the long-run, coupled with the results from Dec. 3, the company has enjoyed quite a reversal of fortune.

“It was a deal that just made a lot of sense and for us it came down to three key features. One is they were publicly listed on NASDAQ, which in turn allowed us to list on NASDAQ, second they had cash which we desperately needed, and third they also had product candidates in their pipeline that fell in line with our own products.”

OGX-011 isn’t the only product in the pipeline delivering positive results. In addition to that OncoGenex has its other programs coming through Phase I with OGX-427 being the next main one. OGX-427 is a second generation antisene drug, which in preclinical experiments has done well. It is designed to reduce production of Hsp27, a protein that is over-produced in response to many cancer treatments.

“We’re going to put a pretty big push to get the program into Phase II trials. That along with OGX-011 are probably the big two objectives for us.”

The company also has cancer drugs SN2310, CSP-9222, and OGX-225 in its pipeline, and Cormack is hopeful the same success the company has had with OGX-011 will be realized with these product candidates.

The key point states Cormack is the data. “I think it really differentiates our story from others. In the grand scheme, compared to our peers, I think we’ve rocketed forward. To have five Phase II’s completed with a lead, have two other programs completed Phase I and having the balance of a preclinical pipeline, that’s a pretty hard comparable.”

As Cormack puts it, he’s willing to “let the data” do his talking.