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29 October 2014Americas

TapImmune: tapping into innovative cancer treatments

In just five years Glynn Wilson, chief executive of TapImmune, estimates the Seattle-based company will be worth more than a $1 billion. It’s a big claim to make for a company that currently is not making money but Wilson sees no reason why it can’t aim for the top.

The company’s primary function is treating cancer and infectious disease through immunotherapy. Rather than using traditional chemotherapy techniques, which seek to kill cancerous cells, TapImmune’s philosophy centres on boosting the body’s immune system to fight disease.

“The real problem we are trying to solve is finding a way to stimulate the body’s cellular immune system to kill cancer cells and virally infected cells,” Wilson tells LSIPR.

“By contrast, the current methodologies, which include chemotherapy, can sometimes kill healthy cells as well as cancer cells so they are limited in their use. If you can stimulate the cellular immune system appropriately you should avoid those kinds of toxicities.”

TapImmune’s primary concerns focus on treating HER2/neu type breast cancer and infectious diseases. It has also announced plans to foray into ovarian cancer treatment.

Although very much in the preliminary stages, the company is currently conducting clinical trials and Wilson is convinced its methods are the way forward.

“We have put together what we call a ‘prime and boost’ strategy,” explains Wilson.

“The strategy involves stimulating T-killer cells, which help to kill cancer cells, and T-helper cells, which allow T-killer cells to thrive. It’s an approach that people see as the future of cancer treatment and is potentially far less toxic than current approaches.

Protecting the method

When using IP to protect these methods, the company’s strategy reflects Wilson’s confidence of success and the long-term viability of TapImmune.

It currently has five patent families, each with several accepted and pending applications for various technologies.

But while it may appear to be taking these steps just to get a foothold in the market, Wilson is fully aware of the need for long-lasting protection.

“We have seven issued patents with multiple applications,” Wilson tells LSIPR. “These include old patents and newly issued patents. But with multiple applications it should cover us for the next 20 or more years.”

In a recent company development statement, TapImmune described a long-lasting patent strategy as “a key component to success”.

“It is highly unlikely that early patents will extend through ultimate product marketing, so extending patent life is an important strategy for ensuring product protection,” the statement adds.

It’s the subject of patent management that brings Wilson onto the subject of TapImmune’s work with Seattle-based IP law firm Seed IP and former patent agent Robert Florkiewitz.

Florkiewitz, who acts as the company’s director of molecular biology, was appointed primarily for his knowledge of molecular and cell biology but is also on hand to advise the company on its patent applications and protections as it seeks to bring its inventions to the market.

This will prove useful, says Wilson, in future partnerships, including work to protect one of TapImmune’s more recent inventions, its PolyStart technology.

PolyStart is a new vaccine platform that creates a four-fold increase in antigen presentation.

“It’s a very exciting new technology that gives multiple initiation sites in a piece of DNA [instead of just one],” Wilson explains.

“The convention when coding DNA for protein is that one DNA can create one protein. What we are doing is saying that we can create multiple initiation sites that give you four proteins for every one piece of DNA.”

Wilson is not just excited about the technology; he is confident that US patent law will work in his favour when developing treatments.

“If you look at the current patent landscape in the US, there are issues about natural sequences which follow the Myriad case (Association for Molecular Pathology v Myriad Genetics). We still don’t know what it’s going mean long-term but the bottom line is that a strategy has to include novel composition; in our case that means novel vaccine compositions,” Wilson says.

“That’s one of the reasons we think our PolyStart technology will be very important in the future—it’s a totally novel composition of matter.”

Although it has not faced any serious issues protecting its IP—Wilson says the company has not experienced anything that was “unexpected”—he reveals that TapImmune’s lucrative methods have made it necessary to keep some of its technologies under wraps.

“We do also have trade secrets so we are using the full gamut in terms of IP but we will be looking more and more at those as we move along. We are looking at trademarks as well but they are fairly easy in comparison.

"Former patent agent Robert Florkiewitz is on hand to advise the company on its patent applications and protections as it seeks to bring its inventions to the market."

“In the case of one of our other programmes, which covers immunity to folate receptors [a protein that transports folate into cells], the market is smaller than 200,000 patients. For that we will be applying for orphan drug status which, if approved, will give us market exclusivity when the product is launched.

“I think that is an important aspect of IP protection which goes hand in hand with other IP such as patents and trademarks.”

Big opportunities

Patients with HER2/neu type breast cancer, TapImmune’s primary concern, make up around 20% of breast cancer patients in total.

But, while this is “a very high number”, Wilson says, it leaves about 70% to 80% who can’t be treated. Wilson views this as a “large market opportunity.”

Despite TapImmune’s different approach and potential market, there are notable rivals in the field of cancer treatment.

Arguably the best known is pharmaceutical company Roche and its breast cancer drug Herceptin (trastuzumab). The drug has had sales of around $7 billion in the last year with “only a small fraction of the market” treated.

Herceptin, alongside Roche’s other cancer drug Perjeta (pertuzumab), is probably the most notable competitor when considering what the company is trying to achieve, Wilson says.

However, there are other rivals specifically in the field of immunotherapy.

“If you look at immunotherapy in general in terms of head-to-head competition we would look to a company called Galena Biopharma.

“They are in more clinical trials but we have shown through various peer-reviewed papers that the approach we have is more comprehensive,” Wilson says.

“There are clearly other companies, each with different approaches, but ours is probably the most comprehensive,” he adds.

Wilson points to three reasons for this: the stimulation of T-killer cells, stimulation of T-helper cells, and the company’s efforts to improve antigen presentation and the restoration of antigen presentation in tumour cells.

Although currently spending and not gaining, Wilson is confident about the future success of TapImmune.

“The programmes we have are nicely poised to branch out into other treatments. For example, the HER2/neu antigen is also present in colorectal cancer and our methods for treating ovarian cancer are also applicable to difficult to treat diseases such as triple negative breast cancer.

“Because of this flexibility we can start mixing and matching antigens and there’s no reason why that cannot be done to make an exciting new approach.”

He adds: “I see no reason why we cannot be a billion-dollar company in five years’ time and a leader in immunotherapy with multiple clinical programmes.”

Wilson is clearly no stranger to the competitive market of breast cancer treatments and is confident of success.

The appointment of a former patent agent is testament to its commitment to protect its inventions and even at this early stage TapImmune’s potential success could be a turning point in the treatment of cancer.