iBio's revolutionary plant based platform could transform the way drugs are developed

If New York-listed iBio (AMEX:IBIO) lives up to its full potential, then it has the capacity to transform the way certain drugs are developed.

The firm’s iBiolLaunch platform is a quicker, slicker and cheaper way of creating vaccines and other biologics.

It is also safer and more flexible than the current methods, which rely on mammalian cells.

“The current processes are regulator-controlled and compliant, expensive and slow and have severe biologic limitations,” chairman Robert Kay told Proactive Investors.

To date $70 million has been poured into developing the revolutionary gene expression system.

The Bill and Melinda Gates Foundation has met half this expenditure, with America’s Defense Advanced Research Projects Agency, known as Darpa for short, picking up the remainder of the tab.

The Gates’ see iBioLaunch as a catalyst for cheap vaccines for the world’s poor, while Darpa regards it as a possible weapon in its armoury against the bio-terrorism threat.

Also, more mundanely, it offers a quick turnaround on vaccines for strains of the flu virus, which, in this age of international travel, pose their own threat to national security.

“These days everyone has to have their own supply of vaccine secure in their own borders,” Kay added.

This is why the first application of the iBioLaunch platform has been in the development of an inoculation for the H1N1 strain of the virus.

Phase one studies began last September, and are being conducted out by Fraunhofer, a not-for-profit research organisation and the company’s de facto R&D arm.

Interim results published recently reveal the vaccine to be both safe and well tolerated at all doses. More importantly the immune response was strong.

“These expected positive results are an important confirmation of the utility of the iBioLaunch platform, not only for rapid response to infectious disease challenges such as influenza, but also as a preferred approach to a broad range of vaccine and therapeutic products,” said Kay.

The plan is to use iBioLaunch to target the “low hanging fruit first”.

With that in mind, the company plans to develop a treatment for Fabry disease, an inherited disorder that results from the build-up of a particular type of fat in the body's cells.

Sufferers have so few option that iBio has won orphan drug designation for an improved, plant-based version of an existing enzyme therapy, which would allow it to be fast-tracked through the regulatory and marketing process.

A deal with Bio-Manguinhos, announced in January, could see the creation of a Yellow Fever vaccine in Brazil using the plant-based technology pioneered by the company.

This agreement works on a number of different levels.

It represents iBio’s first push into the BRIC economies (Brazil, Russia, India and China), where an affluent middle class is demanding first-world drugs and healthcare.

This is part of a long-term strategy that will see it target these newly emerging markets, before moving on to the 'harder-to-crack' developed regions such as Europe and the North America.

It also presents the firm with the opportunity to gain a substantial chunk of the Yellow Fever vaccine market, though the deal with the Gates Foundation would see the poorest portions of population treated for free.

“Our plan now is to move into the earliest revenue generating opportunities, so that means plucking the lowest hanging fruit such as orphan drugs and Brazil,” said Kay.

“We are looking at orphan drugs because the process is scalable and we are able to economically able to address these orphan drugs.

“We recently announced acquisition of an orphan designation for enzyme replacement therapy for Fabry disease.

“This is a great example where sufferers aren’t being served properly, but it is a tiny patient population.

“Our entry into the market will also be via collaborative arrangements for particular drugs made on our platform and in selected markets where partners own those markets.

“This is our tactical approach. We will start picking off markets that are acceptable, and which we can get to quickly.

“We want to into the BRICs where there is not existing infrastructure and plenty of money and at the same time address the markets in US, Europe and Japan but without any desperation at all.”

The worry with any fledgling healthcare company is its constant requirement for fresh investment to fund often heavy rounds of research and development.

As we have seen, iBio has some powerful benefactors in the form of Darpa and the Gates foundation.

Even so it is reasonably well financed for a company of its ilk with around US$ 8 million of cash.

Outstanding warrants if exercised by investors could provide a further “$14-$15 million. “In other words we have enough working capital for the near-term,” said Kay.

“We hope in the next six months we will have a collaboration (deal) with one of the products we are working.”

And this of course would be another source of funds for iBio.  But partnerships are important not just from a financial standpoint.

Having “big brother” who can open doors to new markets can be a major boon to a developing company.

Ibio boss Kay found this out first hand on trip to China with the giant GE Healthcare.

“We have just finished a tour of three Chinese cities with them,” he reveals.

“GE regards our technology as a true enterprise solution for countries and companies that wish to use new technologies to produce biologics.

“We are very excited about the relationship. And this is part of the model: to select best in class collaborators. They can open up a territory for us in seconds as they did with China.”

There is competition out there, including the Canadian firm Medicago.  “They are using system that looks very much like us,” Kay said.

“They spending a lot of money, but the Megicago technology has no capability beyond vaccines. Ours works on all biologics.

“We view our technology as becoming a legal standard (in this arena) because it has so many advantages over the other systems.”