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Catalyst - Fall 2012 - Novel Technology Needs a Laser Focus

If there is one thing successful serial entrepreneur Dick Woodward, Ph.D., knows, it’s that anytime you try to do everything, you end up doing nothing. And that, he said, is one of the two biggest challenges startup biotech companies face. (The other one, incidentally, is CEO ego… but that’s an entirely different article.)

“I’ve been involved as a founder/cofounder, consultant or employee of about 14 early stage startups. One thing they all have in common is that generally speaking, small companies are resource poor. They get pulled in a lot of different directions and they wind up going nowhere,” explained Dr. Woodward, co-founder, president and COO of Vascular Magnetics, Inc. “You just cannot do everything at once. Companies that do that go away quickly.”

Vascular Magnetics is laser-focused on treating peripheral artery disease (PAD) with its novel technology -- Vascular Magnetic Intervention (VMI). The process involves magnetically targeting drug-loaded biodegradable particles into the affected area of the body. In the case of PAD, VMI is used to treat obstruction of the arteries in the legs.

The technology will be tested in animal studies through 2013. The company hopes to eventually leverage successful first-in-human trials to the point where it can sell the technology to another entity that will take it to market.

Georges Gemayel, Ph.D., executive chairman of the company, Dr. Woodward and the entire team are well aware that there are other applications for VMI, but they have decided to leave those opportunities for a different day. “We will let others take them on after we prove concept and enter into a strategic partnership. We are addressing only PAD,” Dr. Gemayel said.

MORE COMMON THAN YOU THINK, BUT STILL AN UNMET NEED

PAD is caused by atherosclerosis (plaque deposits) that obstructs the arteries outside of the heart. Most commonly found in the legs, PAD can cause crippling pain that severely restricts the patient’s mobility. Though it’s not a rare condition -- over 27 million people in North America and Europe alone some degree of PAD -- it remains a “serious unmet medical need,” Dr. Woodward said.

PAD is most common in people over 50 and diabetics and, while smokers are at extremely high risk, all PAD sufferers are at extremely elevated risks for heart attack and stroke. “This is a very deadly disease. The scary thing is that about two thirds of the people with PAD have no symptoms,” Dr. Woodward said.

Left untreated, PAD can result in the complete loss of blood supply to the affected leg.  This results in gangrene, and ultimately the amputation of the leg, which is associated with extremely high mortality rates.

While there are many effective treatments for conditions such as cardiovascular disease already on the market, there are no truly acceptable treatments for PAD in the marketplace today. Vascular Magnetics is quick to point out that current treatments for PAD – angioplasty, stents and grafts – are not effective, with restenosis occurring at a rate of 20 to 46 percent per year. Even drug-eluting stents, the standard of care in coronary artery disease, have shown no added benefit in treating PAD.

How can it be that PAD affects so many people worldwide – it is believed that about one quarter of Americans over 70 suffer from some form of PAD – and no company has successfully come out with an efficacious solution? The Vascular Magnetics team doesn’t know either, but it’s determined to be the company that solves the problem.

The company believes the solution lies in method of execution. Since evidence suggests currently available solutions have an inability to deliver a sufficient dose of drug to the arterial wall, Vascular Magnetics’ technology puts a sustained release composition of paclitaxel, a standard drug to prevent restenosis, directly where it needs to be with a magnetic targeting method, Dr. Gemayel explained.

“After balloon angioplasty or atherectomy to clear the obstructed artery or stent, the physician introduces the Magnetic Targeting Catheter (MTC) into the area of the artery to receive drug treatment,” he said. “The MTC contains a mesh of an alloy that cannot be permanently magnetized, but in the presence of a uniform magnetic field, high-force magnetic gradients are developed throughout the mesh and the adjacent arterial wall. This process allows the dosage of drug to be monitored easily.”

WHERE THEY’VE BEEN …

In a recent interview, Drs. Woodward, and Gemayel triumphantly started by saying the company incorporated on June 4, 2010. But truly, that date is only a midway point in the Vascular Magnetics story.

Like many startup technology companies, Vascular Magnetics began as simply a great idea from accomplished scientist Bob Levy. The William J. Rashkind Professor of Pediatric Cardiology at Children’s Hospital of Philadelphia, Dr. Levy also directs the Cardiology Research Laboratory at CHOP. While he had been involved in innovative stent research for a decade, it was Dr. Levy’s interest in the key mechanisms of VMI that got the attention of the University City Science Center’s QED Proof-of-Concept Program.

The QED Award facilitates interactions designed to accelerate the development of technologies and rapidly translate them into products available to advance patient treatments. Award winners are supported by the QED Program’s business development program with a 12-month, $200,000 grant for early-stage research and development that includes matching funds from the investigator’s research institution as well as guidance from industry and investment experts who periodically review the project and guide the technology from the QED program into the private sector.

Buoyed by the confidence CHOP placed in him, Dr. Levy wrote a paper on VMI that was judged by the venture community. When he learned that he had received the $200,000 award from the QED to support his scientific efforts, he set out to develop the VMI technology further. Perhaps just as important to Dr. Levy’s work, at that point, was the third component of the QED award, namely business advice from an advisor with a background in project development and implementation. Dr. Levy’s advisor was Dick Woodward.

Drs. Levy and Woodward worked together to identify a strategy for quickly translating the technology from an academic pursuit to a treatment reality. Those planning sessions led to the launch of Vascular Magnetics.

“In mid-May 2010, with the award in hand, we decided to start a company,” recalled Dr. Woodward, noting he went from “advisor” to co-founder. “We knew the next step to commercialization was proof in man, so we were going to have to do a clinical trial. We needed a legal entity.”

And, with that decision, on June 4, 2010, Vascular Magnetics became the first-ever spinout company from CHOP in its more than 150+ year history.

FAST FORWARD…

The QED award was generous, but certainly not enough to get Dr. Levy’s technology to the next step. “At the very end of 2010 and all through 2011, I did what I like to call `Dialing for Dollars,’” Dr. Woodward said. “I talked to anyone who would stand still long enough to listen about Vascular Magnetics and VMI, hoping I might pique the interest of an investor.”

After months and months of this Road Show, Dr. Woodward met with Devon Park BioVentures in Philadelphia in late 2011. Armed with a good story to tell, and no customary Powerpoint presentation, Dr. Woodward said he just talked about what the company was hoping to accomplish.

“Before I got back to my office, I was informed Devon Park had called and they wanted a confidentiality agreement.”

Following a $7 million A-Round in February of 2012 by sole investor Devon Park, the company set out toward tackling its go-to-market strategy.

For now, the team is operating in virtual mode, with all development work being subcontracted and preclinical testing in large animals being performed at the Cardiovascular Research Foundation in New York City. The company is aiming to move its clinical studies outside of the United States, quite possibly to South America where there is infrastructure in place to do trials that are quicker and cheaper but still very acceptable to the U.S. FDA.

Dr. Gemayel is a strong proponent of outsourcing and the virtual collaborative concept. “We could hire three or four great people who would have to wear 67 hats, or we can surround ourselves with the very best experts all over the place. For Vascular Magnetics, the option is clear,” he said. “We will go wherever the expertise is and hire the best in their fields. That’s the way we will succeed.”

 

EisnerAmper's Catalyst: Fall 2012

 

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