The Virtues of Devices

RIMON THERAPEUTICS PRESIDENT AND CEO MICHAEL MAY, PHD DEVELOPS THERAPEUTIC POLYMERS

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By Patricia Nicholson

The story of Rimon Therapeutics Ltd. (Toronto, ON) isn’t the classic tale of a diligent scientist stumbling on a discovery, and only then turning from the lab bench toward the challenges of entrepreneurship. Rimon’s co-founder, Michael May, PhD, set his sights on starting a company very early on, and kept his eyes open for a suitable technology.

“I’m fascinated with science, but even when I was an undergrad, I could see the other side and wondered where it was going,” May says. “It wasn’t being mined and built into something we could use more readily. It was like being surrounded by piles of gold and wanting to do something with it.”

The technologies that eventually caught his eye were therapeutic polymers: materials with biological activity that are used as solids, such as scaffolds, coatings or beads, to deliver localized benefits. Rimon calls these materials Theramers™, and is developing several products based on these core polymer technologies.

The Right Material
Rimon’s lead product is a therapeutic wound dressing called MI-Gel™ that corrects the balance of enzymes known as metalloproteases (MMPs). These enzymes are present in above-normal concentrations in chronic wounds. As the wound tries to heal itself, MMPs degrade tissue components, so the wound remains chronic. Examples of chronic wounds include diabetic ulcers, bedsores and venous ulcers.

MI-Gel works by binding MMPs, thereby taking them out of the biological process. The dressing has no chemical action, and is not metabolized.

“It’s a device, not a drug,” May explains. “But it ultimately has a therapeutic effect on healing.”

In April, the U.S. Food and Drug Administration classified MI-Gel as a device, which gives the product some strong development advantages over drugs.

“Clinical trials are much less cumbersome for devices,” May says. Rimon plans to start a six- to nine-month clinical trial this year for MI-Gel, more for marketing purposes than regulatory requirements. The goal is to find a development partner for MI-Gel next year, and then take it to market in another 12 to 18 months. Clinical data would be a bonus during negotiations.

The product consists of two polymers: beads of Rimon’s MI Theramer™ (MMP-inhibiting Theramer) suspended in ThermaGel™, a thermosensitive gel that is liquid at room temperature and gels at body temperature. The dressing is applied as a liquid, which then gels to the wound, and can be removed with cool water without pulling or sticking to the wound, or damaging new tissue.

“Successful products are rarely based on one technology,” May says. “We looked at how we could create a novel dressing.”

Rimon licensed in the thermally reversible gel and paired it with the company’s own MI Theramer to create a product with the desired characteristics. Wound healing, May says, is an area that has unmet needs. Problems that need to be addressed for chronic wounds include high MMPs, lack of blood supply, infection and pain.

“The industry is hungry for active therapeutic dressings and treatments,” May says, but he adds that these products need to be simple for nurses and other practitioners to use. The goal, May says, is to make a product that can be used like gauze, but which offers therapeutic benefits.

Rimon’s pipeline also includes Angiobeads™ — beads of a Theramer that helps facilitate the localized development of new blood vessels — which have potential applications in skin grafts, chronic wounds and surgical wounds. A cosmetic product is also in development: ThermaFill™ is an injectable, gel wrinkle filler that is a non-degradable, non-resorbable, synthetic alternative to treatments such as collagen. The company is also working on an antimicrobial product called AM Theramer™ that could be used as a coating, for which there are a number of applications. Infection, May says, represents a significant unmet need. “A host of medical devices suffer from bacterial colonization,” he says.

Ambitious Plans
May completed his PhD in chemical engineering at the University of Toronto (Toronto, ON). He had always intended to start a company, and says there were a number of potential technologies in the lab of his PhD supervisor Michael Sefton, PhD, who would eventually become Rimon’s other co-founder. Therapeutic polymers emerged from work on microencapsulation with polymer beads, performed in Sefton’s lab.

“The angiogenic Theramer was serendipitous,” May says. While working with a network of blood vessels, a contaminant was observed that appeared to have angiogenic properties. May calls it “a serendipitous observation on which we built a unique concept.” That concept — products with drug-like margins over device timelines — has now been validated by the FDA’s device classification, May adds.

The technology that would lead May and Sefton to launch Rimon was discovered in 1995. The pair founded Rimon in 1997, while May was still working on his doctorate. The name Rimon comes from the Hebrew word for pomegranate, which is a symbol of health and of springtime.

May finished his PhD in 1998, and Rimon got its first round of financing in 2000, which May says was the “real starting point” for the company, joking that it may have been a bit ambitious to try to finish a PhD, launch a company and start a family all at the same time.

His entrepreneurial ambitions were given a boost when May was awarded the Martin Walmsley Fellowship for Technological Entrepreneurship in 1996. The fellowship is intended to foster entrepreneurial spirit, and to help turn promising technologies into successful business ventures. The fellowship currently awards $100,000 over a two-year period ($50,000 in the first year, renewable for a second year), but at the time that May won it, it was a $35,000 fellowship. It is awarded to a researcher associated with the Ontario Centres of Excellence to help commercialize intellectual property.

“It reduces the risks,” May says of the award. “It gives them a salary, or helps pay legal costs.”

A key figure in technology development, he says, is the entrepreneur.

“There’s a great need to support that,” May says, adding that an entrepreneurial scientist willing to take on the challenges of commercializing a technology is a great model.

“To combine a science background with good business judgement is a powerful combination,” he says. “If I was inspiring students to put things together, that’s a good combination.”

May recalls that when he was a student, people couldn’t understand why he didn’t aspire to getting a job in the U.S., where the bulk of the biomedical engineering market was located. His response was, “That’s OK — I’ll create a job.”

Today, he says, students are more aware of opportunities. “They’re more entrepreneurial than when I was in school.”

Innovative Approach
For May, the major hurdles in building Rimon have been the familiar trinity of money, science and people — although he adds that “when you have the money, you can meet the other stuff more easily.”

But he also says that Rimon’s successes over the past three years have been more dependent on a spirit of innovation than on funding — or on the limits created by lack of funding.

“Money isn’t always the problem,” May says. “It’s about being innovative.”

Expertise in areas such as product development and regulatory issues helps, too, he adds.

“This is the hardest thing I’ve ever done,” May says of the many challenges presented by running a biotech company. “I’ve pulled more all-nighters and put in more hours building Rimon than anything else.”

The work is not without its rewards, though. May says Rimon has a great team of scientists. “It’s exciting working with people who are creative, innovative,” he says. “It’s very satisfying.”

The process has involved a lot of stress, but also a lot of thrills.

“What is exhausting is the roller coaster,” he adds. “The constant swing of ups and downs.”

Those swings can be related to funding availability and other business concerns, or to what’s happening in the lab. Science can be unpredictable, but Rimon was founded on a serendipitous observation, so surprises in the lab can be viewed as beneficial.

“Science never works the way you want,” May says. “But sometimes it works in great ways.”

Now that he is fulfilling the goal he nurtured since he was an undergrad, May says entrepreneurship is turning out much as he anticipated — only more so.

“In many ways Rimon has progressed as I envisioned it,” May says. “It’s what I expected, but it takes longer and it’s more extreme.” He laughs and quotes the rule of pi: that everything takes 3.14 times the amount of money and 3.14 times the amount of time as originally expected.

Once he had found his technology, launching a company was only the beginning for May.

“Starting Rimon was the easiest thing I ever did. Building it has been the toughest,” he says. “I do a lot of dreaming about Rimon and what it’s going to do. If you dream, you can make them happen.”