Seattle Genetics’ Medical Point Man, Tom Reynolds, Aims to Capitalize on Hodgkin’s Drug

9/8/08Follow @xconomy

The people at Seattle Genetics think they have a blockbuster-drug-in-the-making for Hodgkin’s disease. Tom Reynolds is the guy whose job it is to prove it to the world.

Few drugs ever demonstrate the kind of promise SGN-35 did in its initial clinical trial in June, says Reynolds, the company’s chief medical officer. The drug showed about half of patients had partial or total elimination of their tumors, even at much lower-than-expected doses, with limited side effects for a cancer drug. “This sounds like Gleevec. It sounds like Rituxan,” Reynolds says, referring to two of the biggest-selling cancer drugs ever, from Novartis (NYSE: NOVN) and Genentech (NYSE: DNA). With SGN-35, he says: “We are blessed. This drug will make it. It will help people.”

Seattle Genetics (NASDAQ: SGEN) has been on a roll this year, with its stock climbing 27 percent since June 3, when it announced SGN-35 results at the American Society of Clinical Oncology meeting. An estimated 8,000 patients in the U.S. are diagnosed with Hodgkin’s each year, looking for something new. Yet this is a company that’s been around for 10 years and hasn’t yet taken a drug into the final stage of clinical trials, much less delivered on its goal of creating a single marketed cancer drug. In the seven years I’ve covered the company, its lead drug candidates—SGN-10, SGN-15, and SGN-30—were never able to get over the hump with a successful Phase III clinical trial.

So what’s different now?

For one, SGN-35 is a different kind of drug. It’s an engineered antibody that can seek out cancer in the body, avoid healthy tissues, and also dump a tumor-killing dose of chemotherapy inside the tumor cells. The biggest-selling products in cancer treatment today, Genentech’s Avastin and Rituxan, are engineered antibodies that hit a specific target on cells, but they aren’t attached to toxic chemotherapy payloads that could give them more punch.

For another thing, Reynolds, 49, is there. He’s still relatively new, having started in March 2007. His resume is a little unconventional for the job. He is a scientist by training, with his Ph.D. and M.D. in biophysics from Stanford University. He was originally drafted to do development and clinical trial work at Seattle-based Targeted Genetics, he says, even though he is not a board-certified physician who treats patients. What he does have is more than 15 years’ experience in biotech drug development, making the rounds at all the major “genetics” companies in Seattle—Targeted Genetics, then ZymoGenetics, and now Seattle Genetics. He comes across as a true Northwesterner—as someone who likes to climb mountains and go kayaking in the San Juan Islands—and he complained a bit about the daily commute from his house on Mercer Island.

In his last job, at ZymoGenetics, Reynolds was vice president of medical affairs and oversaw the clinical development and new drug application for what became that company’s first marketed product, Recothrom. By his count, he’s worked on about a dozen applications to begin trials of experimental drugs, including some work with cancer treatments at Targeted Genetics.

At Seattle Genetics, the data is so promising, he says, that the company is holding meetings with the FDA to see if it can skip the middle stage of trials and go straight to a pivotal study that can prove the drug works, so it can get on the market as quickly as possible.

Seattle Genetics isn’t saying much about the next steps for SGN-35, because the company is still working on a plan with the FDA. Reynolds says he’s learned a lot from his experience over the years with the U.S. drug regulator. “There’s a lot of mistakes companies can make. One is when companies have some feeling that if you and the FDA don’t agree, and you think you’ve got your science right, you’ll win. That you’ll just ram it down their throats and win. Experience says that doesn’t work,” he says. “We don’t believe we can tell the FDA what to do. We seek a win-win.” He added: “It’s really a lot about attitude. We’re not going in there to tell them what to do or to pull the wool over their eyes.”

He made it clear the company intends to spend money to get the full answer about SGN-35, rather than cut corners with a smaller trial that gives some, but not all, of the information needed to say it’s a real drug. CEO Clay Siegall, a founder of the company and an Xconomist, has given Reynolds the resources to do the job. The company’s clinical group has grown from 22 when Reynolds started to 70 people now. “Clay wanted to hire someone to build what we needed to go the distance,” Reynolds says.

Going the distance means doing studies the right way, he adds. “We don’t do Hail Marys, and we don’t bet the company on one product,” Reynolds says. “We’re moving toward a Genentech-type approach on when you do the right studies.”

The company expects to unveil its plan for the right study for SGN-35 before the end of the year. Open for discussion with the FDA right now: the choice of dose, the treatment schedule, the patient population, whether patients are randomized to the drug or a control group, and what the key measurement of success will be. Getting those moving parts all properly aligned, and then carrying out the trial so it can go all the way to approval, is something few biotech companies ever get right. Wall Street seems to like the odds for now, but it will be a long time before we really find out whether Reynolds and his team have made all the right moves.

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